文档介绍：盐酸左氧氟沙星氯化钠注射液工艺验证
摘要:为验证盐酸左氧氟沙星氯化钠注射液的制备工艺,在制备过程中对左氧氟沙星、氯化钠、EDTA-2Na、药用炭[1]的用量及配制时间、灭菌温度等可能会影响到成品质量的因素进行严格控制,从而对盐酸左氧氟沙星氯化钠注射液的工艺进行再验证。结果:按照处方工艺配制盐酸左氧氟沙星氯化钠注射液,通过检测其性状为淡黄绿色澄明液体;-;装量在100-102mL(-)范围内;内毒素< ;%,相对偏差为0 小于2010年版药典规定的3%。%;%%;澄明度检查无白点、白块、纤维、色点、塑胶屑等不合格品。以上结果表明,按照处方工艺进行生产,生产出的盐酸左氧氟沙星氯化钠注射液各项指标均符合国家药典标准,证实该系统能持续稳定地生产出符合质量标准和预定用途的盐酸左氧氟沙星氯化钠注射液。
关键词:盐酸左氧氟沙星氯化钠注射液;制备;性状;pH;装量;内毒素;含量;澄明度
Levofloxacin hydrochloride and sodium chloride injection process revalidation
LI FAN-fan
(Class 1 of Pharmaceutic Preparation, Graduated in 2015)
Abstract Objective: levofloxacin hydrochloride and sodium chloride injection process in the preparation of centre-left ofloxacin, sodium chloride, EDTA - 2 na, the dosage of the medicinal charcoal and preparation time, sterilization temperature will affect the quality of products, through strict control of the process of levofloxacin hydrochloride and sodium chloride injection process for revalidation. Methods: according to the prescription pound levofloxacin hydrochloride and sodium chloride injection, good control during the process of preparation may be all the external factors affect the finished product. Results: according to the prescription craft to produce the levofloxacin hydrochloride and sodium chloride injection of various indexes meet the natio