Cannabis-From herbal into a dosage form
Analytical considerations and lesson learned regarding the determination of active cannabinoids

Dr. Revital Rapoport, Head of Chemistry Division, Aminolab laboratories LTD., Ness Ziona, Israel

The therapeutic characteristic of Cannabis has been known for years . However , along the last 30 years , the use of cannabis as medicine has not been rigorously tested due to production and governmental restrictions, in many countries resulting in limited clinical research to define the safety and efficacy of using cannabis to treat diseases. Now as regulation is changing , the manufacturing of cannabis products from API through the final dosage forms requires GMP conditions and accordingly , reliable fully validated analytical method to determine the assay of the active components. Aminolab laboratories has developed a HPLC method that enables to determine 8 cannabinoids. One of the main operational difficulties is the availability of reference standards. THC is the chemical responsible for most of marijuana's psychological effects, therefore the availability of THC standard is very restricted. Hence it became operationally complicated to support a growing demand of analyses and support our customers at a very challenging time frames. Hence, Aminolab decided to adopt the approach of using response factors and to calculate the Assay vs. one available non – narcotic standard- CBD. Aminolab has determined all the response factors of the cannabinoids using available reference analytical standard and compared to that of CBD. The factors relative to CBD were between the range of 0.76-1.50. However even after using these values the validation failed the strict requirements of intermediate precision (A comparison of results obtained by two different analysts on different days using different instruments) . By deep spectral and chemical evaluation it was found why the method is insufficiently robust after taking into account response factors. Corrective action has been established and the method was modified. The evaluation and the lesson learned will be covered in details along the lecture.

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Biography

Dr. Rapoport has completed her Ph.D. in Biochemistry in the Hebrew University of Jerusalem in 1994. Then she joined Teva Pharmaceutical Industries analytical R&D in Israel . Since then, she has gained a large professional experience in the pharma industries. Over 23 years in Teva she fulfilled verity of rolls. As the Head of Teva API QC laboratories she supervised more than 20 QC Teva Laboratories all over the globe demanding the highest GMP standards . In 2013 she was nominated as a global site quality head of Teva API America's Operation and in 2015 nominated as a site quality head of the largest pharma site of Teva in Kfar Saba Israel. She joined Aminolab laboratories in 2017 leading a strategy of being pioneers in Cannabis tests and methods development, by implementing the pharma and Aminolab combined excellence and innovation. As the head of the chemistry division in Aminolab she fully supports , by variety of tests, the medical Cannabis industry in Israel with the growing regulatory requirements.