Herbal product analysis: are analytical standards your achilles heel?

In controlling the supply chain of botanical raw materials, extracts and other dietary ingredients, there are different challenges that must be addressed compared to other industries, especially in the traceability and sustainability of plant sources. However, there are also universal principles that may apply: testing of starting materials, intermediates and finished products for identity, contamination and potency.

Among many testing techniques, the determination and quantification of chemical constituents of herbs or herbal products is of tremendous value beyond meeting regulatory requirements. Chromatographic techniques have been available for years to address these needs, whether the purpose is material identification, potency assurance, or the detection of contamination and adulteration.

Because the results of chromatographic techniques are calculated directly against the reference standards chosen, these reference standards have direct impact on the ability to accurately assess the safety, quality, and potency of the raw materials and finished products that have been tested. It is critical that companies understand and incorporate reference standards as part of their increased commitment to valid, fit for purpose product testing as required by 21CFR 111.320 (a-b).

As industry companies work to develop unassailable testing programs, and reference standards are increasingly understood to be a vital component of herbal product testing, the sourcing of quality reference standards is as important as increased commitment to sourcing quality ingredients.