title: Stability of the crystalline form of cefaclor monohydrate and its pharmaceutical preparations.
abstract: The influence of temperature and relative air humidity on the stability of cefaclor monohydrate in crystalline form and in its pharmaceutical preparations (oral suspension and slow release tablets) was investigated. The process of degradation was studied by using high-performance liquid chromatography with ultraviolet (UV) detection, as described in the monograph of cefaclor in European Pharmacopoeia. The degradation of cefaclor monohydrate in substance, in oral suspension and tablets at relative air humidity RH > 50% is a first-order autocatalytic reaction relative to substrate concentration, while at 0% RH the degradation of cefaclor in substance is a first-order reaction relative to substrate concentration. The kinetic and thermodynamic parameters of degradation were calculated.
authors.affiliation: Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Poznań University of Medical Sciences, 6 Grunwaldzka St., 60-780 Poznań, Poland. bmedenecka@ump.edu.pl
authors.forename: Beata
authors.initials: B
authors.lastname: Medenecka
authors.forename: Anna
authors.initials: A
authors.lastname: Jelińska
authors.forename: Marianna
authors.initials: M
authors.lastname: Zajac
authors.forename: Magdalena
authors.initials: M
authors.lastname: Bałdyka
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Juszkiewicz
authors.forename: Irena
authors.initials: I
authors.lastname: Oszczapowicz
mesh_terms: D000900:Anti-Bacterial Agents / Q000737:chemistry*; D002433:Cefaclor / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D003460:Crystallization; D003692:Delayed-Action Preparations; D004355:Drug Stability; D004356:Drug Storage; D005060:Europe; D006813:Humidity; D010602:Pharmacopoeias as Topic; D013607:Tablets; D013696:Temperature; D013816:Thermodynamics
chemical_list: D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D013607:Tablets; D002433:Cefaclor