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Alkemists Labs Alkemists Labs The Analytical Testing TriadThe Analytical Testing Triad

“The Ingredient Authentication Experts”

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OverviewOverviewFounded in 1997 by Dr. Sidney Sudberg Founded in 1997 by Dr. Sidney Sudberg Leading Leading ccontract testing labontract testing lab providing routine providing routine

and nonand non--routine analytical solutions to raw routine analytical solutions to raw material suppliers and manufacturers material suppliers and manufacturers throughout the Natural Products Industrythroughout the Natural Products Industry

Market segments supported:Market segments supported: Dietary Supplements/Dietary Supplements/NutraceuticalsNutraceuticals Natural/Organic Foods, Livestock Feed and Pet FoodNatural/Organic Foods, Livestock Feed and Pet Food Sports Nutrition Products/IngredientsSports Nutrition Products/Ingredients Natural Personal Care/Natural Personal Care/CosmeceuticalsCosmeceuticals

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Accreditations & AlliancesAccreditations & Alliances

AccreditationsAccreditations ABC & AHPA MemberABC & AHPA Member cGMPcGMP CompliantCompliant FDA RegistrantFDA Registrant

Strategic AlliancesStrategic Alliances Trout Lake FarmsTrout Lake Farms Strategic SourcingStrategic Sourcing Ingredient IdentityIngredient Identity

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OfferingsOfferingsExpertiseExpertise

Botanical Identification and Botanical Identification and Plant AuthenticationPlant Authentication

Microscopy/Microscopy/MacroscopyMacroscopy HPLC (High Pressure Liquid HPLC (High Pressure Liquid

Chromatography)Chromatography) HPHP--TLC (Thin Layer TLC (Thin Layer

Chromatography)Chromatography) Botanical Investigation and Botanical Investigation and

Finished Product DeFinished Product De--formulation servicesformulation services

Composite Reference Composite Reference Botanicals (Botanicals (CRBsCRBs))

Service Line Distribution By Revenue

33%

42%

15%

5% 3%2% HPLCTLCMicroscopyCRBsConsultingLicensing

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CapabilitiesCapabilities

Total Processing CapabilitiesTotal Processing Capabilities Unique samples analyzed per week: 600Unique samples analyzed per week: 600--700700 TurnTurn--around times: ~5around times: ~5--7 business days (<5 for 7 business days (<5 for

Identity by HPTLC)Identity by HPTLC) AdAd--hoc development work: 3 days (min) to 2 hoc development work: 3 days (min) to 2

weeks (weeks (avgavg)) Number of proprietary methods: ~1100Number of proprietary methods: ~1100Custom Botanical/Sample DatabaseCustom Botanical/Sample DatabaseOnOn--site Herbariumsite Herbarium

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HPHP--TLCTLC

Ingredient Authentication TriadIngredient Authentication Triad

Final ReportFinal Reportor or CoACoA

Sample Sample ReceiptReceipt

Method DevMethod Devor Validationor Validation

HPLCHPLCMicroscopyMicroscopyMicroscopyMicroscopy

Sample Sample AnalysisAnalysis

Sample Sample AnalysisAnalysis

Data ReviewData Review

Image Image LoggingLogging

DatabaseDatabase

Sample PrepSample Prep

Method DevMethod Devor Validationor Validation

Sample PrepSample Prep

Data ReviewData ReviewData ReviewData Review

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Assuring QualityAssuring QualityHPHP--TLC in combination with Microscopy allow for ~80% TLC in combination with Microscopy allow for ~80%

assuranceassurance in confirming sample identity and quality. in confirming sample identity and quality.

HPHP--TLC with Microscopy and HPLC allow for >99% TLC with Microscopy and HPLC allow for >99% assuranceassurance in confirming sample identity, quality in confirming sample identity, quality and/or adulteration.and/or adulteration.

Extraction and Analytical Methods utilized are from a Extraction and Analytical Methods utilized are from a variety of published and private sources:variety of published and private sources:

AOAC, ASTM, Food CODEXAOAC, ASTM, Food CODEX

USP/NF, BP, JP and other pharmacopeia sourcesUSP/NF, BP, JP and other pharmacopeia sources

Proprietary methods (Client or Alkemists)Proprietary methods (Client or Alkemists)

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Microscopy Microscopy –– Case StudyCase StudyBlack Black CohoshCohosh species with Microscopyspecies with Microscopy

Black CohoshBlack Cohosh Yellow Yellow CohoshCohosh Chinese CohoshChinese Cohosh

brown suberized cellsbrown suberized cells brown suberized cellsbrown suberized cells brown suberized cells brown suberized cells

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Microscopy Microscopy –– Case StudyCase StudyBlack Black CohoshCohosh species with Microscopyspecies with Microscopy

Parenchyma cells full of starch granulesParenchyma cells full of starch granules Parenchyma cells full of starch granulesParenchyma cells full of starch granules Parenchyma cells full of starch granulesParenchyma cells full of starch granules

Black CohoshBlack Cohosh Yellow Yellow CohoshCohosh Chinese CohoshChinese Cohosh

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HPHP--TLC TLC –– Case StudyCase StudyBlack Black CohoshCohosh species Differentiation by HPspecies Differentiation by HP--TLCTLC

ActaeaActaea racemosaracemosa L. [L. [RanunculaceaeRanunculaceae]]

Vanillin/H2SO4 Reagent 110° C 5 min visible light UV 365 nm

Lanes 2(2Lanes 2(2µµl), 3(4l), 3(4µµl) (FA10604AHP) l) (FA10604AHP) ActaeaActaea racemosaracemosaLanes 6(4Lanes 6(4µµl), 7(2l), 7(2µµl) (VR32903SWH) l) (VR32903SWH) ActaeaActaea heracleifoliaheracleifolia / / ShengSheng Ma (root) Lane 1(3Ma (root) Lane 1(3µµl) l) acteinactein, Lane 8(3, Lane 8(3µµl) 26l) 26--deoxyactein ~0.1% in CH3OH, from deoxyactein ~0.1% in CH3OH, from ChromadexChromadextoluene: ethyl toluene: ethyl formateformate: formic acid [5/3/2] : formic acid [5/3/2] Silica gel 60, F254, 10 x 10 cm HPTLC platesSilica gel 60, F254, 10 x 10 cm HPTLC platesReference Source: American Herbal Pharmacopoeia & Therapeutic CoReference Source: American Herbal Pharmacopoeia & Therapeutic Compendiummpendium

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Black Black CohoshCohosh species with HPspecies with HP--TLCTLC

HPHP--TLC TLC –– Case StudyCase Study

Lanes 5 Lanes 5 –– 8, 11 8, 11 -- 14 & 17:14 & 17:ActaeaActaea racemosaracemosa

Lanes 2 & 3:Lanes 2 & 3:ActaeaActaea heraclefoliaheraclefolia

Lane 3: Lane 3: ActaeaActaea podocarpapodocarpa

Lane 12:Lane 12:ActaeaActaea pachypodapachypoda

Lane 16:Lane 16:ActaeaActaea rubrarubra

Lanes 1 & 10: Lanes 1 & 10: acteinactein

Lanes 9 & 18: 26Lanes 9 & 18: 26--deoxy deoxy acteinactein

Silica gel 60, FSilica gel 60, F254254, 20 x 10 cm HPTLC plates, 20 x 10 cm HPTLC plates

UV 254 nm

UV 365 nm

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Ginkgo Ginkgo extract extract analysis with analysis with HPLC HPLC -- UVUV

HPLC HPLC –– CofACofA Case StudyCase Study

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RegulationsRegulations

Identity Testing RequirementsIdentity Testing Requirements All ingredients must be identifiedAll ingredients must be identified

Dietary Supplement Dietary Supplement GMPsGMPs -- 21 CFR Part 1121 CFR Part 11

TLC & Microscopy at a minimumTLC & Microscopy at a minimum

Microscopy to identify chemically inert Microscopy to identify chemically inert ingredients with noningredients with non--detectable attributesdetectable attributes

TLC give full chemical spectrum fingerprintTLC give full chemical spectrum fingerprint

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Our ClientsOur ClientsHave Varying NeedsHave Varying Needs

Needs vary greatly depending on product type, timing, inNeeds vary greatly depending on product type, timing, in--house house resources and size of companyresources and size of company

AP works with large and small companies AP works with large and small companies –– can provide critical can provide critical consultancy on optimal testing practices and needsconsultancy on optimal testing practices and needs

Typical Services SoughtTypical Services Sought Botanical Identification/Authentication needsBotanical Identification/Authentication needs Product/Ingredient evaluation (for sourcing support) and equivalProduct/Ingredient evaluation (for sourcing support) and equivalency ency

determination between lotsdetermination between lots Investigative concerns of adulterations/contaminationInvestigative concerns of adulterations/contamination DeDe--formulating or Reverse Engineering finished productsformulating or Reverse Engineering finished products Maintaining quality of starting materials or intermediates as paMaintaining quality of starting materials or intermediates as part of rt of

their Manufacturing Quality Controls/Systemstheir Manufacturing Quality Controls/Systems Contract research to develop and/or validate methodologies and Contract research to develop and/or validate methodologies and

define Control Parameters that can be transferred back indefine Control Parameters that can be transferred back in--househouse

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Alkemists Solutions IAlkemists Solutions IStandard Operating ProtocolsStandard Operating Protocols

Well defined procedures covering all steps from Sample Receipt Well defined procedures covering all steps from Sample Receipt to Document Control and Final Reportingto Document Control and Final Reporting

Compliant Laboratory PracticesCompliant Laboratory Practices Documentation of analytical instruments, sample and inventory Documentation of analytical instruments, sample and inventory

management, health and safety, and disposal of waste materials, management, health and safety, and disposal of waste materials, training and study directorstraining and study directors

Quality AssuranceQuality Assurance Separate review of data and documentation to ensure accuracy Separate review of data and documentation to ensure accuracy

and reliability of resultsand reliability of results

Product Stability Support (ShelfProduct Stability Support (Shelf--life determination)life determination) Study design, analysis and computation to determine shelf life Study design, analysis and computation to determine shelf life

and support label claimsand support label claims

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Alkemists Solutions IIAlkemists Solutions IIMethod Development/Validation ExperienceMethod Development/Validation Experience

Industry recognized experts with a large variety of Industry recognized experts with a large variety of botanicals ingredients and diverse formulationsbotanicals ingredients and diverse formulations

DeDe--formulation experienceformulation experience Expertise in strategically investigating novel/proprietary Expertise in strategically investigating novel/proprietary

products with solid, semiproducts with solid, semi--solid and liquid formulations solid and liquid formulations

Herbarium & Monograph LibraryHerbarium & Monograph Library >800 categorized botanicals, plant extracts and plant >800 categorized botanicals, plant extracts and plant

monographs monographs onon--sitesite

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Alkemists Solutions IIIAlkemists Solutions IIIFeasibility Studies (R&D)Feasibility Studies (R&D)

Contract research at a fixed amount of time and cost, Contract research at a fixed amount of time and cost, in increments of 40 or 80 billable hours to identify any in increments of 40 or 80 billable hours to identify any unknowns are not wellunknowns are not well--defined study parametersdefined study parameters

Essential to understand the roadmap of what steps work Essential to understand the roadmap of what steps work and do not work, so as to minimize future duplication of and do not work, so as to minimize future duplication of research and development research and development efforts efforts

Minimizes overall risk of a Client overpaying for Minimizes overall risk of a Client overpaying for resources not yielding desired results and the Lab over resources not yielding desired results and the Lab over committing resources to deliver desired resultscommitting resources to deliver desired results

Method development work is Method development work is necessarynecessary to achieve a to achieve a method that can be qualified and/or validatedmethod that can be qualified and/or validated

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Alkemists Solutions IVAlkemists Solutions IV

Method Development & ValidationMethod Development & ValidationMethod ValidationMethod Validation: the process to provide : the process to provide

evidence that the method does what it is evidence that the method does what it is intended to do, accurately, reliably & intended to do, accurately, reliably & reproducibly.reproducibly.

Method QualificationMethod Qualification is just the phase one of a is just the phase one of a formal validation, which omits formal validation, which omits ““intermediate intermediate precisionprecision”” and and ““method stability.method stability.””

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