磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.543353503362143363053373903369923364500.24
212.473382043357293369660.52
单位质量响应值RSD%判断
26830.1427022.130.51数据可信
供试品溶液-2025041011批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1385244-38524499.96098.072.7799.9698.072.77
2388030-388030100.683100.68
3363839-36383994.40694.41
4387437-387437100.529100.53
5374861-37486197.26697.27
6368340-36834095.57495.57
10min1388759-388759100.87299.302.50101.0499.462.50
2390824-390824101.408101.58
3367198-36719895.27795.43
4391585-391585101.605101.77
5380513-38051398.73298.89
6377385-37738597.92198.08
15min1389535-389535101.07399.122.69101.4199.452.69
2390635-390635101.359101.70
3366095-36609594.99195.31
4391446-391446101.569101.91
5378874-37887498.30798.63
6375429-37542997.41397.74
20min1387890-387890100.64698.922.65101.1599.412.65
2391088-391088101.476101.98
3366202-36620295.01995.49
4390288-390288101.268101.77
5377186-37718697.86998.36
6374663-37466397.21497.70
30min1386875-386875100.38398.822.71101.0599.482.71
2390505-390505101.325102.00
3364297-36429794.52595.16
4390162-390162101.236101.91
5378449-37844998.19798.85
6374898-37489897.27597.92
45min1386934-386934100.39898.732.68101.2499.552.68
2389347-389347101.024101.87
3363596-36359694.34395.13
4389518-389518101.069101.91
5377915-37791598.05898.88
6375661-37566197.47398.28
极限1386762-386762100.35498.602.53101.3699.592.54
2388710-388710100.859101.87
3365094-36509494.73195.68
4388580-388580100.825101.84
5376588-37658897.71498.69
6374282-37428297.11598.09
磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.543384103384503373103363453363573373740.31
212.473360863346163353510.31
单位质量响应值RSD%判断
26903.8326892.620.03数据可信
供试品溶液-2025041011批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1377304-37730498.00099.001.3298.0099.001.32
2374078-37407897.16297.16
3385084-385084100.021100.02
4387694-387694100.699100.70
5382639-38263999.38699.39
6380211-38021198.75598.75
10min1381553-38155399.103100.001.4199.27100.171.41
2376836-37683697.87898.04
3387906-387906100.754100.92
4392701-392701101.999102.17
5385947-385947100.245100.41
6385154-385154100.039100.20
15min1381227-38122799.01999.791.3399.35100.121.33
2376130-37613097.69598.02
3386734-386734100.449100.78
4391083-391083101.579101.92
5384698-38469899.920100.25
6385382-385382100.098100.43
20min1380180-38018098.74799.441.4999.2499.941.49
2374118-37411897.17297.66
3386719-386719100.445100.95
4390411-390411101.404101.91
5381067-38106798.97799.48
6384651-38465199.908100.41
30min1379926-37992698.68199.541.5399.34100.201.53
2373833-37383397.09897.75
3385655-385655100.169100.84
4391185-391185101.605102.28
5384196-38419699.790100.45
6384548-38454899.881100.55
45min1379267-37926798.51099.361.6299.33100.181.62
2372406-37240696.72897.54
3385878-385878100.227101.06
4390585-390585101.449102.29
5383510-38351099.612100.44
6383521-38352199.615100.45
极限1374873-37487397.36899.041.5898.36100.041.58
2373751-37375197.07798.05
3384351-38435199.830100.83
4389671-389671101.212102.23
5382663-38266399.392100.39
6382506-38250699.351100.35
磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.543376623373693371133369393368363371840.10
212.473401763374893388320.57
单位质量响应值RSD%判断
26888.6827171.770.75数据可信
供试品溶液-2025041111批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1376413-37641397.29495.484.2397.2995.484.23
2373879-37387996.63996.64
3384829-38482999.46999.47
4339554-33955487.76787.77
5373457-37345796.53096.53
6368170-36817095.16395.16
10min1380363-38036398.31597.172.8498.4897.332.84
2377099-37709997.47197.63
3387680-387680100.206100.37
4355782-35578291.96192.11
5377812-37781297.65597.82
6376793-37679397.39297.55
15min1378902-37890297.93797.232.7598.2697.562.76
2376399-37639997.29097.61
3387550-387550100.172100.51
4356587-35658792.16992.47
5378542-37854297.84498.17
6379097-37909797.98798.31
20min1381081-38108198.50097.532.8198.9998.012.82
2377049-37704997.45897.94
3387146-387146100.068100.57
4356977-35697792.27092.72
5378357-37835797.79698.28
6383300-38330099.07499.56
30min1382839-38283998.95597.252.5499.6197.902.55
2379474-37947498.08598.73
3378414-37841497.81198.48
4356975-35697592.26992.88
5379499-37949998.09198.74
6380226-38022698.27998.93
45min1381081-38108198.50097.342.7799.3298.142.77
2374894-37489496.90197.71
3387575-387575100.179101.01
4357091-35709192.29993.06
5380359-38035998.31499.13
6378462-37846297.82398.64
极限1380164-38016498.26397.522.7299.2598.502.72
2376574-37657497.33598.31
3388551-388551100.431101.43
4358096-35809692.55993.47
5379226-37922698.02199.00
6381201-38120198.53199.51
磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.543401913400043396043397063402813399570.09
212.473416043410433413240.12
单位质量响应值RSD%判断
27109.8127371.610.68数据可信
供试品溶液-2025041111批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1385749-38574998.93698.333.9098.9498.333.90
2383039-38303998.24198.24
3396416-396416101.672101.67
4354499-35449990.92190.92
5392225-392225100.597100.60
6388420-38842099.62199.62
10min1388269-38826999.58298.973.8299.7599.143.82
2386000-38600099.00099.16
3399903-399903102.566102.74
4357734-35773491.75191.90
5394774-394774101.251101.42
6388691-38869199.69199.86
15min1388762-38876299.70998.763.85100.0499.093.85
2386393-38639399.10199.43
3394388-394388101.152101.49
4355573-35557391.19691.50
5394516-394516101.184101.52
6390775-390775100.225100.56
20min1388898-38889899.74499.143.76100.2499.643.75
2385282-38528298.81699.31
3399018-399018102.339102.85
4358675-35867591.99292.45
5395741-395741101.499102.00
6391705-391705100.464100.96
30min1389124-38912499.80298.953.69100.4699.613.69
2385558-38555898.88799.55
3398428-398428102.188102.87
4358072-35807291.83792.45
5392723-392723100.725101.40
6390847-390847100.243100.91
45min1387718-38771899.44198.663.69100.2799.483.69
2383351-38335198.32199.14
3397180-397180101.868102.72
4357654-35765491.73092.49
5394630-394630101.214102.06
6387554-38755499.399100.23
极限1386817-38681799.21098.683.83100.2199.673.83
2384534-38453498.62499.61
3397049-397049101.834102.85
4356108-35610891.33492.25
5393117-393117100.826101.84
6390839-390839100.241101.24
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