Development of Indian Monograph

1. Prepared By,
Manish Mudaliar
M.Pharm,
Semester-III
Dept. of QARA
LJ Institute of
pharmacy
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2. Indian Pharmacopoeia Commission (IPC)
• Vision
▫ The IPC is committed to the promotion of the
highest standards for drugs for use in the
prevention and treatment of diseases in human
beings and animals keeping in view the special
features of the pharmaceutical industry in India.
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3. INDIAN PHARMACOPOEIA
MONOGRAPH DEVELOPMENT
• Objectives:
▫ The overall objective has been the creation of a
compilation of standards that reflect the state of the
industry in the country and the production and testing
capabilities of units varying in size from the small to the
very big.
▫ Special efforts have been made to safeguard the interests of
the weaker sectors of the industry without compromising
the safety and efficacy of the medicines included in the
Indian Pharmacopoeia (IP).
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4. Features:
• Priority is given to monographs of drugs included in the
National Essential Drugs List and their dosage forms
• Regular up-gradation of monographs but consistent with
the level and degree of sophistication acceptable to the
majority of manufacturers.
• Harmonization of IP standards with international
acceptance criteria for drug quality
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5. Quality Standards:
Following points should be under consideration
during setting of standards:
• Neither high nor low
• Should not be avoidance of sophisticated
instrumentation or methodology
• Recognition of the difficulties of the small- and
medium sized units of the industry
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6. Quality Standards cont… :
• Retention of simple tests where complicated methods
offer no advantage
• No compromise on limitation of toxic impurities
• Gradual tightening of standards over the years
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7. Overall philosophy:
• The Indian Pharmacopoeia is the official book of
standards and medicines produced in India must
comply with the specified standards.
• Pharmacopoeial standards and acceptance criteria are
set with the intention that they should be used only as
compliance requirements and not as requirements to
guarantee total quality assurance.
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8. Overall philosophy cont…:
• Pharmacopoeial standards are the minimum ones with
which a manufacturer must comply before release of a
product for sale or distribution
• It is recognized that changes in quality may occur during
storage and distribution and the Pharmacopoeial
requirements are set to define acceptable levels of change
and to reject materials or products showing unacceptable
levels
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9. Overall philosophy cont…:
• It is the responsibility of the manufacturer to ensure
that the product is manufactured in accordance with
current Good Manufacturing Practices.
• Pharmacopoeial requirements for drug substances
have been drawn up to provide appropriate limits for
potential impurities rather than to provide against all
possible impurities and adulterants.
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10. Contents of the Pharmacopoeia
• The technical part of the pharmacopoeia shall be
broadly divided into the following sections:
1. Introduction
2. General Notices
3. Monographs
4. Test methods
5. Reagents and Solutions
6. General Texts
7. Index
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11. Formats and Contents of Monographs
1. A one-column format shall be used for all the pages
of the monographs.
2. The font shall be Arial and the size for the text
matter shall be 10 pt.
3. Reagents, buffer solutions, chemicals other
substances that are described or defined in the
Pharmacopoeia shall be in italics.
4. Italic types shall also be used for the systematic
names of plants and micro- organisms, and for some
sub-headings of tests and texts and for some parts of
the chemical names.
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12. 5. Titles of monographs and headings of tests must be
began with capital letters in bold letters and aligned on
the left with the text. Synonyms, if any, shall be printed
two spaces below the main title and shall not be in bold
letters.
6. Single-line spacing shall be followed and the alignment
of the text of the monograph shall be ‘justified’. Each
test parameter and the accompanying text shall be
separated from the other by a space of 1.5 lines.
7. Given in the following pages are directions on the
manner in which the various tests and assays are to be
described. Where the instructions are in red, the texts
shall appear in the monographs in exactly the same way
as shown.
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13. A. Active Pharmaceutical Ingredients
(APIs) (Bulk Drug Substances)
Chemical Excipients
1. Title of the Monograph
• Name of the item in bold letters in font Arial size 12 pt. The INN
approved by the WHO shall be used.
• Synonym shown below the main title (in ordinary letters) The main
monograph headings viz. Identification and Tests etc. shall be in
Arial size 11 pt, and the headings of the individual tests in size 10
pt, and all in bold letters
e.g. Sodium Aminosalicylate
Sodium PAS
2. Formula
• Structural (Graphic) Formula
• The molecular formula on the left and the molecular weight
expressed to one decimal place on the right, two spaces below the
graphic formula.
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14. 3. Chemical name: Ethionamide is 2-ethylpyridine-4-
carbothioamide.
4. Statement of purity: Ethionamide contains not less than
98.5 per cent and not more than 101.0 per cent of
C8H10N2S, calculated on the dried basis.
5. Description: A pale yellow oil with slight, but not rancid
odour.
6. Identification: The tests shall be marked with the letters
A, B, C and so on followed by a dot and then the text
after one space.
e.g. A. Determine by infrared absorption spectropho
tometry (2.2.40). Compare the spectrum with that
obtained with ceftazidime RS or with the reference
spectrum of ceftazidime.
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15. 7. Appearance of solution: The solution is clear and not
more intensely coloured than reference solution.
8. pH
9. Specific optical rotation
10.Light-absorbing impurities : The absorbance (2.2.25)
of the resulting solution, determined at 495 nm is not
more than 0.07 calculated on the dried basis.
11.Related substances: Details of the method-usually by
thin-layer, or liquid chromatography or gas
chromatography shall be given.
12.Arsenic: Method of preparing the test solution shall be
given. The resulting solution complies with the limit test
for arsenic.
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16. 13.Heavy metals
14.Iron
15.Chlorides
16.Sulphates
17.Non-volatile substances
18.Residual solvents: Determine by head-space gas
chromatography.
19.Microbial contamination: Determined by plate
count.
20.Bacterial Endotoxins
21.Sterility: It complies with the test for sterility.
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17. 22. Pyrogens
23. Sulphated ash: Not more than 0.1 per cent, determined on 2.0 g
24. Water
25. Loss on drying: Not more than 1.0 per cent, determined on 5.0 g
by drying in an oven at 100 to 105 .
26. Assay: Determine by liquid chromatography
• Test solution. Directions for preparing to be given
• Reference solution. – do –
• Chromatographic system:
• Details of the column,
• Mobile phase composition and flow rate,
• Detector and wavelength setting,
• Injection device (if any), and
• Any other detail.
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18. 27.Storage: Store at a temperature not exceeding 30 . If
the substance is sterile, store in a sterile, airtight,
tamper-proof container.
28.Labelling: Any special labelling statements specific
to the product is given.
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19. B. Inactive Ingredients other than Chemicals,
Drugs of Plant Origin
1. Title of the Monograph : Name in bold letters and font size
13pt.
2. Opening Statement: Must define the article
e.g. Activated Charcoal is obtained from vegetable matter by
suitable carbonisation processes intended to confer a high
adsorbing power.
3. Description, Identification and other tests, including
Assay
4. Relative density
5. Weight per ml
6. Refractive index
7. Melting point
8. Freezing point: Not less than xxx
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20. 9. Viscosity: x mPa.s to y mPa.s
10. Peroxide value, Acid value, Ester value
11. Unsaponi-fiable matter, Acetyl value, Hydroxyl value,
Saponi-fication value
12. Iodine value
13. Acidity
14. Foreign matter, Total ash, Ash insoluble in hydrochloric
acid
15. Storage
16. Labelling
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21. C. Dosage Forms
1. Title of the Monograph: Name in bold letters in
font size 13 pt
2. Description: For parenteral preparations information
shall be provided whether it is a solution, a
suspension, a dry powder
3. Content statement
4. Identification
5. Related substances/ Impurities: Tests for related
substances or impurities arising on manufacture or
storage of the dosage form shall be included.
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22. 6. Specific tests: For Aspirin Tablets: Salicylic acid.
7. Disintegration
8. Dissolution
9. Assay
10.Storage
11.Labelling
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23. D. Vaccines, Immunosera and Products
of Plant Origin
1. An opening statement that defines the preparation .
2. Production. The details of the method of producing
the product shall be described.
3. Identification.
4. Tests. Details of specific tests including sterility,
toxicity, potency or assay shall be given
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24. E. General Monographs on Dosage
Forms
The dosage forms for which General Monographs may be written are
as follows:
• Capsules
• Ear preparations
• Eye preparations
• Granules
• Liquids for oral use
• Nasal Preparations
• Parenteral preparations
• Oral powders
• Preparations for inhalation
• Creams and Ointments
• Rectal and vaginal preparations
• Tablets .
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25. The General Monographs shall be generally in three
sections:
A. General description or definition of the dosage form
and its different types.
B. Specific aspects of production that impact on the
quality of the product.
C. Tests to be done in addition to the ones set out in
the individual monographs.
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26. Reference:
• Indian Pharmacopoeia 6, “Guide to Formats” by
Indian Pharmacopoeial Commission.
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