title: An approach for decontamination of beta-lactam antibiotic residues or contaminants in the pharmaceutical manufacturing environment.
abstract: An effective procedure for decontamination of beta-lactam antibiotic residues or contaminants in the pharmaceutical manufacturing environment was investigated. Decontamination with solutions of hydrochloric acid, sodium hydroxide, hydrogen peroxide and hydroxylamine as agents for degradation was assessed. According to the results, the beta-lactam antibiotics were significantly degraded with sodium hydroxide and hydroxylamine. From the structural analysis of the degradation products of a cephem antibiotic, cefpodoxime proxetil, it was found that hydroxylamine degraded the beta-lactam structure under mild conditions, while sodium hydroxide did not. Therefore, hydroxylamine was considered an appropriate decontamination agent for beta-lactam antibiotics.
authors.affiliation: Analytical and Quality Evaluation Research Laboratories, Sankyo Co., Ltd., 1-12-1 Shinomiya, Hiratsuka, Kanagawa 254-0014, Japan. fukutu@sankyo.co.jp
authors.forename: Naoto
authors.initials: N
authors.lastname: Fukutsu
authors.forename: Takao
authors.initials: T
authors.lastname: Kawasaki
authors.forename: Koichi
authors.initials: K
authors.lastname: Saito
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Nakazawa
mesh_terms: D000900:Anti-Bacterial Agents / Q000138:chemical synthesis / Q000737:chemistry*; D003666:Decontamination / Q000379:methods*; D004345:Drug Industry; D006863:Hydrogen-Ion Concentration; D006898:Hydroxylamines / Q000737:chemistry; D008420:Manufactured Materials; D015394:Molecular Structure; D004364:Pharmaceutical Preparations; D012972:Sodium Hydroxide / Q000737:chemistry; D047090:beta-Lactams / Q000138:chemical synthesis / Q000737:chemistry*
chemical_list: D000900:Anti-Bacterial Agents; D006898:Hydroxylamines; D004364:Pharmaceutical Preparations; D047090:beta-Lactams; D012972:Sodium Hydroxide