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 IPC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, the workshop staff member Bai Quanyin found that it was sent to API IPC 1100-E190901, 1100-E190903 when reviewing the inspection report of the stability of idarubicin hydrochloride (E process) crude product for 2 months , 1100-E191001 Two batches of two-month stability inspection report name is "Idarubicin hydrochloride crude product stability for three months", according to H3-VD-80054-P "Idarubicin hydrochloride (E process) intermediate Body Stability Program "and H3-VD-50491-P-R01" Idarubicin Hydrochloride (Process E) Sampling Method and Record for Process Validation ", the name of the three batches of crude product stability inspection report should be" Ida Hydrochloride It is stable for 2 months than the crude product. "

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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, 11 to API IPC when reviewing the inspection report sheet for the stability of the ydabis (E process) crude products. 00-E190903, 1100-E191001 three batches of rough 2 months stability test report single name is "Idabi star crude 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, The workshop staff Bai Quanyin found that when reviewing the 2-month inspection report on the stability of crude products of edabisin hydrochloride (e process), it was sent to API The two-month stability test report of three batches of crude products (1100-e1901, 1100-e190903 and 1100-e191001) of IPC is named "three months stability test of crude products of IDA bicin hydrochloride". According to h3-vd-80054-p intermediate stability scheme of IDA bicin hydrochloride (e process) and h3-vd-50491-p-r01 sampling method and record for process validation of IDA bicin salt (e process), the stability test of these three batches of crude products is carried out The name of the inspection report shall be "stability of crude product of IDA bicin hydrochloride for 2 months".<br>

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