At the heart of regulatory compliance and the delivery of safe, effective botanical products is one fundamental question: identity. Plant chemistry is inherently complex and further complicated by modern production techniques. Adulteration with the wrong plant or plant part remains far too common. Proper botanical identification is both essential and required by 21 CFR Part 111.
Watch how a sample moves through our lab to provide reliable, defensible data:
Fit for Purpose
Many plants have close relatives that look and smell very much alike. Sometimes they have similar actions, other times very different ones, occasionally one is safe and effective, but the other is toxic. Your product label is required to be specific and accurate, so you need to know the genus and species on any plant you plan to buy or sell. Many faster, cheaper methods can’t distinguish between what you want and what you don’t. We use the best method for your needs.
We have one of the industry’s largest collection of analyzed & authenticated medicinal botanical and fungi specimens representing ~2,000 species.
~20,000 verifiedspecimens spanning over 30 years of global botanical commerce provide us with unprecedented insights into the botanical supply chain.
A critical reference for identity testing, enabling accurate comparisons regardless of geography or processing including confounding species, plant parts and known adulterants.
Composite Reference Materials
For companies with in-house lab capabilities, we provide custom blends of verified botanicals. These reference materials are composited from multiple sources representing seasonal & regional variabilities.
Regulatory requirements for finished product identity testing is similar to the raw materials, but this is often overlooked. There are several approaches for testing identity in finished products. Our enterprise can help determine the best approach for your material.
Our Tools & Methods
Microscopy
Microscopy is one of the oldest and still most effective techniques employed to assess identity and quality of botanicals. It often times is able to detect adulterants and contamination including fillers, extracts, and incorrect plant parts. This preferred technique is applicable to crude raw botanicals from powdered to whole form.
High Performance Thin-Layer Chromatography assesses the identity and quality of botanical and fungi materials, detecting potential adulterants and incorrect plant parts. It is applicable to crude raw botanicals from powdered to whole form, extract (powdered or liquid), and finished product/blends. HPTLC is the preferred technique worldwide.
The level of expertise demonstrated by the lab you’ve chosen speaks volumes about your commitment to accurate identity testing. The correct analytical technique needs to be properly chosen and matched to each individual test sample so that botanical species and plant part can be confirmed in compliance with regulatory requirements.
Alkemist Labs is ISO/IEC 17025 accredited by A2LA
Our scope covers dietary supplement and botanical identification by HPTLC and Microscopy
Our dedicated account managers provide personalized service
Our technical team is always accessible to discuss your report