盐酸舍曲林有机杂质系统适用性对照放置7.5h后，盐酸舍曲林峰面积RSD

盐酸舍曲林有机杂质系统适用性对照放置7.5h后，盐酸舍曲林峰面积RSD为6.7%，Sertraline Related compound A峰面积RSD为4.0%2.供试品溶液放置4h后，3-Deschlorosertraline and 4-Deschlorosertraline含量的RSD为0，STHRC-3杂质的峰变大，其他最大单一杂质变大，含量RSD为7.4%，总杂质变大，含量RSD为30.0%盐酸舍曲林API有机杂质分析方法确认已经完成，可用于药品检验。盐酸舍曲林API有机杂质分析方法确认报告QC理化中心原辅包室主管秦守维QC微生物中心微生物分析主管理莫玉凡QC现场巡视员廖秋萍副经理分发部门及份数Distribution and Copies□质量保证部 □生产部 □物流部 □原料药生产制造中心□QC □计划部 □工程部 □口服制剂生产制造中心□人力资源部 □采购部 □项目部 □注射剂生产制造中心□技术开发部 □IT中心 □EHS部 □青霉素类生产制造中心□其他__________________________________

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结果 (英语) 1: [复制]

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After the organic impurities sertraline control system suitability placed 7.5h, Raymond HYDROCHLORIDE rounded area RSD of 6.7%, Sertraline Related compound A peak area was 4.0% RSD 2. The sample solution is placed after 4h, 3-Deschlorosertraline and 4 RSD -Deschlorosertraline content is 0, the peak impurity STHRC-3 becomes large, the largest single impurity other becomes large, the content of RSD 7.4%, total impurities becomes large, the content of 30.0% RSD sertraline hydrochloride API organic impurities analysis confirmed It has been completed and can be used for drug testing. Sertraline hydrochloride API organic impurity analysis method validation report QC physical and chemical center of raw package room supervisor Qinshou Wei QC microorganisms Center microbiological analysis of the main administration Mo Yu Fan QC-site inspector Liao Qiuping , vice president of distribution department and the number of copies and the Copies Distribution's □ □ Quality Assurance production □ logistics □ API manufacturing center □ QC □ planning □ Engineering □ oral formulations manufacturing center □ Human Resources □ purchasing □ □ project Department injection manufacturing center □ □ IT technology development center □ EHS Department □ penicillin manufacturing center □ others __________________________________

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结果 (英语) 2:[复制]

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After 7.5h of the suitability control of the hydrochloric acid shequlin organic impurity system, the area rsD of the hydrochloric acid shequlin peak was 6.7%, and the RSD area of Sertraline Related compound A peak area was 4.0%. 2. After placing 4h of the test solution, the RSD of 3-Dessertraline and 4-Dessertraline content is 0, the peak of STHRC-3 impurities becomes larger, the other largest single impurity becomes larger, the content of RSD is 7.4%, and the total impurity becomes larger, Content RSD is 30.0% The analysis method of the API organic impurity of hydrochloric acid has been confirmed and can be used for drug testing. Confirmation report of the analysis method of organic impurity of the api of hydrochloric acid shequlin QC Physical and Chemical Centre Former auxiliary bag room supervisor Qin Shouwei QC Microbiology Centre Master Management of Microbiological Analysis Mo Yufan QC On-site inspector Liao Qiuping Deputy Manager Distribution department and number of copies Distribution and Copies Quality Assurance Department, Production Department, Logistics Department, Raw MaterialS Manufacturing and Manufacturing Center QC, Planning Department, Engineering Department, Oral Preparation Production and Manufacturing Center Human Resources Department, Procurement Department, Project Department, Injection Production and Manufacturing Center Technology Development Department, IT Center, EHS Department, Penicillin Production and Manufacturing Center Other.

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结果 (英语) 3:[复制]

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The RSD of sertraline related compound A and sertraline related compound a were 6.7% and 4.0% respectively after 7.5h 2. After the test solution is placed for 4h, the RSD of 3-deschlorosertraline and 4-deschlorosertraline content is 0, the peak of sthrc-3 impurity becomes larger, the maximum single impurity becomes larger, the RSD of content is 7.4%, the total impurity becomes larger, the RSD of content is 30.0% API organic impurity analysis method of sertraline hydrochloride has been confirmed and can be used for drug inspection. API organic impurity analysis method confirmation report of sertraline hydrochloride QC physical and chemical center Former director of auxiliary package room Qin Wei Wei QC microbiological Center Main management of microbiological analysis Mo Yu Fan QC site inspector Liao Chiu Ping Deputy Manager Distribution and copies Quality Assurance Department Production Department Logistics Department API manufacturing center □ QC □ planning department □ Engineering Department □ oral preparation manufacturing center □ human resources department □ purchasing department □ project department □ injection production and manufacturing center □ Technology Development Department □ it center □ EHS department □ penicillin production and manufacturing center Others__________________________________

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