Chiral drugs: the FDA perspective on manufacturing and control.
On 27 May 1992, the FDA announced the availability of a policy statement on the development of stereoisomeric drugs. This statement has significant implications for the chemist who is working on the development and validation of analytical controls for chiral drug substances and products. The testing of the bulk drug, the manufacturing of the finished product, the design of stability testing protocols, and the labelling of the drug must all take the chirality of the active ingredient into consideration.
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Division of Anti-Infective Drug Products, Rockville, MD 20857.
D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D017277:Drug Approval; D004345:Drug Industry; D004335:Drug and Narcotic Control; D011786:Quality Control; D013237:Stereoisomerism; D014481:United States; D014486:United States Food and Drug Administration