Inactive

The U.S. Food and Drug Administration (FDA), New York Laboratory Medical Products in the Office of Regulatory Science, Office of Medical Products, Tobacco, and Specialty Laboratory Operations, located... The U.S. Food and Drug Administration (FDA), New York Laboratory Medical Products in the Office of Regulatory Science, Office of Medical Products, Tobacco, and Specialty Laboratory Operations, located at 158-15 Liberty Avenue, Jamaica, NY, 11433.The system in use needs to maintain cGMP/cGLP, ISO/IEC 17025-2005, ISO 9001:2008, and 21 CFR 11 standards for use as analytical equipment under the current accreditation. The dissolution system is used to evaluate the rate and extent that a compound forms a solution, typically, for drug samples using specific protocols and methods established by USP monographs. Dissolution testing is performed with apparatus described in General Chapter <711> Dissolution.