Stability of reserpine injections and tablets submitted by U.S. hospitals.
The stability of reserpine injections and tablets that had been stored in hospital pharmacies across the United States was studied. Through a voluntary FDA drug stability program, all hospital pharmacies in the United States were asked to complete a response card indicating information about the reserpine injections and tablets they had in stock. Based on the responses, FDA selected 93 samples of reserpine injections and 51 samples of reserpine tablets. The samples of injections were subjected to tests for identification, pH, presence of other alkaloids, presence of 3,4-dehydroreserpine, and strength. All samples of reserpine injections met USP requirements. Two samples of reserpine tablets representing one lot each from two manufacturers failed to meet USP requirements for content uniformity. Reserpine injections and tablets appear to be stable under actual marketplace conditions.
D002851:Chromatography, High Pressure Liquid; D002855:Chromatography, Thin Layer; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007267:Injections; D010607:Pharmacy Service, Hospital; D012110:Reserpine / Q000032:analysis* / Q000592:standards; D012995:Solubility; D012996:Solutions; D013607:Tablets; D014481:United States; D014486:United States Food and Drug Administration
D012996:Solutions; D013607:Tablets; D012110:Reserpine