|
|
|
| Experimental Research on Effectively Reducing Residual Solvents in Amoxicillin |
| DONG Rong-mei1, YAN Jian-ming2, JIN Xian-rui1 |
| 1.CSPC Zhongruo Pharmaceutical Corporation Ltd.,Shijiazhuang 050041,China; 2. Shijiazhuang Bailong Chemical Corporation Ltd.,Shijiazhuang 050031, China |
|
|
|
|
Abstract Based on the Chinese Pharmacopeia specification of residual solvents in amoxicillin drug substance,the experiments were designed and conducted to evaluate the influence factors on residual solvents, including different type of stirring paddles, ammonia water adding speed, drying pattern, etc.The results showed that adding ammonia water with varying speed in different phases using paddle agitator, and drying with ammonia gas back flushing in electro- thermostatic blast oven can the solvent residue in amoxicillin could be reduced and the product quality could be improved to meet the requirements in different countries.
|
|
|
|
|
|
| [ 1 ] ICH指导委员会.药品注册的国际技术要求2007质量部分[ M ]. 北京:人民卫生出版社,2007:129 - 144.[ 2 ] 《化学药物残留溶剂研究技术指导原则》课题研究组. 化学药物残留溶剂研究的技术指导原则[ M ]. 北京:国家食品药品监督管理局,2005:1 - 4.[ 3 ] 国家药典委员会.中华人民共和国药典(2010 年版 二部)[ M ]. 北京:中国医药科技出版社, 2010:凡例ⅩⅣ.[ 4 ] 潘永亮,刘玉良. 化工设备机械设计基础[ M ]. 北京:科学出版社,2004:286 - 290. |
|
|
|