阿折地平片工艺验证

Technological verification of Azelnidipine Tablets

目的通过本试验来验证阿折地平片中试工艺的可行性、可靠性。方法采用同步验证法,包括多种测试手段,对阿折地平片中试工艺各步骤进行验证。结果验证批次的阿折地平片各项指标符合质量标准要求。结论阿折地平片中试工艺生产可行,工艺流程及工艺参数能够保证产品质量;工艺可靠、稳定。

Objective To verify the feasibility and reliability for the pilot process of Azelnidipine Tablets by this test. Methods The procedure of the pilot process of Azelnidipine Tablets can be verified by concurrent validation method, including many test means. Results All indexes of each batch Azelnidipine tablets can accord with the quality standard. Conclusion The pilot process of Azelnidipine Tablets was feasible and the technological process and process parameters can ensure the product quality ; The process was reliable and stable.