INORGANIC CHEMISTRY

1. 1.1 WHAT IS PHARMACEUTICAL CHEMISTRY ?
Pharmaceutical chemistry is a science that makes use of the general laws of chemistry to study
drugs i.e., their preparation, chemical nature, composition, structure) influence on an organism and
studies, the physical and chemical properties of drugs, the methods of quality control and the conditions
of their usage. In other words, it is the chemistry of drugs. Drugs mainly exert action depending upon
the biochemical pathways.
Pharmaceutical chemistry is a specialised science which depends on other chemical disciplines such
as inorganic, organic, analytical; physical and colloid chemistry and also on medico-biological disciplines
such as pharmacology, physiology, biological chemistry, etc.
Pharmaceutical chemistry occupies the most important place among the related sciences such as
drug technology, toxicological chemistry, pharmacognosy, the economy and organisation of the
pharmacy.
1.2 IMPORTANT ASPECTS OF PHARMACEUTICAL CHEMISTRY
Pharmaceutical chemistry is the chemistry of drugs and of medicinal and pharmaceutical products.
The different important aspects of pharmaceutical chemistry are as follows:
(1) It includes the various methods for isolation, purification and characterisation) of medically
active agents and materials from natural sources (mineral, vegetable, microbiological or animal) which
find various uses in the treatment of diseases and in compounding prescriptions.
(2) It includes the various syntheses of medicinal agents that could not be obtainedfrom natural
sources or the synthetic duplication due to reasons of economy, purity or adequate supply of substances
obtained from natural sources.
(3) It includes the various synthetic methods by which natural substances are converted into products
with more favourable therapeutic or pharmaceutical properties.
(4) It includes the determination of the derivatives or forms of a medicinal agent which shows
optimum medicinal activity and at the same time results in the stable formulation and elegant dispensing
(1)

2. ganic Vol-
Pharmaceutical Chemistry (Inorganin
2
(5) It includes the determination of chemical and biological incompatibilities among the
ingredients of a prescription.
the various
and
(6) It helps in the establishment of safe and practical standards with respect to both dosas
quality in order to maintain uniform andtherapeutical standards for all torms of medication
tion
hg
(7) It helps in the improvement and promotion of the use of chemical a8ents for preventi
ilness, alleviation ofpain,cure of diseases and search for new therapeutical agents especiallv
there exists no satisfactory remedy.
when
1.3 INORGANIC PHARMACEUTICAL CHEMISTRY
inorganic substances as drugs, i.e., their preparation, chemical nature, compoSition, structure,influe
on an organism, etc.
Inorganic pharmaceutical chemistry is a science that makes use of the laws of chemistry to s
ence
The main source ofinorganicdrugs happens to be the natural source such as minerals. There
many reports on the use of minerals in medicine. Some interesting examples of these include miners
waters, salts, partially purified inorganic chemicals, calcined inorganics (ash or bhasma), and chemical.
transtormed inorganics. At a later stage, many of these were found to be poisonous substances but ars
being still used cautiously by some doctors in sufficiently small quantities. Thus, the ancient physicians
were quite familiar with the use of antimony, arsenic and mercury.
are
re
are
In ancient Indian medicine system mercury was supposed to occupy a dominant position for
sometime and whole treatises were written giving its therapeutic and other properties. Many noble
metals like gold and copper were also used in medicine. The use of minerals as medicinal agents were
not restricted to any single country but all ancient cultures were quite familiar with their medicinal
uses.
Although many inorganic chemicals are rarely employed today, yet few inorganic chemicals are
being still used in modern medicine. Synthetic organic chemicals are able to replace the more toxic
inorganic pharmaceuticals. Most of these belong to one or other of the following categories:
(1) Those that find use for replacing or replenishing the normal content of the body. These are
required for normal physiological processes and are required in diet. But disease conditions are able to
deplete their amounts in the body. Hence they have to be replenished or replaced. Calcium, sodium
potassium, magnesium, iron, chloride, phosphate, bicarbonate, oxygen, etc., are examples of this
category.
(2) Those that are used for changing reactions of body fluids, ie, acidify or alkalise. Mineralacids
antacids, alkalis etc., belong to this category.
(3) Those that find use as medicinal and therapeutic agents in disease conditions. These may be able to
change physical (eg., topical agents, protectants), physiological and/or biochemical processes (eg
astringents, respiratory stimulants, hypnotics, expectorants). Some may be used as correctives or n
infections (eg., dental products, antidotes, antimicrobials etc.).
(4) Those that find use as pharmaceutical aids. Bentonite, talc, antioxidants, pigments etc. are example
of this category.
(5) Those that find use in analytical and quality control processes. Most of inorganic chemica
included in the Pharmacopoeia belong to this category. Titrants such as permanganate, dichromat
iodine, bromate etc., buffers like phosphoric acid salts, boric acid salts, ammonium salts etc. are useru
examples of this group.

3. c
Vol-)
Introduction
to
Pharmaceutical
Chemistry
3
various
(6)
Those
that
are
used
as
reagents
for
carrying
out
other
reactions.
Some
inorganic
substances
find
use
as
catalysts
(platinum,
nickel,
charcoal
etc.),
some
as
oxidizing
or
reducing
agents
(chromic
acid,
lithium
aluminium
hydride
etc.),
some
as
adsorbents
in
chromatography
(alumina,
silica
gel
etc.)
and
in
other
several
ways.
age
and
ntion
of
lly
when
The
term
pharmaceutical",
is
used
for
any
chemical
that
finds
use
in
the
preparation
of
medicament
for
internal
administration
of
the
human
body.
Some
find
use
only
in
the
laboratory
during
the
preparation
but
may
not
be
present
in
the
final
product.
These
are
also
incorporated
under
pharmaceuticals.
All
pharmaceuticals
must
be
carefully
controlled
for
their
quality.
For
this
purpose,
specifications
of
quality
have
been
listed
for
each
pharmaceutical.
A
collection
of
such
descriptions
has
been
reported
in
a
Pharmacopoeia.
to
study
infuence
1.4
PHARMACOPOEIA
Pharmacopoeia:
(Gr.
Pharmakon
a
drug,
and
poiein
to
make)
is
a
book
of
directions
and
requirement
for
the
preparation
of
medicine
it
is
generally
published
by
an
authority
Thus
pharmacopoeia
is
a
legislation
of
a
country
which
sets
standards
and
obligatory
quality
indices
for
drugs,
raw
materials
used
to
preparethem
and
various
pharmaceutical
preparations.
These
regulations
are
presented
separately
in
general
and
specific
articles.
There
are
le
mineral
chemically
ces
but
are
physicians
osition
for
lany
noble
gents
were
medicinal
Monograph:
is
a
complete
description
of
a
specific
pharmaceutical,
which
includes
nomenclature,
clasification,
physical
characteristics,
dosage,
purity,
limits
for
impurities,
identification,
assay
and
conditions
for
storage.
The
appendices
may
also
include
standards
for
apparatus,
other
chemicals,
techniques,
processes
etc.
related
to
the
said
pharmaceutical.
The
world's
most
comprehensive
source
of
drug
information
in
a
single
volume
is
published
periodically
by
the
direction
of
the
Council
of
the
Pharmaceutical
Society
of
the
certain
nations
and
prepared
in
the
Society's
Department
of
Pharmaceutical
Sciences.
icals
are
ore
toxic
It
is
the
traditional
activity,
aiming
to
provide
unbiased
concise
reports
on
the
actions
and
uses
of
most
of
the
world's
drugs
and
medicines
to
help
the
practising
pharmacists
and
physicians.
In
every
publication
monographs
are
accurately
organised,
reflecting
therapeutic
practice
and
the
needs
of
today's
pharmacist.
Details
are
provided
for
new
compounds
in
the
form
of
new
monographs
accompanied
by
the
deletion
of
some
of
the
previous
monographs
not
in
continued
use.
The
overall
effect
provides
an
increase
in
the
average
of
drugs
with
typographical
improvements
to
assist
the
reader
in
locating
sections
of
a
monograph.
These
are
re
able
to
sodium,
s
of
this
Abstracts
of
the
relevant
aspects
of
important
or
useful
papers
and
other
publications
are
included
with
referenced
reviews
of
important
or
contentious
topics.
The
coverage
is
given
for
the
proprietary
names
for
preparations
containing
more
than
one
active
ingredient.
The
proprietary
names
identify
manufacturers.
al
acids,
able
to
es
(eg
Some
of
the
developing
therapeutics
are
revised
in
Pharmacopoeia
continuously
with
the
search
for
fective
treatment
of
AIDS.
It
also
includes
information
of
antiviral
agents.
Genetic
engineering
techniques
provide
more
optimistic
theme
for
the
production
of
improved
antiviral
activity
of
the
new
drug.
The
drug's
notable
features
for
the
treatment
of
infections,
and
development
of
antiviral
antiprotozoal,
antibacterial
therapy
are
reviewed
and
renewed
and
discussed
in
pharmacopoeia.
Advances
in
the
cardiovascular
group
of
drugs
are
included
in
every
new
edition
along
with
new
approaches
in
the
treatment.
es
or
in
amples
emicals
omate,
useful
There
are
other
areas
of
advances
covered
in
the
publications,
e.g,
antineoplastic
agents,
antiparkinsonian
drugs.
Resistance
is
a
continuing
concern
with
antimalarial
compounds.

4. 4 Vol-I
P h a r m a c o u t l o a l
ChomistrY (Inorgania v.
O 1S based on the published information divided in different major parts. zaenn
Part
comprised of chapters.
Part I generally brings together drugs that have similar use or actions af the chapters are w
to guide the reader to the drug that may be of interest in related chapters. MOs m
ences are us
wili
c o n
providing background information on that group of drugs having iary comn,
actions.
Fart Il includes monographs on new drugs, on drugs under investiga
dSSea, and on obsolescent drugs still of interest. Jt also provides details regarding
e n e e s
o tequire
drug therapy.
Part m, in this publication gives composition of the proprietary meaic orH
Public in differernt countries and ae generally described by the manufacturers. rne
been omitted.
u y the pharmaceuticals which are
commonly and currently in use are inCiuaed
1n the
plarmacopoeia.
The substances which are found to be undesirable from past experience and
wich are
y not
in use are excluded. The chemicals which are used for application
or internal coisumption
Dy n u m a n
beings, form the part of pharmacopoeia, The chemicals which are commerclauy avallaole in
Pure state and which are commonly used for other p u r p o s e s are excluded. In the pnartldoPela only
m i n i m u m standards for a chemical are prescribed. However the manufacture may supPPY
u e s e with
re sngent
standards. Thus a medication has to comply strictly with any one of the pharmacopoeias
n o t it may be considered substandard and usuallynotprescribed by standard
medical practitioners.
Only those mentioned in the pharmacopoeia are
considered official as per the legislation
ot
thecountry
1.5 HISTORY OF P H A R M A C O P O E I A
Every country has legislation on pharmaceutical
preparations
that sets standards and obligatory
quality
indices for medicaments, raw materials, and preparations employed in the
manufacture of
drugs.
These regulations are presented in separate
articles-general
and specific relating
to individual
drugs, and are published in the form of a book called a Pharmacopoeia.
The word Pharmacopoeia is
derived from the Greek words pharmakon, a drug or
medicine and poieo, to make.
The first British Pharmacopoeia (B.P.) was published in 1864. It was including monographs on
benzoic acid, gallic acid, tartaric acid, tannic acid, camphor, lactose, sucrose and seven alkaloids along
with their salts. The first United State Pharmacopoeia (U.S.P.) was
released on 15th December, 1820.
Indian Pharmacopoeia
In India, in the pre-independence days, B.P. was employed as the official book of standards. The
first edition of the Indian Pharmacopoeia (I.P.) was published in 1955. It was having a large number of
crude drugs and their preparations.
The third edition of the I.P. got published in 1985. Addendum Ito
third edition has been published in 1989.
The Addendum I to the Pharmacopoeia
of India 1985 amends the Indian Pharmacopoeia
1985 and
constitutes a part of Indian
Pharmacopoeia,
third edition.
The General Notices and Appendices
included in the Indian Pharmacopoeia 1985 and as
amended
in this
Addendum apply both to the matter contained in the Indian Pharmacopoeia 1985 and to the
matter
contained in this
Addenduun.

5. Introduction to Pharmaceutical Chomistry
In India there are laws dealing with certain of the substances which are the subject of monographs
which follow. These monographs should be subject to the restrictions imposed by those laws wherever
they are applicable.
It is expedient that enquiry be made in each case in order to ensure that the provisions of any laW
are being complied with.
In general, the Drugs and Cosmetics Act, 1940, the Dangerous Drugs Act, 1930, and the Poisons Act,
1919, and the rules framed thereunder should beconsulted.
Under the Drugs and Cosmetics Act, the Indian Pharmacopoeia is the book of standards for drugs
incuded therein and the standards as included in the Indian Pharmacopoeia would be official. If
considered necessary these standards can be amended and the Secretary of the Indian Pharmacopoeia
Committee is authorised to issue such amendments. Whenever such amendments are issued, the Indian
Pharmacopoeia would be deemed to have been amended accordingly.
The Govermment of India constituted a permanent Indian Pharmacopoeia Committee in 1948 for
the preparation of the Indian Pharmacopoeia and keeping it up-to-date. The first edition of the Indian
Pharmacopoeia was published in 1955, followed by a supplement in 1960. The second edition of the
Indian Pharmacopoeia and its supplement were published in 1966 and 1975 respectively. The third
edition of the Indian Pharmacopoeia was published in 1985.
Each later edition supersedes the previous one. There are also supplements (Addendum), on each in
1960, 1975, 1990 and 1992. In order to keep the Pharmacopoeia accurate, authoritative and up-to-date,
the Ministry has established a Central Indian Pharmacopoeia Laboratory (at Ghaziabad) and an Indian
Pharmacopoeia Committee.
TheAddendum () to the third edition amends the Indian Pharmacopoeia 1985 and is published by
Government of India, Ministry of Health and Family Welfare on the recommendationof Indian
Pharmacopoeia Committee (in accordance with Drugs and Cosmetics Acts, 1940, Dangerous Drugs Act,
1930 and the Poisons Act 1919, and the rules framed thereunder).
Indian Pharmacopoeia, 1996 2 volumes, 1182 p, figs.
The latest edition of the Indian Pharmacopoeia was published in 1996. Underthe Drugs and
Cosmetics Act, 1940, the Indian Pharmacopoeia is the legally recognised book of standards for the
quality of drug substances and their preparations included therein.
Contents: Volume I: Notices. Preface. Acknowledgements. Introduction. General notices.
Monographs (A-O).
Volume II: Monographs (P-Z). Infra-red reference spectra. Apperndices. Index.
"The Indian Pharmacopoeia is the legally recognised book of standards for the quality of drug
substances and preparations included therein. This new edition, which supersedes the 1985 edition and
its addenda, includes many new drugs and their dosage forms and, omits others as also amends
the specifications and updates standards of others keeping in view the advances in pharmaceutical
sciences.
"The contents are accommodated in two volumes as was the case with the earlier edition. It contains
1149 monographs and 123 appendices dealing with reagents and test procedures to be used for
ascertaining compliance with the standards. Some new tests have been added. A special feature is the
inclusion of infra-red reference spectra of a number of drug substances. The general notices, which

6. Pharmaceutical
C h e m i s t r y
( I n o r g a n i c Vo
in tinted
provide the basic guidelines for the
interpretation
and application ofstandardsy
paper to highlight this important part of the compendium.
a p p l i c a t i o n
of
s t a n d a r d s ,
a r e
printed
acket)
"The
Pharmacopoeia
is indispensable forallconcerned
with the quality
or
arg y
"The
Addendum 2000 veterinary is a companion
is indispensable
for all concerned with the quality of drugs." (jac
1996 which
volume to the
Indian
P h a r m a c o p o e i a
.
jacket) No. 19078
armacopoeia
Addendum 2000 anmends as well as adds new drugs and j
1996 with a view to keeping the Pharmacopoeia
existing
monographs
and appendices,
it contains 44 new monograp
undergone major
amendments. The appendix on
Bacter
new
version which includes the quantitative
tests in additio
p r e p a r a t i o n s
to the
Indian
Phar
updated
to the extent
possible.
Besides
amending
raphs.
Some
m o n o g r a p h s
har
the
have
with a
terial
E n d o t o x i n s
Test
has
been
replaced wit
tion to the
c o n v e n t i o n a l gel
clot test.
"The veterinary
Supplement2000to the Indian
P h a r m a c o p o e i a
1996 is
indispensable
for all
c o n c e r n e d
with the quality of veterinary
medicines." (jacket) No. 19079
"India has a huge
livestock wealth. It needs me
diseases in animals. As medicines for veterinary
use cons
armamentarium,
it was thought appropriate to prepare
details specifically for drugs and preparations
meant
2000 is the first ever such publication. As it is an adjunct compendi
1996,
standards for the quality of medicines
included
therein will have the same legal
authority
as
those included in the Indian Pharmacopoeia
1996."
m e d i c i n e s
for diagnosis,
prevention
and
t r e a t m e n t of
c o n s t i t u t e a
significant
portion
of the total drug
a separate
volume
containing
all
relevant
for veterinary
use.
The
Veterinary
Supplement
endium to the
Indian
P h a r m a c o p o e i a
"The monographs
of the Venterinary
Supplement
2000 are
divided into two parts.
Part I deals with
non-biological
preparations
whereas Part II c o v e r s
biological
products.
As the quality
standards
are the
same for all medicines,
whether used in humans or in animals,
monographs
of drugs
and
preparations
included in this Supplement
but already official in IP 1996 contain
information on
doses
and strengths of dosage
forms only."
eir
"Four appendices
describe the details of procedures
specifically
for testing
certain biological
veterinaryproducts.
The tests
included in various appendices of the Indian Pharmacopoeia
1996 are to
be referred to for other preparations.
For ease of reference, the General
Notices in the Indian
Pharmacopoeia
1996, which are the key to the interpretation
of the standards, are reproduced
after
editing suitably,
and are printed on
distinctive blue paper,
as in the Indian Pharmacopoeia
1996."
Constant
collaboration
between
countries in the field of public
health and drug production
necessitated the
establishment of common,
unified requirements
for the quality of drugs, and
consequently,
unified methods of analysing
them. For this purpose,
the International
Pharmacopoeia
was
created. It is published
under the auspices of the World Health Organization and is a collection of
recommended requirements
on drug quality. The
International Pharmacopoeia is not a legal document
for any country,
but it provides the basis for establishing
national requirements on drug quality. At
present, the 2nd edition of the
International Pharmacopoeia (published in 1968) along with the
supplement to it (1971) are in use. Specialists of many
countries took part in preparing the second
edition of the International Pharmacopoeia.
In 1981, the first volume of the 3rd edition of the International
Pharmacopoeia
was published. It includes the general methods of analysis.
This book has been dealing with the study of inorganic substances, that have been official in the
Indian Pharmacopoeia.
The word 'oficial, normally represents what is official in I.P., B.P., U.S.P. and
in anv other authoritative book of the country. All the important inorganic compounds that are official
in I.P. and have been commonly
used in pharmacy, have been described here.

7. Jol-I)
o-I)
nted Introduction to Pharmaceutical Chemistry
In Pharmacopoeia, each pharmaceutical has been described under a monograph. The various standards
described require other chemicals, apparatus, techniques, processes etc., which are not the subject of
other monographs. All such items are again described in appendices to the Pharmacopoeia, with
precise specifications for these necessities. For a pharmaceutical chemist and an analyst the apPpendices
are considered as important as the main body of monographs. Only those pharmaceuticals which are
commonly used in the recent past have been included in the Pharmacopoeia. Substances which have
proved to be undesirable from past experience have to be removed from Pharmacopoeia. Substances
which are commercially available in excellent purity and are commonly used for other purposes are
also generally not included, due to redundancy. However, if such substances find use internally, then
they are included in the monographs. The standards prescribed for a chemical are the minimum. It
does not prevent a manufacturer from supplying these with more stringent standards. If a substance
has not been included in the Pharmacopoeia, it does not imply that it cannot be used or marketed. Such
non-official substances must correspond to standards prescribed either in the earlier editions of the
Indian Pharmacopoeia or in other recognised Pharnmacopoeia (of other countries). In this country products
corresponding to the British Pharmacopoeia (B.P.) and United States Pharmacopoeia (U.S.P) are generally
marketed. Other better known Pharmacopoeias International Pharmacopoeia (1.P.),European Pharmacopoeia
(E.P.) and U.s.s.R.P. To avoid confusion between Indian and International in the abbreviation, sometimes
IND. P. or P.l. may be written for Pharmacopoeia of India. However, unless otherwise specified, in this
country 1P. will be generally understood as Indian Pharmacopoeia. There are other compendia
prescribing standards for pharmaceuticals. Some of these have been: British Pharmaceutical Codex (B.P.C.)
and National Formulary (u.s.N.E.). Any substance which fails to correspond to any official standard
should not be used, in the interests of proper health.
hich
eia
the
ave
h a
ned
of
ug
ant
ent
eia
as
th
ne
ir
Medicinal substances and pharmaceutical aids included in monograph of the latest edition of the
Pharmacopoeia deem to be official substances in the country of Pharmacopoeia. It is of utmost inmportance
to understand the difference between chemical individual and an official substance with same name.
An individual chemical can be pure to any specified purity but the official substance isa commercial
product which is required to comply with certain standards of purity specified in the Pharmacopoeia
and may often have some other substances, added for specific reasons; for example Chloroform of the
Pharmacopoeia contains 1-2% of added ethyl alcohol to prevent the formation, and to inactivate any
poisonous phosgene (carbonyl chloride) gas that may be formed in contact with the air during storage.
2COC1,
Carbonyl Chloride
(phosgene)
OCH
CO
OCH
Official Substance
eS
al
to
er
2HC1
2CHCl O
CI HOC,H
2HC
CO
Cl HOC,H (Diethyl carbonates
(relatively non-poisonous)
To specify, a particular compound/substance being official, the official name is specified with
capital initials eg. Sodium Chloride, Aluminium Hydroxide. However, the reference/meaning is clear
from the context, the capital initials are not employed/repeated unnecessarily.

8. Vol-l
Pharmaceutical Chemistry (Inorganji
8
Pharmacopoeial Description/Presentation
Mostly, all pharmacopoeias consist of the three main sections namely (a) Introductic
a) Introduction : It is a useful pointer to pharmaceutical progress since last edition becau
summarises the various changes/additions/deletions in the current edition. Attention should be
tion includi
General Notices; () Monographs of the official drugs; and (c) Appendices
P
later part
OGeneral Notices" at the outset so as to avoid misunderstanding and misinterpPre
of the text.
1o1
) Monograph of Official Drugs, Preparations and Substances :The word O g P Imple
the written study of a subject. "As the medicinal substances are to be used for the cure and or preventin
of diseases, therefore, these are considered as very important and hence their written studies appear
Monograyphs' in the Pharmacopoeia. For the convenience, the monographs are somewnat stereOtyped in
style and the arranged in the alphabetical order of their names. The pharmacopocial monogrphs (fo
example in LP. 1985) give the following information about the drugs and pharmaceutcal aids
(1) Title: The title is stated in English and refers to the official name of the compouna. Sometimes
sub-titles are given. These are synonyms and could be used in place of the main title eg, Calciur
carbonate can also be called precipitated chalk, iron and ammonium citrate can also be called feri
ammonium citrate; milk of magnesia can also be called magnesium hydroxide mixture.
2 Formula weight and molecular weight: Following the title has been the
chemicalformula of the
pure compound, with its molecular weight,eg, MgCl,.6H,O Mol. wt.202.30; KMnO, Mol.wt. 158.03 etc
These two items are not given, provided the correct chemistry is not known or the compound is uf
indefinite composition. For example, for iron ammonium citrate, formula and mol.wt. are not given.
3) Category: This describes the therapeutic or pharmacologic or pharmaceutical application of the
compound. Usually this is the main application, although the compound may be having other
applications. Some main categories for inorganic pharmaceuticals mentioned in the Pharmacopoeia
include haematinic; antacid; laxative; pharmaceutical aid; astringent, etc.
4) Dose: These are the quantities for the guidance of the prescriber or the physician to achieve
the desired therapeutic effects in adults. It can be altered as and when required, eg., CaCO, dose
1 to 5 gm.
This is omitted for substances not used for internal administration. Usual strength may be given for
pharmaceutical dosage forms, like injection etc., which is the most commonly marketed dosage strength.
5) Description: This gives a physical description of the substance like crystalline or amorphous
nature, colour, odour, taste, etc. These properties help in the preliminary evaluation of the integrity of
an article and not themselves the standards or tests of purity, eg, CaCO, fine, white microcrystalline
powder, odourless, tasteless.
t6) Solubility: Solubility is described in popular terms, which are defined in the Pharmacopoeia
under general notices. This is usually 8iven in water, sometimes in hot or boiling water, in alcohol, in
glycerol, in solvent ether and sometimes in other organic solvents, acids or alkalis.
Colubility for an article given in the monograph may be considered primarily as information, but it
it is given under the quantitative solubility test, then it 18 a standard. If the exact solubility of the article
is not known, a descriptive term is used to indicate its solubility. The following table reveals the
meaning of such term.

9. Introduction to Pharmaceutical Chemistry
TABLE 1.1
Descriptive Terms Relative Quantities of Solvent for 1 part of Solute
Less than 1 part
From 1 to 10 parts
From 10 to 30 parts
From 30 to 100 parts
From 100 to 1000 parts
From 1000 to 10,000 parts
More than 10,000 parts
Very soluble
Freely soluble
Soluble
Sparingly soluble
Slightly soluble
Very slightly soluble
Practically insoluble
'(7) Standard : It is an important part ofmonograph, which specifies the quantitative purity of the
title compound, where the compound is of definite composition, e.g., (1) Potassium bromide is having
not less than 98.0 per cent of KBr, calculated with reference to the dried substance, e.8,
(2) Hydrogen peroxide solution is an aqueous solution of hydrogen peroxide. It contains not less than
5.0 per cent w/v and not more than 7.0 per cent w/v of H,O, corresponding to about 20 times its volume
of available oxygen. It is having not more than 0.025 per cent w/v of a suitable stabilising agent.
If the composition has been not definite, the standards are vaguely defined, e.g., (1) Bentonite is a
natural, colloidal, hydrated aluminium silicate, e.g., (2) Dried aluminium hydroxide gel consists largely
of hydrated aluminium oxide and varying small quantities of basic aluminium carbonate and bicarbonate.
It contains not less than 47.0 per cent of Al,Og
Standards stated in the monograph of the Pharmacopoeia apply only to articles which are intended
for medicinal use and not to articles sold for other purposes, e.g., starch.
(8) Identification: This usually involves specific chemical test or tests for identifying the substance.
Colour reactions, precipitating tests, and gas evolving reactions are commonly used for inorganic
pharmaceuticals.
Identification tests are not absolute proof of identity. It provides a means of verification only, e.g.,
phenol.
Phenol FeCl, solution gives violet colour.
(9) pH: The pH values given in the monograph are for the guidance of manufacturing pharmacist to
develop various dosage forms and to avoid physiological complications, e.g, calcium amino salicylate.
2 per cent w/v solution gives pH 6.0-8.0.
(10) Limits for impurities: For different chemicals different limit tests have been included, as also
different amounts of such impurities permissible for that chemical. The various tests that are included
could be any of these: acidity or alkalinity, ph, specific impurities (like phosphates, sulphides, magnesium,
Darium etc.), arsenic, heavy metals, chloride, sulphate etc. These will be dealt with in another chapter
on Quality control and Tests of purity.
Limit tests for impurities are generally represented in parts per million by weight (ppm) or as a
percentage. These are approximate values.
(11) Assay: It is a step-by-step description of a chemical analytical method for the active substance.
If the assay method described in the Pharmacopoeia is applied to the chemical, the standards prescribed
in the monograph earlier should be realised. For most inorganic pharmaceuticals, titrimetric or gravimetric
methods are used.

10. rganic Vol-
Pharmaceutical Chemistry (Inorganic
(12)
Storage: This is the last item under the
monog
the
activity of the
chemical. These are
generally brief and
general,
Condition. For
inorganic
pharmaceuticals, the
Pharmacopoeia uses
thee e etc.
this
implies the
substance is
stable and gets protected from dust,
airt
Container, (b)
tightly-closed containers; the
substance in such cases
Be
or
moisture or
carbon dioxide (e.g., reducing agents, hygroscop e etc, it may also include sur
iso
incude such
compounds as are
volatile or contain dissolved gases etc.
1t
compounds as are
volatile or
contain dissolved gases etc. (c)
light-resi ce
are arected by light are
stored in amber or
dark-coloured containers; (d) cool
place; tnis is
applicablet,
Substances which are
affected by warm climate (e.a..
thermolabile substances); for some
solution
reezin8 1s to be
avoided; (e) single-dose containers:this is
generally prescribed ror sonne
njectable,
which once
opened, should not be used again.
Precautions to be taken where there is a
possibility of effect of atmosphere,moisture
eservi,
the
monograph. These directions are useful in
preser.
ded more as
guidance than a
ting intot
eric oxyy
etc.); it m
ubstances whi
light
s a
possibility of effect of atmosphere, moisture, heat and lig
ditiona
are
indicated where
appropriate in the
monog
Protection against light is
necessary, the bottle must further be covered with a black paper.
e.g., Ferrous fumarate- Store in a
light resistantcontainer.
graph. In certain specified instances when additio
.8, Insulin
injection Store in multiple dose containers at a
temperature between 2 to 8'C. It
should not be allowed to freeze.
1.P.also prescribes conditions for the storage of some official substances which are
likely to
deteriorate, if not stored properly. The terms used under definite meanngs of the
pharmacopoeia are:
Terms
Pharinacopoeial meanings
Any temperature not
exceeding 8° and usually between 2°C and 8° C.
Any temperature betweern 8°C and 25°C. An article for which storage in a cool
place is directed, may alternatively, be stored in a
refrigerator (at temperature
between 2°C and 8°C), unless otherwise specified in the individual monogrph.
The temperature prevailing in a
working area.
Cold
Cool
Room Temperature
Any temperature between 30°C and 40°C.
Warm
Any temperature above 40°C.
Where no
specific directions are indicated in the individual monograph, it is to be
understood that the storage conditions include protection from moisture, freezing
Excessive Heat
Storage under non-specifie
and excessive heat.
(13) Appendices The General Notices and Monographs are
followed by a
comprehensive section of
Appendices. The Appendix 1 describes the apparatus that are needed for various pharmacopoeial tests
and assays. In particular the standards and tolerances tor Nessler's cylinders, thermometers, volumetric
glassware and weights and balances are laid down in this Appendix. The Appendix 3 includes the
details of various chemical tests and assays. Some
physical tests and determinations like loss on drying,
determination of pH, melting range etc.
rorm part or Ppenaix >. Useful directions on cleaning glassware
oscribed in Avpendix 6. Reagents and
solufiorns needed in the various tests and assays, their
method of preparation, standards etc. have been described fully in Appendir7 Th assays,
.. in the Pharmacopoeia for weights ana measures ana ot elements and their atomic weights have
been described in the Appendix 9.
aQE hroadly includes following 91 categories of
Appendices (with several sub-appendices)

11. Introduction to Pharmaceutical Chemistry 11
Appendix
Number
Number of Sub-appendices under each
Appendix
(3)
Type ofAppendix
(1) (2)
6
Apparatus for Tests and Assays
Biological Tests and Assays
Chemical Tests and Assays
41
29
3.
7
Microbiological Tests and Assays
Physical Tests and Determinations 19
General Information
7. Reagents and Solutions
. Reference Substances
9. Tables 2
1.6 EXTRA PHARMACOPOEIA (MARTINDALE)
Although no explanations have been included in the Pharmacopoeia, it is having wealth of
information. Anyone who consults the Pharmacopoeia often, should familiarise himself with the general
notices and the various appendices. Most comprehensive information on every type of pharmaceutical
or drug can be obtained from the Extra Pharmacopoeia (Martindale, 29th Edn.). This excellent work has
been especially rich in therapeutic and clinical information on the drugs. There are several other useful
literature references for inorganic pharmaceuticals. Some of these have been included at the end of this
book.
The Extra Pharmacopoeia was first edited, compiled and published in 1883 by William Martindale
(1840-1902), a practising pharmacist. Its main aim was to provide physicians and pharmacists with
practical and up-to-date information concerning drugs and gelenicals to supplement that was included
in the British Pharmacopoeia. Four editions of "Martindale" were published in the span of three years.
Up to 1910, the accumulation of information became so great that the subject matter had to be
divided into two volumes. The first double-volume edition, the 15th, appeared in 1912. The copyright
of the Extra Pharmacopoeia was acquired by the Pharmaceutical Society of Great Britain in December
1933, upon the death of Dr. W. H. Martindale, son of William Martindale, and since then the society is
continuing to issue it under the editorship of the Director of its Department of Pharmaceutical Sciences.
The 24th edition of volume I was published in 1958 and 23rd edition of Volume II in 1955. A supplement
was published in 1961. The 25th edition appeared in February 1967 while the 26th edition was released
in July 1972. Now the highly acclaimed Martindale (1993) now in its 30th edition, contains up-to-date
authorative information on drugs and medicine in use throughout the world. It is written for the
practising pharmacists and physicians and for all those involved in use of drugs and medicines.
This new edition of Martindale has been markedly changed in order to meet the requirements of
today's reader. These changes include a massive increase in formation on proprietary medicines, a
significant shift to a more clinical emphasis, an increase in the number of referenced reviews, and
shortening of the usual period between editions to meet the need for up-to-date information.
1.7 BRITISH PHARMACOPOFÍa
The reason for the appearance of a British Pharmacopoeia is ascribed to the Medical Act of 1858,
Section 54 which stressed the need of publication of a book having a list of medicines and compounds,

12. Pharmaceutical
C h e m i s i y
( L n o r g a n i c V
they are
Vo.-i
12
poeia,
1864
w a s
a n
o u t c o m e
of the
comi
rmacopoeia Londinensis (1618),
oeia
(1807).
New
e d i t i o n s
and
a d d e n d u m
foll
dendurm
n in 1874, a
3rd
e d i t i o n
in
1885,
a
f u r t h e r
adde
weights
and
measures by
w h i c h
mbinatior
the m a n n e r
ofpreparing
them, together
with true
prepared
and mixed. The First British
Pharmacopo
three old and reputed
Pharmacopoeias
namely
Pharn
Pharmacopoeia
(1699) and Dublin
Pharmacopoeia
(18
quick
succession,
the 2nd in 1867, an
addendum
in
1890 and a 4th edition in 1898.
Edinbu
followed
Preparations ar
The British
Pharmacopoeia
1864
included
separate
parts:
Materia
Medica
and
P r e p a r a t i o n s a
parts:
M a t e r i a
M e d i c a
and
Compounds.
In the 1867
edition the
contents
had been
several other Pharmacopoeias.
ad
been
arranged
a l p h a b e t i c a l l y
as per
A gap
in revision delayed the next
edition until 1914.
he technic:
oeia
1914 it w a s
r e a l i s e d
that the
In Britain after publication
of the British
Pharmacopoe.
complexity
of the drug
sepecifications
was
increasing
prepare
the
Pharmacopoeias.
As such in 1928, the
became
responsibility
of the
C o m m i s s i o n . It was ther
ng
and a
d i f f e r e n t
kind ofset up
w a s
needed
onwards
led
heBritish
P h a r m a c o p o e i a
from
1932
edition
and.
P. must be revisec
hen
r e c o m m e n d e d
that
the B.P.
every ten years.
n 1952 revision, a range
of diagnostic
materials
was
included.
An
important
a d d i t i o n
was
made
t:
n c l u d e
s t a n d a r d s
and tests for antitoxins and
insulin. The
interim
between
1932 and
next 7th edition
1948, was
covered by s e v e n
addenda. In 7th edition of1948, generic
n a m e s
were
provided
for
substances
newly
i n t r o d u c e d
into
medicine.
Methods of analysis,
disintegration
tests for tablets and
sterilization
methods
were
expanded. Manynew
monographs
related to penicillins
and sex
h o r m o n e s
w e r e
included
At this time, it was
decided that the normal
interval
between
new
editions
should be five
instead of 10
years,
due the rapid
pharmaceutical
and
pharmacological
progress
that had been
made.
The next
edition appeared
in 1953. The titles of drugs and preparations
w e r e given in English
instead of Latin.
A b b r e v i a t e d
Latin title was
retained as a synonym.
Capsules,
constituted as new
group.
The implant
methods for sex
hormones and their
standards
were
described. The 9th edition
(1958) was having 160 new
monographs.
Tranquilising drugs and
s p e c t r o p h o t o m e t r i c
analysis
were
added. The tenth edition appeared in 1963.
In Medicines
Order 1970, the duties of the British Pharmacopoeia
Commission were
defined. The
thirteenth
edition of British
Pharmacopoeia
(1980) was the first edition of Pharmacopoeia
that was
prepared strictly
under the provisions
ot
Medicines Act. Currently the British Pharmacopoeia
starts
publishing
in two
volumes due to an expansion of drug
information.
The British
Prarmacopoeia
(1993) has provided
authoritative standard for the quality of many
substances,
preparations
and articles used in
medicine and pharmacy for some 130 years. This new
edition
consolidates and extends the 1988 edition with its 1989, 1990, 1991 and 1992 addenda, and for
the convernience for the user also incorporates
tne monographs of the European Pharmacopoeia.
Volume I deals with medicinal and pharmaceuical substances. It also includes the infrared reference
sDectra needed for the identification of manyorthe
materials. Volume II contains sections on formulated
ducts, radio-pharmaceutical preparations and.
surgical
preparations,
blood products,
immunological produ
n a t e r i a l s .
addendum to the British Pharmacopoela
193 includes monographs for a substantial
of substances
and preparations
tor the irst ime. Also included are the followino:

13. 13
Introduction to Pharmaceutical Chemistry
Several new European Pharmacopoeia monographs, revisions to monographs, edited texts relevant
to the human medicine that have been published fascicule 17 of the second edition of the European
Pharmacopoeia, replaces the limit test for particulate matter. An indication of the approximate levels of
impurities controlled by chromatographic tests wherever appropriate. A new supplementary section
containing auxilliary material of relevance to users of the Pharmacopoeia.
1.8 EUROPEAN PHARMACOPOEIA
European Pharmacopoeia is regarded to be an official book of standards adopted by Germany,
France, Italy, Netherlands, Switzerlandand Belgium. Council of Europe issued an order in July, 1964 to
frame out European Pharmacopoeial Commission for compiling European Pharmacopoeia. The first
edition of European Pharmacopoeia appeared in 1969 and its official standards become applicable
within the respective member countries. The second edition is being published in a series of volumes.
1.9 PHARMACOPOEIA INTERNATIONALIS (INTERNATIONAL PHARMACOPOEIA)
There appears to be no uniformity in terminology and strengths of pharmaceutical preparations
used in various countries. As early as 1874 view had been expressed that some world uniformity in the
standards for potent drugs must prevail. These views got further support at an international conference
in 1902 and an agreement was framed. No progress was achieved until a second international conference
got held in 1925 where an International Agreement on the Unification of Formulae for seventy-seven
potent drugs and preparations got reached. The Health Organisation of the League of Nations established
in 1936, a Technical Commission of pharmacopoeial experts. After the World War II over in 1946, the
work was undertaken by the World Health Organisation. Volume I of the long-awaited Pharmacopoeia
was finally published in 1951, in Latin, with translations into English and French. It was having
monographs for over two hundred drugs and chemicals; with appendices on reagents, tests and biological
assays. The Volume IL, published in 1955 included formulae for preparations having various drugs and
substances already present in Volume I. The supplement of 1959 incorporated some newer drugs and
substances with the method of preparations and the appropriate tests. The second edition got published
in 1967, followed by a supplement in 1971. The third edition got published in the form of several
volumes, Volume I appeared in 1979.
Although the International Pharmacopoeia cannot be imposed legally on any country, the
pharmacopoeial authorities of all countries are expected to give due considerations to its standards so
as for achieving uniformity of standards as far as practicable.
1.10 UNTTED STATES PHARMACOPOEIA (USP)
In 1817,Dr.Lyman Spalding of New York proposed a plan to the Medical Societyof the Country at
New York for publishing a National Pharmacopoeia. The first edition ofUnitedStatesPharmacopoeia
was compiled, edited and published on 15th December,1820 which was having 217 drugs in about
272
pages.Subsequent editions of USP appeared after the gap of ten years. In 1905, the nineth edition of
USP was published. However, it was given the title of USP VIII, as to show that it was eighth revision.
USP considers 25°C as the standard temperature for specific gravity and solubility statements. The 1940
Convention directed that the Pharmacopoeia must berevised every 5 years.
On July 5, 1974, unification of the USP and NF (National Formulary) was announced. Since then the
subsequent editions consolidate USP and NF into a single volume. All drug substances and drug
products were covered in USP whereas NF is devoted exclusively to pharmaceutical ingredients.
The XXII edition of USP combined with XVII edition of NF was published in January, 1990.

14. corporates upd
etd ehology
that are relevant to the
development
Sourceup
nd
provisio of
me
sugport ior the cortinuing education of
graduates, with speial
emphasis
s 12thedition has ben completely revised and
ireh suyect areas.The new Codex provide a
reference source on all as
eutics and demonsy
nd use. The
nes from conception and development to production and
ergraduates ard s
Per covers the multidisaplinary natureof pharmar
12
and th
e phermaceytics content of the syllabus for pharmacy
prepa
three
pharmaceutical data, arranged in
monograph form The C
harmacrutical Society, using known experts to write individual
Pharn
assriated with product development and
innovation. Part II
includes
The Codex is
edited
quick
ual chapters.
1890
TI
Com
1.12 ANNOTED EXTRACTS FROM
PHARMACOPOEIAMONC
sever
BT WAY OF A REPRESENTATIVE EXAMPLE
A
In
comp
prep
becar
NH
ever
2HCI, 240
inclt
Cao 24N,2044
1948
new
OH
met
Amodiaquin hydrochloride
At t
Other Name:
Camoquin (available in certain overseas countries only)
yea
A
Standard is Given in the British
Pharmacopoeia 1973.
Description: A
yellow odourless
crystalline powder with a
bitter taste.
Solubility: Soluble at 20°, in 22
parts of water and in 70 parts of alcohol; very shgnuy
ins
grc
(1s
and in chloroform.
ad
Acidity. A2h
solution has a
pH of 4.0 to 4.6.
Moisture Comtent: 6 to
10o,
determined by drying over
phosphorus
Storage. It
should be
stored in
airtight containers. phosphorus pentoxide in vacu
ldentification Test: To 1 ml of 2%
solution
precipitate is produced.
st:
To 1 mi of 2%
solution add 0.5 ml of cobalt
thioy
Melting Point: About 158C. Soluton
Determination in
body fluids:
Spectrofluorimery: In
plasma or
serun
World Health
Organisation, 1974, 51, 431.
Ultraviolet
Absorption: In 0.1 N
hydrocholoric acid,
maxima a *
(E 1, 1 cm
366).
m, 237 nm,and
Metabolism Absorption: Readily absorbed after oral
administration.
or
serum G.M. Trent

15. Introduction to Pharmaceutical Chemistry 15
Blood Concentration: After an oral dose of 10 mg/kg, plasma concentration of 300 to 560 mg/ml are
attained in 4 hours; therapeutic concentration are attained 1 to 2 hours after dosing.
Distribution: Widely distributed troughout the tissues, high concentrations are found in the liver,
spleen, kidneys, and lungs with smaller amounts in the brain and cerebrospinal fluid, in the blood,
higher concentrations are found in red cells than in the plasma.
Excretion: Slowly excreted in the urine but the rate may be increased if the urinary pH is decreased.
Action and Uses: Amodiaquin hydrochloride is an antimalarial drug, which has actions and uses
similar to those described under chloroquine phosphate
A dose equivalent to 200 to 400 milligrams of the base given orally once a week is usually adequate
for the suppression or so-called prophylaxis of malaria in an adult; 130 milligrams of the hydrochloride
is equivalent to 100 milligrams of the base. A single dose equivalent to 600 milligrams of the base is
often sufficient to control a malarial attack although the equivalent to 400 to 600 milligrams of the base
daily for 3-days may be necessary.
The dose in terms of the base for a child corresponding to 600 milligrams of the base for an adult is:
up to one year 75 to 150 milligrams; 1 to 5 years, 125 to 250 milligrams; 6 to 12 years, 270 to 450
milligrams. Amodiaquin has been used for the treatment of chronic discoid lupus erythematosus, a
single dose equivalent to 200 milligrams of the base is given daily until the condition iscontrolled
Undesirable efects: Undesirable effects are rare with antimalarial dose but it may cause nausea,
vomitting, diarrhoea. Long continued use of the drug may result in blue-gray deposits in the cornea,
fingernails, and hard palate. The corneal deposits slowly resolves after stopping treatment.
Preparation
Amodiaquin Tablet: Available as tablets containing amodiaquin hydrochlorideequivalentto 200 mg
of amodiaquine base. A standard for these tablets is given in the British Pharmacopoeia 1973.
Containers and Storage: See the entry on tablets for general information on containers and storage
containers should be airtight.
Labelling: A lable on the container should state the amount of the medicament as the equivlent
amount of amodiquine base.
Advice for patients: A tablet should be taken at regular intervals, preferably after meals. For
prophylaxis, doses should be taken during the period at risk and for 4 weeks thereafter
1.13 THE DRUGS AND COSIMETICS ACT, 1949
Scope
The Drugs and Cosmetics Act, 1940 has been enacted for the purpose of proper enforcement and
the purpose is that no substandard drugs be sold in the market and no one will sell even genuine drug
without licence.
The Drugs and Cosmetics Act does not contain any special provisions which would override the
general provisions of code of criminal procedure, and general provisions of Cr. P.C. will apply.
The Drug Act is mainly concerned with the standard and quality of drugs manufactured in this
country and therefore controls the manufacture, sale and distribution of drugs. This act is not related to
excise duty or impositions on narcotic drugs.

16. organic
Vol
-
Pharmaceutical
Chemistry
(Inorgar
16
The
Drugs
and
Cosmetics
Act,
1940
Objects
and
Reasons
glation
of
international
trafic
in
all
the
drugs
covered
by
the
convention.
.
Regulations
of
manufacture
of
and
internal
traffic
in
certain
specified
drugs,
such
and
morphine
n
view
of
the
obligation
undertaken
by
the
Government
of
India
tne
o
uch
as
cOcair
Definitions:
In
this
act,
unless
there
is
anything
repugnant
in
ne
>
gSAYurvedic,
Unani
or
Siddha)
include
all
medicines
intended
for
internal
or
external
u
animals
tor
or
in
and
the
diagnosis,
treatment,
mitigation
or
prevention
of
disease
or
disorder
in
human
beings
Oyurvedic,
Siddha,
and
Unani
Tibb
svstem
of
medicinel,
specified
in
the
first
Schedule.
(a)
"Drug":
It
includes:
u
r
e
d
exclusively
in
accordance
with
the
formulae
described
in
the
authoritatiy
medicines
for
internal
and
external
use
of
human
beings
or
animals
and
al
substances
ntended
to
be
used
for
or
in
the
diagnosis,
treatment,
mitigation
or
prevention
or
any
disease
or
isorder
in
human
beings
or
animals,
including
preparations
applied
on
human
body
tor
the
purpose
of
repelling
insects
like
mosquitoes,
(17)
Such
substances
other
than
food,
intended
to
affect
the
structure
or
any
function
ot
the
human
body
or
intended
to
be
used
for
the
destruction
of
[vermin]
insects
which
cause
disease
to
human
beings
or
animals,
as
may
be
specified
from
time
to
time
by
the
Central
Government
by
notification
in
the
official
Gazette,
(1)
All
substances
intended
for
use
as
component
of
a
drug
including
empty
gelatin
capsules,
and
(io)
Such
devices
intended
for
internal
or
external
use
in
the
diagnosis,
treatment,
mitigation
or
prevention
of
disease
or
disorder
in
human
beings
or
animals
as
may
be
specified
from
time
to
time
by
the
Central
Government
by
notification
in
the
official
Gazette
after
consultation
with
the
Board.
Cosmetics
Cosmetics
means
any
article
intended
to
be
rubbed,
poured,
sprinkled
or
sprayed
on,
or
introduced
into,
or
otherwise
applied
to
the
human
body
or
any
part
thereof
for
deansing,
beautifying,
promoting
attractiveness,
or
altering
the
appearance,
and
includes
any
article
intended
for
use
as
a
component
of
COsmetics.
Thus
the
definition
of
'
d
rugs'
in
Section-l
(@)
of
the
Drug
Act,
1940
is
comprehensive
enough
to
take
not
only
medicines
but
also
substances
intended
to
be
used
for
the
treatment
of
human
beings
and
animals.
The
expression
"substance"
must
not
be
s
like
cotton
wool,
roller
bandages
and
gauze.
strictly
medicines
but
somethir
hing
used
for
treatment
Standard
of
Quality
(a)
In
relation
to
a
drug,
that
the
drug
complies
with
the
standard
set
e
(b)
In
relation
to
a
cosmetic,
that
the
cosmetic
complies
and
lies
with
such
standard
as
may
be
The
act
vests
the
Central
Governmentt
make
rules
prescribing
the
methods
of
test
or
analysis
to
prescribed.
methods
of
test
or
analysis
to
be
employed
for
determining
whether
a
drug
is
of
standard
quality.
The
rules
prescribed
for
the

17. Introduction to Pharmaceutical Chemistry 17
purpose are contained in Rules of the Drug Rules published (or notified). The Pharmacopeia prescribes
the standard proportion of contents of the drug or cosmetic. If these content proportions are not
maintained then the defendant is liable for legal action.
Misbranded drugs
A drug shall be deemed to be misbranded:
(a) if it is so coloured, powered or
polished that damage is concealed or if it is made to appear of
better or
greater therapeutic value than it really is; or
(6) if it is not labelled in the prescribed manner; or
c) if its label or container or
anything accompanying the drug bears any statement, design or
device which makes any false claim for the drug or which is false or
misleading in any particular
manner.
Adulterated drugs: The drug shall be deemed to be adulterated:
(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or
(6) if it has been prepared, packed or stored under insanitary conditions whereby it may have been
contaminated with filth or whereby it may have been rendered injurious
(c) if its container is composed in whole or in part of any poisonous or deleterious substance which
may render the contents injurious to health; or
(d) if it contains any harmful or toxic substance which may render it injurious to health; or
(e) if it bears or it contains, for the purposes of colouring only, a colour other than one which is
prescribed; or
health; or
) if any substance has been mixed therewith so as to reduce its quality or strength.
Spurious drugs: A drug shall be deemed to be spurious:
(a) if it is imported under a name which belongs to another drug; or
(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner
likely to deceive or bears upon it or upon its label or container the name of another drug unless
it is plainly and conspicuously marked so as to reveal its true character and its lack of identity
with such other drug; or
C) if the label or container bears the name of an individual or company purporting to be the
manufacturer of the drug, which individual or company is fictitious or does not exist; or
(d) if it has been substituted wholly or in part by another drug or substance; or
(e) if it purports to be the product of a manufacturer of whom it is not truly a product.
Licence to sel, stock, exhibit or offer for sale or distribute drugs by retail other than those
specified in [Schedules C, C (1) and [X] [Rule 61 (1)]
Licence Form 20 is to be filled in by the official drug distributor having following proforma:
1..s hereby licensed to sell, stock or exhibit for sale or distribute by retail drugs other than those
specified in [Schedules C, C (1) and x] of the Drugs and Cosmetics Rules, 1945, and to operate a
pharmacy on the premises situated at.subject to the conditions specified below and to the provisions of
the Drugs and Cosmetics Act, 1940 and the Rules thereunder.
2. The licence shall be in force from.. to

18. janic Vol
Pharmaceutical Chemistry (Inorgaan
18
3. Name(s) of
qualified person(s) in charge...
4.
Categories of drugs . . .
Date.. Licence No.. Licensing Authority]
Conditions for Licence
(1) This licence shall be displayed in a prominent place in a part of the premises open to the puh
(2) The licence shall comply with the provisions of the Drugs and Cosmetics Act 1940 and the R.
(3) (1) No drug shall be sold unless such drugs are purchased under cash or credit memo from
(i) No sale of any drug shall be made to a person notholding
ndition
the requisite
shall
licence
not apply
to sell,
to
stoct
the sal
i
Ru
thereunder for the time being in force.
duly licensed dealer or a duly licensed manufacturer.
exhibit for sale or distribute the drug, provided that this condition shall not apPly to the sal
of any drug to.
a) an officer or
authority purchasing on behalf of Government, or
(0)
a hospital, medical, educational or research institution, or a registered medical
practitione
for the purpose of supply to his patient [or]
(a) a manufacturer of beverages, confectional biscuits and other non-medical products, wvher
such drugs are
required for processing those products.
4) The licensee shall inform the Licensing Authority in writing in the event of any change inth
constitution of the firm operating under licence. Where any change in the constitution of firm take.
place, the current licence shall bedeemed to be valid for a maximum period of three months from th
cdate on which the change takes place unless, in the meantime, a fresh licence has been taken fromth
licensing authority in the name of firm with the changed constitution.
Questions
Questions
1. What is meant by pharmaceutical chemistry?
2. Discuss the important aspects of pharmaceutical chemistry.
3. What is the importance of chemistry in pharmacy?
4. Discuss the history of pharmaceutical chemistry.
5. What is meant by Pharmacopoeia? Discuss the history of
Pharmacopoeia.
6. What is meant by the term monograph? What are the contents of monograph?
7. Define and explain the following terms:
(a) Assay (b) Monograph (c) Official compound (d) Pharmacopoeia.
8. Write in brief about "storage of pharmaceutical compounds".
9. Explain the terms:
(i) Pharmacopoeia (i) Monographs
10. What are B.P., U.S.P. and I.P.? Explain briefly ?
11. What are the contents of monog:aphs in general ?
12. Give a brief extract of pharmacopeial monograph ot a
representative pharmaceutical,
13.
(n
Give
Standard
the of quality, (ii) Misbranded drug. () Adulterated drug, (i») Spurious drug.
13. Give the definitionof:
14. Describe how the development of
pharmaceuticals can be carried out