Overcoming Labryinthine US Regulations

By Angelo DePalma, PhD

All analytical sciences depend on reference requirements—standardized, punctiliously ready and characterised samples—to ensure the veracity of their outcomes however much more importantly, of their methodology. Cannabis is a fancy botanical able to producing quite a few downstream merchandise, every with distinctive essential high quality attributes. And, as a botanical, it’s itself an especially complicated 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, founding father of Alkemist Labs (Garden Grove, CA) and technical advisor for the American Herbal Pharmacopoeia.

According to Sudberg, a reference materials is a substance, botanical, or a multi-component preparation from the plant, whereas reference requirements are single chemical compounds or pure substances of recognized concentrations, which can be straight in contrast with values from samples after setting up an acceptable focus 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 provides. “Since flowering plants are not always available, we rely on several different levels of authentication.”

Variations on the authentication course of generally used to create legitimate botanical reference supplies require identification strategies with moderately excessive specificity, together with an inexpensive variety of closely-related species and/or plant components, in order to rule out a pure specimen from a intently associated species.  [Read More @ Lab Manager]

 



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