Overcoming Labryinthine US Regulations
By Angelo DePalma, PhD
All analytical sciences rely on reference standards—standardized, punctiliously prepared and characterized samples—to guarantee the veracity of their results but even more importantly, of their methodology. Cannabis is a complex botanical capable of generating numerous downstream products, each with unique critical quality attributes. And, as a botanical, it is itself an extremely complex matrix.
“My impression is that most people use the terms ‘reference standard’ and ‘reference material’ interchangeably, but they’re not the same thing,” says Dr. Sid Sudberg, founder of Alkemist Labs (Garden Grove, CA) and technical advisor for the American Herbal Pharmacopoeia.
According to Sudberg, a reference material is a substance, botanical, or a multi-component preparation from the plant, whereas reference standards are single chemical compounds or pure substances of known concentrations, which may be directly compared with values from samples after constructing an appropriate concentration graph. “The taxonomically identified plant in its flowering state is considered the gold standard of botanical identification and will nearly always suffice as a valid reference material for botanicals,” Sudberg adds. “Since flowering plants are not always available, we rely on several different levels of authentication.”
Variations on the authentication process commonly used to create valid botanical reference materials require identification methods with reasonably high specificity, along with a reasonable number of closely-related species and/or plant parts, so as to rule out a pure specimen from a closely related species. [Read More @ Lab Manager]