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Alkemists - Analytical Services Triad


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Overview of Alkemists Labs Analytical Testing Resources

Overview of Alkemists Labs Analytical Testing Resources

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  • 1. Alkemists Labs The Analytical Testing Triad “The Ingredient Authentication Experts” 1
  • 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 2
  • 3. Accreditations & Alliances Accreditations  ABC & AHPA Member  cGMP Compliant  FDA Registrant Strategic Alliances  Trout Lake Farms  Strategic Sourcing  Ingredient Identity 3
  • 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% 4
  • 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 5
  • 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) 7
  • 8. Microscopy – Case Study Black Cohosh species with Microscopy Black Cohosh Yellow Cohosh Chinese Cohosh brown suberized cells brown suberized cells brown suberized cells 8
  • 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 9
  • 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 10
  • 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- 11 Silica gel 60, F254, 20 x 10 cm HPTLC plates
  • 12. HPLC – CofA Case Study Ginkgo extract analysis with HPLC - UV 12
  • 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 13
  • 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 14
  • 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 15
  • 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 16
  • 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 17
  • 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.” 18
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