2019年12月05日下午15:50,车间人员白全印在审核盐酸伊达比星

2019年12月05日下午15:50,车间人员白全印在审核盐酸伊达比星（E工艺）粗品稳定性2个月的检验报告单时，发现送至API的1100-E190901、1100-E190903、1100-E191001三批粗品2个月稳定性检验报告单名称为“盐酸伊达比星粗品稳定性3个月”，根据H3-VD-80054-P《盐酸伊达比星（E工艺）中间体稳定性方案》及H3-VD-50491-P-R01《盐酸伊达比星（E工艺）工艺验证取样方法与记录》，该三批粗品稳定性检验报告单的名称应为“盐酸伊达比星粗品稳定性2个月”。

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结果 (英语) 1: [复制]

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At 15:50 pm on December 05, 2019, workshop personnel Bai Quanyin found that 1100-E190901, 1100-E190903, which were sent to the API, when reviewing the two-month inspection report of the stability of idarubicin hydrochloride (E process) 1100-E191001 Two batches of crude product stability test report name for 2 months is "Idarubicin hydrochloride crude product stability for 3 months", according to H3-VD-80054-P "Idarubicin hydrochloride (E process) intermediate "Stability Program" and H3-VD-50491-P-R01 "Idabicin Hydrochloride (Process E) Sampling Method and Record for Process Validation", the name of the three batches of crude product stability inspection report should be "Idabi Hydrochloride Star crude product stability for 2 months ".

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结果 (英语) 2:[复制]

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On December 5, 2019, at 15:50 p.m., the workshop staff, Bai Quanprinting, found 1100-E190901, 110 sent to API when reviewing the inspection report sheet for the stability of the yidabi star (E process) crude products. 0-E190903, 1100-E191001 three batches of rough 2 months stability test report single name is "Idabi star crude stability stability 3 months", according to H3-VD-80054-P The Intermediate Stability Scheme of Idaby star (E process) of hydrochloric acid (E process) and H3-VD-50491-P-R01 "Idabistar hydrochloric acid (E process) process verification sampling method and record", the name of the three batch of crude stability inspection report sheet should be "Idabi star coarse stability for 2 months".

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结果 (英语) 3:[复制]

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15:50 PM, December 5, 2019, Workshop staff Bai Quanyin found that the two-month stability test report of three batches of crude products (1100-e190901, 1100-e190903 and 1100-e191001) sent to API was named "three months stability test report of crude products of IDA bicin hydrochloride", according to h3-vd-80054-p intermediate stability plan of IDA bicin hydrochloride (e process) And h3-vd-50491-p-r01 sampling method and record for process validation of idabitin hydrochloride (e process), the name of the three batches of crude product stability test report sheet shall be "2 months for the stability of crude product of idabitin hydrochloride".<br>

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