Overview of Alkemists Labs Analytical Testing Resources

1. Alkemists Labs
The Analytical Testing Triad
“The Ingredient Authentication Experts”
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2. Overview
Founded in 1997 by Dr. Sidney Sudberg
Leading contract testing lab providing routine
and non-routine analytical solutions to raw
material suppliers and manufacturers
throughout the Natural Products Industry
Market segments supported:
 Dietary Supplements/Nutraceuticals
 Natural/Organic Foods, Livestock Feed and Pet Food
 Sports Nutrition Products/Ingredients
 Natural Personal Care/Cosmeceuticals
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3. Accreditations & Alliances
Accreditations
 ABC & AHPA Member
 cGMP Compliant
 FDA Registrant
Strategic Alliances
 Trout Lake Farms
 Strategic Sourcing
 Ingredient Identity
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4. Offerings
Expertise
 Botanical Identification and
Plant Authentication
 Microscopy/Macroscopy Service Line Distribution By Revenue
 HPLC (High Pressure Liquid 3%2%
Chromatography) 5% HPLC
TLC
 HP-TLC (Thin Layer 33% Microscopy
Chromatography) 15%
CRBs
 Botanical Investigation and Consulting
Finished Product De- Licensing
formulation services
 Composite Reference
Botanicals (CRBs)
42%
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5. Capabilities
Total Processing Capabilities
 Unique samples analyzed per week: 600-700
 Turn-around times: ~5-7 business days (<5 for
Identity by HPTLC)
 Ad-hocdevelopment work: 3 days (min) to 2
weeks (avg)
 Number of proprietary methods: ~1100
 Custom Botanical/Sample Database
 On-site Herbarium
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6. Ingredient Authentication Triad
Sample
Receipt
HP-TLC Microscopy HPLC
Sample Prep Microscopy Sample Prep
Method Dev Method Dev
or Validation Image or Validation
Logging
Sample Sample
Analysis Analysis
Data Review
Data Review Data Review
Database
Final Report 6
or CoA

7. Assuring Quality
HP-TLC in combination with Microscopy allow for ~80%
assurance in confirming sample identity and quality.
HP-TLC with Microscopy and HPLC allow for >99%
assurance in confirming sample identity, quality
and/or adulteration.
Extraction and Analytical Methods utilized are from a
variety of published and private sources:
 AOAC, ASTM, Food CODEX
 USP/NF, BP, JP and other pharmacopeia sources
 Proprietary methods (Client or Alkemists)
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8. Microscopy – Case Study
Black Cohosh species with Microscopy
Black Cohosh Yellow Cohosh Chinese Cohosh
brown suberized cells brown suberized cells brown suberized cells
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9. Microscopy – Case Study
Black Cohosh species with Microscopy
Black Cohosh Yellow Cohosh Chinese Cohosh
Parenchyma cells full of starch granules Parenchyma cells full of starch granules Parenchyma cells full of starch granules
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10. HP-TLC – Case Study
Black Cohosh species Differentiation by HP-TLC
Vanillin/H2SO4 Reagent  110° C 5 min  visible light  UV 365 nm
Actaea racemosa L. [Ranunculaceae]
Lanes 2(2µl), 3(4µl) (FA10604AHP) Actaea racemosa
2(2µ 3(4µ
Lanes 6(4µl), 7(2µl) (VR32903SWH) Actaea heracleifolia / Sheng Ma (root) Lane 1(3µl)
6(4µ 7(2µ 1(3µ
actein, Lane 8(3µl) 26-deoxyactein ~0.1% in CH3OH, from Chromadex
actein, 8(3µ 26-
toluene: ethyl formate: formic acid [5/3/2]
formate:
Silica gel 60, F254, 10 x 10 cm HPTLC plates
Reference Source: American Herbal Pharmacopoeia & Therapeutic Compendium
Compendium
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11. HP-TLC – Case Study
Black Cohosh species with HP-TLC
Lanes 5 – 8, 11 - 14 & 17: UV 254 nm
Actaea racemosa
Lanes 2 & 3:
Actaea heraclefolia
Lane 3:
Actaea podocarpa
Lane 12:
Actaea pachypoda
Lane 16:
UV 365 nm
Actaea rubra
Lanes 1 & 10: actein
Lanes 9 & 18: 26-deoxy actein
26-
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Silica gel 60, F254, 20 x 10 cm HPTLC plates

12. HPLC – CofA Case Study
Ginkgo
extract
analysis with
HPLC - UV
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13. Regulations
Identity Testing Requirements
 All ingredients must be identified
 Dietary Supplement GMPs - 21 CFR Part 11
 TLC & Microscopy at a minimum
 Microscopy to identify chemically inert
ingredients with non-detectable attributes
 TLC give full chemical spectrum fingerprint
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14. Our Clients
Have Varying Needs
 Needs vary greatly depending on product type, timing, in-house
resources and size of company
 AP works with large and small companies – can provide critical
consultancy on optimal testing practices and needs
Typical Services Sought
 Botanical Identification/Authentication needs
 Product/Ingredient evaluation (for sourcing support) and equivalency
determination between lots
 Investigative concerns of adulterations/contamination
 De-formulating or Reverse Engineering finished products
 Maintaining quality of starting materials or intermediates as part of
their Manufacturing Quality Controls/Systems
 Contract research to develop and/or validate methodologies and
define Control Parameters that can be transferred back in-house
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15. Alkemists Solutions I
Standard Operating Protocols
 Well defined procedures covering all steps from Sample Receipt
to Document Control and Final Reporting
Compliant Laboratory Practices
 Documentation of analytical instruments, sample and inventory
management, health and safety, and disposal of waste materials,
training and study directors
Quality Assurance
 Separate review of data and documentation to ensure accuracy
and reliability of results
Product Stability Support (Shelf-life determination)
 Study design, analysis and computation to determine shelf life
and support label claims
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16. Alkemists Solutions II
Method Development/Validation Experience
 Industry recognized experts with a large variety of
botanicals ingredients and diverse formulations
De-formulation experience
 Expertise in strategically investigating novel/proprietary
products with solid, semi-solid and liquid formulations
Herbarium & Monograph Library
 >800 categorized botanicals, plant extracts and plant
monographs on-site
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17. Alkemists Solutions III
Feasibility Studies (R&D)
 Contract research at a fixed amount of time and cost,
in increments of 40 or 80 billable hours to identify any
unknowns are not well-defined study parameters
 Essential to understand the roadmap of what steps work
and do not work, so as to minimize future duplication of
research and development efforts
 Minimizes overall risk of a Client overpaying for
resources not yielding desired results and the Lab over
committing resources to deliver desired results
 Method development work is necessary to achieve a
method that can be qualified and/or validated
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18. Alkemists Solutions IV
Method Development & Validation
 MethodValidation: the process to provide
evidence that the method does what it is
intended to do, accurately, reliably &
reproducibly.
 Method Qualification is just the phase one of a
formal validation, which omits “intermediate
precision” and “method stability.”
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