title: Determination of cefmetazole residue at pharmaceutical manufacturing facilities by chemiluminescence flow injection analysis.
abstract: Application of a sensitive and rapid flow injection analysis (FIA) method with luminol chemiluminescence detection for determination of trace amounts of cefmetazole (CMZ) in cephamycin antibiotic residue in pharmaceutical manufacturing facilities and on pharmaceutical manufacturing equipment has been investigated. The method was shown to be sensitive at a level of limit of detection of 0.06 ng/ml and for linear concentrations in the range of 0.3-1.5 ng/ml. Average recoveries of CMZ from stainless steel plates and glass plates were 62.1% and 60.1%, respectively, by adding 15 ng/100 cm2, and that of air sampling filters was 91.9% by adding 3 ng/filter. The proposed method has been successfully applied to the determination of CMZ residue in samples collected from an actual manufacturing facility and equipment. According to the results, no detectable CMZ residue was observed, therefore it was verified that no contamination had occurred to other pharmaceutical products manufactured in the facility.
authors.affiliation: Analytical and Quality Evaluation Research Laboratories, Sankyo Co. Ltd., 1-12-1 Shinomiya, Hiratsuka-shi, Kanagawa 254-0014, Japan. fukutu@sankyo.co.jp
authors.forename: Naoto
authors.initials: N
authors.lastname: Fukutsu
authors.forename: Tomonori
authors.initials: T
authors.lastname: Konse
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 / Q000032:analysis*; D015311:Cefmetazole / Q000032:analysis*; D004340:Drug Contamination / Q000517:prevention & control; D004345:Drug Industry; D004866:Equipment Contamination / Q000517:prevention & control; D017022:Flow Injection Analysis / Q000379:methods*; D005898:Glass; D049449:Luminescence; D008165:Luminol; D015203:Reproducibility of Results; D013193:Stainless Steel; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods
chemical_list: D000900:Anti-Bacterial Agents; D013193:Stainless Steel; D015311:Cefmetazole; D008165:Luminol