2017 Company Profiles: Alkemist Labs
Alkemist Labs: Identify, Analyze, Verify
As a pioneer in natural products testing, Alkemist Labs helps companies achieve and maintain quality products and cGMP (current good manufacturing practice) compliance. Alkemist Labs, an industry recognized leader established in 1997 and celebrating its 20th anniversary this year, is a contract testing laboratory that renders comprehensive analytical testing solutions to its clients in the Food & Beverage, Nutraceutical and Cosmeceutical Industries to meet its product safety, transportation and quality guidelines. Testing natural products is all the company does, and it does it extraordinarily well.
The company’s mission to bring transparency to all areas of natural products industry testing includes education tools designed to demystify testing and help companies obtain accurate results to support regulatory compliance and illustrate their quality commitment to consumers.
Alkemist Labs specializes in routine QC/Compendial testing, method development and validation/verification services, and dedicated research services. The company offers high throughput HPTLC analysis for botanical ingredient identity testing of whole herbs and plant extracts with a standard five-business day turn-around time. In combination with HPLC, Microscopy and its on-site Herbarium, Alkemist Labs offers the most reliable technical support and the highest quality services.
Alkemist Labs has ISO 17025 accreditation by the American Association for Laboratory Accreditation (A2LA). The Lab has also met the AOAC Analytical Laboratory Accreditation Criteria Committee (ALACC) guidelines that are newly revised to include criteria specific to testing dietary supplements. Both of these independent benchmarks further substantiate Alkemist Labs stated commitment to the highest standards of testing.
The ISO 17025 accreditation demonstrates that Alkemist Labs meets managerial and technical quality benchmarks as required by the International Organization for Standardization ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories for the tests performed within Alkemist’s scope. This certification meets the A2LA P112 Flexible Scope Policy, which states: “There are circumstances in which a laboratory performs testing activities for which it can not identify either standard test methods prepared by national, international or professional standards writing bodies or in-house developed non-standard methods on their fixed scope of accreditation. These situations usually arise when the laboratory requires flexibility in allowing for changes in the matrices within a product area (flexibility concerning object/matrix/sample) or with respect to parameters (flexibility concerning parameters/components/analytes),” which allows the lab discretion to adapt method parameters to a wide variety of preparations and products to best meet customer needs.
Specific services include:
Identify: Botanical Microscopy, HPTLC/MS and HPLC fingerprinting, Next Generation DNA Sequencing, Composite Reference Botanicals (CRBs)
Analyze: HPLC, GC, UV-Vis, UPLC/MS & Wet Chemistry
Verify: The FDA (U.S. Food and Drug Administration) requires brands to able to prove their label claims using scientifically valid methods. Alkemist Labs offers custom verification and validation services for its clients’ unique finished products and their ingredients.
Phytochemical & Botanical Reference Materials
Alkemist Labs reference material offerings include Phytochemical Reference Standards manufactured by Extrasynthese, Lyon, France and Botanical Reference Materials developed internally as well as by the American Herbal Pharmacopoeia (AHP).
Phytochemical reference standards are highly purified substances used in natural product testing. The company’s proper selection and use directly impacts the ability to assess the safety, quality and potency of both raw materials and finished products. Alkemist Labs is the exclusive North American distributor for Extrasynthese, and offers its full line of phytochemical standards for on-line search and purchase through its e-commerce website.
Botanical reference materials are plant biomass materials that have been authenticated through a variety of analytical techniques such as macroscopic verification, microscopic identification and HPTLC. Botanical reference materials are a critical tool that helps the industry meet cGMP ingredient identification requirements for botanical raw materials. With the combined catalogs of Alkemist and AHP offered through the Alkemist e-commerce website, customers have a complete library of the top used herbs in commerce.
Alkemist Labs holds memberships and is active in multiple trade associations and industry groups: ABC, AHPA, CRN and UNPA. It also devotes significant time working with technical organizations such as AOAC, USP and AHP.