Lyophilization of sincalide and correlation of headspace relative humidity with product stability.
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.
D000818:Animals; D001681:Biological Assay; D002626:Chemistry, Pharmaceutical; D002849:Chromatography, Gas; D004355:Drug Stability; D005612:Freeze Drying; D005704:Gallbladder / Q000187:drug effects; D006168:Guinea Pigs; D006813:Humidity; D009842:Oligopeptides / Q000032:analysis; D012965:Sodium Chloride
D009842:Oligopeptides; D012965:Sodium Chloride