医药公司硝酰胺酯加速和长期稳定性试验报告.doc

第 1 页 共 8 页 METHYL 4 BUTYRYLAMINO 3 METHYL 5 NITROBENZOATE STABILITY TEST REPORT 报告编号 Protocol No XG1116 001 00 2 版本 VersionB 生效日期 Eff Date2011 3 28 签名程序 Procedure编制 Prepared by审核 verified by审核 verified by批准 Approved by 部门 DeptQCQCQA质量副总 姓名 Name 签名 Signature 日期 Date 第 2 页 共 8 页 稳定性研究稳定性研究 STABILITY TEST 1 长期稳定性研究长期稳定性研究Long Term Stability Test 取样品 模拟上市包装 内包装 两层聚乙烯袋 扎口密封 外包装 纸质圆桶 在适宜温度和湿度的储存条件 温度 25 2 相对湿度 60 5 恒温恒湿箱中留样观察 分别在 0 3 6 9 12 18 24 36 月末取样 按产品质量标准和检验规程中规定的稳定性重点考察项目检测 将结 果与 0 月比较 在 36 月进行全面检测 如果未到 36 月某项目检测连续两个考察阶段不合格 则该批号判为不合格 不再继续观察 此两个考察阶段应 进行全面检测 Sampling in room condition temperature 25 2 Humidity 60 5 in standard export packing and testing in the end of every three months for 36 months and comparing with the beginning results 2 加速试验研究加速试验研究Accelerated Stability Test 取样品 模拟上市包装 内包装 两层聚乙烯袋 扎口密封 外包装 纸质圆桶 在适宜温度和湿度的储存条件 温度 40 2 相对湿度 75 5 恒温恒湿箱中留样观察 分别在 0 1 2 3 和 6 月末取样 按产品质量标准和检验规程中规定的稳定性重点考察项目检测 将结果与 0 月比较 Sampling in set condition temperature 40 2 Humidity75 5 in standard export packing and testing in the end of month 0 1st 2nd 3rd and 6th and comparing with the beginning results 3 结论结论Conclusion 3 1 长期稳定性实验考核结果长期稳定性实验考核结果 2008 年生产的批号为 20080101 20080102 20080103 三批样品在第 0 3 6 9 12 18 24 36 个月考察了重点检验项目 各项指标均符合规定 并且不同时间的检测数据基本一致 表明样品在长期稳定性实验中 0 3 6 9 12 18 24 36 个月内基本稳定 Sampling for 3 batches in20080101 20080102 20080103 Testing the results in the end of month 0 1st 2nd 3rd 6th 9th 12th 18th 24th and 36th Found the material steady 第 3 页 共 8 页 批号批号 Batch No 20080101 长期稳定性研究长期稳定性研究 Long Term Stability Test 检测项目检测项目 Test item 规格规格 Standard03M6M9M12M18M24M36M 检测日期检测日期 Test date 2008 1 122008 4 142008 7 142008 10 132009 1 122009 7 112010 1 122011 1 13 外观外观 Appearance white to off white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder 鉴别鉴别 HPLC Identification Must conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard 水分 水分 KF Water 0 5 0 08 0 08 0 10 0 09 0 11 0 14 0 21 0 32 单一杂质单一杂质 HPLC A Any single impurity 0 3 0 22 0 23 0 23 0 25 0 24 0 24 0 25 0 28 纯度 纯度 HPLC A purity 99 0 99 3 99 3 99 4 99 4 99 3 99 4 99 4 99 2 第 4 页 共 8 页 批号 批号 Batch No 20080102 长期稳定性研究长期稳定性研究 Long Term Stability Test 检测项目检测项目 Test item 规格规格 Standard03M6M9M12M18M24M36M 检测日期检测日期 Test date 2008 1 122008 4 142008 7 142008 10 132009 1 122009 7 112010 1 122011 1 13 外观外观 Appearance white to off white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder 鉴别鉴别 HPLC Identification Must conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard 水分 水分 KF Water 0 5 0 10 0 11 0 12 0 09 0 12 0 14 0 19 0 25 单一杂质单一杂质 HPLC A Any single impurity 0 3 0 20 0 19 0 20 0 20 0 21 0 22 0 22 0 25 纯度 纯度 HPLC A purity 99 0 99 4 99 4 99 4 99 3 99 3 99 3 99 4 99 3 第 5 页 共 8 页 批号 批号 Batch No 20080103 长期稳定性研究长期稳定性研究 Long Term Stability Test 检测项目检测项目 Test item 规格规格 Standard03M6M9M12M18M24M36M 检测日期检测日期 Test date 2008 1 122008 4 142008 7 142008 10 132009 1 122009 7 112010 1 122011 1 13 外观外观 Appearance white to off white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder 鉴别鉴别 HPLC Identification Must conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard 水分 水分 KF Water 0 5 0 08 0 09 0 10 0 10 0 11 0 15 0 20 0 25 单一杂质单一杂质 HPLC A Any single impurity 0 3 0 23 0 23 0 22 0 25 0 24 0 24 0 25 0 25 纯度 纯度 HPLC A purity 99 0 99 4 99 3 99 3 99 3 99 4 99 3 99 3 99 3 第 6 页 共 8 页 3 2 加速稳定性实验考核结果加速稳定性实验考核结果 2008 年生产的批号为 20080101 20080102 20080103 三批样品在第 0 1 2 3 6 个月考察了重点检验项目 各项指标均符合规定 并且不同时 间的检测数据基本一致 表明样品在加速稳定性实验中 0 1 2 3 6 个月内基本稳定 Sampling for 3 batches in 20080101 20080102 20080103 Testing the results in the end of month 0 1st 2nd 3rd and 6th Found the material steady 批号 批号 Batch No 20080101 加速试验研究加速试验研究 Accelerated Stability Test 检测项目检测项目 Test item 规格规格 Standard01M2M3M6M 检测日期检测日期 Test date 2008 1 122008 2 132008 3 122008 4 142008 7 14 外观外观 Appearance white to off white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder 鉴别鉴别 HPLC Identification Must conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard 水分 水分 KF Water 0 5 0 08 0 08 0 10 0 09 0 11 单一杂质 单一杂质 HPLC A Any single impurity 0 3 0 22 0 23 0 24 0 25 0 25 纯度 纯度 HPLC A purity 99 0 99 3 99 3 99 4 99 3 99 4 第 7 页 共 8 页 批号 批号 Batch No 20080102 加速试验研究加速试验研究 Accelerated Stability Test 检测项目检测项目 Test item 规格规格 Standard01M2M3M6M 检测日期检测日期 Test date 2008 1 122008 2 132008 3 122008 4 142008 7 14 外观外观 Appearance white to off white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder white crystalline powder 鉴别鉴别 HPLC Identification Must conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard conform to reference standard 水分 水分 KF Water 0 5 0 10 0 11 0 12 0 09 0 12 单一杂质 单一杂质 HPLC A Any single impurity 0 3 0 20 0 21 0 21 0 20 0 21 纯度 纯度 HPLC A purity 99 0 99 4 99 3 99 3 99 3 99 4 第 8 页 共 8 页 批号 批号 Batch No 20080103 加速试验研究加