The control of the critical quality attributes of amoxicillin and clavulanate potassium tablet
- VernacularTitle:阿莫西林克拉维酸钾片剂的关键质量属性与控制
- Author:
Xiao-meng CHONG
1
;
Jin LI
1
;
Yan WANG
1
;
Chen WANG
1
;
Li-xin WANG
1
;
Shang-chen YAO
1
;
Chang-qin HU
1
Author Information
- Publication Type:ORIGINAL ARTICLES
- Keywords: amoxicillin and clavulanate potassium; impurity profile; critical quality attribute; penicilloic acid
- From: Acta Pharmaceutica Sinica 2016;51(7):1121-
- CountryChina
- Language:Chinese
- Abstract: The critical attribute was analyzed in clavulanate potassium tablet of amoxicillin according to the principle QbD. By investigation of the drug impurity profile, the cycle-closed dimer and penicilloic acid of amoxicillin were considered to be the critical impurities, and the sources and the degradation pathways of these two impurities were discussed. The research confirmed that crystal form was the critical attribute of drug substance. The drying process in the tablet granulation was regarded as the critical process parameter. The tablet formulation was also another factor in the impurity generation. This study provides a new idea for the evaluation of drug quality.
