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Investigation of the Impurities in Dronabinol Samples by LCMS

Authors: Huahua Jian, Isil Dilek, Uma Sreenivasan, Kenan Yaser
Presented at Pittcon, Orlando, FL, March 2010

Abstract
Tetrahydrocannabinol (D9-THC) is a psychoactive substance found in cannabis plants (“Medical Marijuana”). Synthetic D9-THC, also called Dronabinol, was approved by US FDA as a drug to treat pain, anorexia and nausea related to chemotherapy and other disorders.  Dronabinol is a light yellow to amber glassy material. It is sensitive to light, heat, and oxygen (air). The impurities in commercial Dronabinol drugs may come from either the synthetic process or through product degradation.  Identification of these impurities is required by FDA and ICH guidelines for pharmaceuticals.  A comparison of impurities in Dronabinol from a variety of sources was performed by HPLC and LCMS.

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