The effect of rubber closures on the haze state of ceftriaxone sodium for injection.
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.
Zhao
Xia
X
National Institute for Control of Pharmaceutical and Biological Products, Beijing, 100050, China.
Jin
Shao-Hong
SH
Hu
Chang-Qin
CQ
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
D002083:Butylated Hydroxyanisole; D002443:Ceftriaxone; D012408:Rubber