Stability of the crystalline form of cefaclor monohydrate and its pharmaceutical preparations.
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.
Medenecka
Beata
B
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Poznań University of Medical Sciences, 6 Grunwaldzka St., 60-780 Poznań, Poland. bmedenecka@ump.edu.pl
Jelińska
Anna
A
Zajac
Marianna
M
Bałdyka
Magdalena
M
Juszkiewicz
Krzysztof
K
Oszczapowicz
Irena
I
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
D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D013607:Tablets; D002433:Cefaclor