Contract Laboratory received a request from a pharmaceutical manufacturer that needed outsourcing of it’s testing to an analytical chemistry laboratory for Water Activity testing for Schedule II Pharmaceutical Finished Product. Schedule II Pharmaceuticals are part of a classification system within the United States Controlled Substances Act or CSA.
The Controlled Substance Act was passed as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. It has schedules for the control of 5 classifications of drugs. The US Food and Drug Administration and the US Drug Enforcement Administration classify drugs within these schedules.
The schedules are based on their potential for abuse, accepted medical use, and accepted safety under medical supervision. Substances in Schedule I have a high potential for abuse, no accredited medical use, and a lack of accepted safety. From Schedules II to V, substances decrease in potential for abuse. These schedules are maintained for the control of the drugs and require strict recordkeeping or approval to handle drugs of different classifications.
Contract Laboratory has helped manufacturers of various schedules of drugs outsource their testing and research to laboratories. Below are examples how Contract Laboratory helped in the outsourcing of Scheduled drugs. If your pharmaceutical company needs to outsource it’s laboratory research, testing or analysis, Submit Laboratory Test Request or call 1-855-377-6821.
|New York or New Jersey analytical chemistry laboratory needed for Water Activity testing for Schedule II Pharmaceutical Finished ProductFlorida DEA Pharmaceutical Laboratory needed for Schedule I Controlled Substance Testing. Laboratory must have DEA License to test Schedule I Controlled Substances
Southern California Consumer Products Certification Laboratory needed for certification testing of incense product for the following banned substances. DEA Temporary (Final Order Mar. 2011) and Permanent Schedule I Cannabinoids List: JWH-018 (Same as AM-678); JWH-018 N-(3methylbutyl) isomer JWH-0
FDA/GMP Analytical Chemistry Laboratory needed for testing of a DEA Schedule 1 drug. API/ Aerosol/ Product/ HPLC impurities
FDA GMP and GLP laboratory with DEA Schedule II license needed for LC/MS/MS analytical method validation test method for routine quantitation of a single organic impurity in the range of 1 – 10 ppm. Separation method already developed.