ABSTRACT
An optimum freeze-drying cycle was developed for use with industrial equipment in the processing in vials of a product degraded by traces of moisture. The relative humidity of the headspace gas of the vials, which contained only 5 microgram of active ingredient, was monitored by a GC method and was then correlated with product stability.
Subject(s)
Drug Stability , Freeze Drying , Humidity , Animals , Biological Assay , Chemistry, Pharmaceutical , Chromatography, Gas , Gallbladder/drug effects , Guinea Pigs , Oligopeptides/analysis , Sodium ChlorideABSTRACT
This report describes the isolation, derivative formation, GLC, and quantitation of unmetabolized 7-chloro-5,11-dihydrodibenz[b,e][1,4]oxazepine-5-carboxamide (I) in blood serum or plasma. Carbamazepine is used as the internal standard to compensate for losses of I during extraction and handling. Essentially complete recovery (100 +/- 6%) was demonstrated over a concentration range of 1-30 mug of I/ml of serum.
