title: The effect of rubber closures on the haze state of ceftriaxone sodium for injection.
abstract: The migration of volatile components into the headspace of glass vials from rubber closures is a potential source of haze formation in reconstituted solutions of powders for parenteral administration. In this paper, a headspace method was used to extract volatile substances from different types of rubber closures used in ceftriaxone sodium for injection whose clarity were poor. The extracts obtained were analyzed by gas chromatography (GC)-mass spectrometry (MS). An antioxidant in rubber closures, butylated hydroxytoluene (BHT), was found to affect the haze state of ceftriaxone sodium for injection.
authors.affiliation: National Institute for Control of Pharmaceutical and Biological Products, Beijing, 100050, China.
authors.forename: Xia
authors.initials: X
authors.lastname: Zhao
authors.forename: Shao-Hong
authors.initials: SH
authors.lastname: Jin
authors.forename: Chang-Qin
authors.initials: CQ
authors.lastname: Hu
mesh_terms: D000327:Adsorption; D002083:Butylated Hydroxyanisole / Q000032:analysis; D002443:Ceftriaxone / Q000008:administration & dosage* / Q000032:analysis; D004340:Drug Contamination; D004349:Drug Packaging; D008401:Gas Chromatography-Mass Spectrometry; D007267:Injections; D012408:Rubber
chemical_list: D002083:Butylated Hydroxyanisole; D002443:Ceftriaxone; D012408:Rubber