Steven Yeager, laboratory and quality control manager of Eugene, OR-based Mountain Rose Herbs, is one of the speakers at the upcoming workshop being put on jointly by the American Herbal Pharmacopoeia and the American Herbal Products Association. Roy Upton, founder of AHP and Majed Sharaf, PhD, AHPA’s chief scientific officer, will also present.
“The class is full, and I think that is a positive step,” Yeager said. “I think we are finding that we need more plant scientists, more herbal knowledge within the industry.”
Titled “Botanical, macroscopic and organoleptic assessment of herbal ingredients for cGMP compliance,” the two-day session will take place in mid June at Portland State University in Portland, OR. The two days aim to provide a detailed look at botanical, macroscopic, and organoleptic identification methods; quality assessment techniques and terminology; and demonstrate how these techniques are used to evaluate crude plant parts in a scientifically valid manner.
Addressing a possible Achilles heel
Identification of botanicals has become a hot button issue in recent months in the wake of the NYAG affair. Many experts in the industry have criticized NY AG Eric Schneiderman for basing his actions on scientifically shaky principles and for holding up DNA barcoding as a gold-standard, one-and-done technology in botanical identification. Nevertheless, they admit that the white hot glare of publicity has exposed possible weaknesses within the industry on the identification end of the spectrum, where all too many lots of incoming material are taken more or less at face value based on a certificate of analysis.
Mountain Rose Herbs sources dozens of different botanicals from a wide variety of sources, Yeager said. His company’s experience mirrors that of many in the industry, where a variety of approaches must be taken to identify with confidence incoming material.
“We use a variety of methods depending on how we receive the product. If it is a whole form we can use more traditional botanical methods. For other forms we rely principally on thin layer chromatography,” Yeager said.
Focus on traditional botany
The workshop will focus on botanical identification using traditional botany as the basis for which incoming materials are identified. In recent years there has been a resurgence of interest in macroscopic, organoleptic analysis of crude materials as being among the most most rapid, accurate, cost-effective, and environmentally sound of all the analytical technologies.
“There is no one method fits all approach. In thin layer chromatography you are not always going to see an exact fingerprint. There could be a number of reasons for that, including soil conditions in which the botanical was grown and time of harvest,” he said.
The workshop will cover the following areas:
- Botanical identity current good manufacturing practice (cGMP) compliance requirements
- Strengths and weaknesses of various analytical technologies (botanical, morphological, microscopic, chemical, DNA)
- Botanical terminology and botanical identification of plant materials
- Language of botanical pharmacognosy and organoleptics
- Terminology and assessment techniques for roots, leaves, stems, barks, flowers, fruits, seeds
- Developing and documenting macroscopic and organoleptic assessments in a scientifically valid manner
- Common and uncommon botanical adulterants: how to detect and how to avoid them; Sourcing of botanical reference materials and developing internal standards.
Yeager said participants can use the information garnered in the workshop to bolster their own botanical ID programs. These will need to be tailored to each company’s specific requirements to build an orthogonal approach to ID specifications, and the GMP rules are written in such a way to encourage companies to do this.
“If you are going to have a successful ID program you are going to want to employ within your financial means those methods that give you the most confidence in the result. Plants can have different chemotypes depending on where they are growing. A company might have to come up with their own reference material if a botanical which they might have grown on their own farm doesn’t match the reference standard they got from ChromaDex or Alkemist,” Yeager said.
“I think there is a lot of integrity in the industry. Most people want to have the right ingredient in the bottle,” he said.