培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.234416574439024435844451844435054435660.29
210.204458884463844461360.08
单位质量响应值RSD%判断
43359.3443738.820.62数据可信
供试品溶液-2023041311批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1369255-36925595.20096.361.5195.2096.361.51
2380200-38020098.02298.02
3376930-37693097.17997.18
4374574-37457496.57296.57
5364933-36493394.08694.09
6376557-37655797.08397.08
10min1380218-38021898.02798.890.8698.1999.050.86
2385204-38520499.31299.48
3382785-38278598.68998.85
4379812-37981297.92298.08
5384828-38482899.21599.37
6388481-388481100.157100.32
15min1381853-38185398.44899.190.8798.7799.520.86
2386689-38668999.695100.02
3382815-38281598.69699.02
4381129-38112998.26298.59
5389593-389593100.444100.77
6386297-38629799.59499.92
20min1380667-38066798.14399.200.9398.6399.690.93
2387974-387974100.026100.52
3384010-38401099.00499.50
4380840-38084098.18798.68
5389090-389090100.314100.80
6386023-38602399.523100.02
30min1379766-37976697.91098.651.0398.5699.311.03
2386386-38638699.617100.28
3379821-37982197.92498.58
4378344-37834497.54498.20
5387904-387904100.008100.67
6383579-38357998.89399.55
极限1381854-38185498.44998.961.0199.2699.781.01
2385963-38596399.508100.34
3380784-38078498.17398.99
4379211-37921197.76798.58
5389577-389577100.440101.26
6385517-38551799.393100.22
培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.234450534452074431934453384462254450030.25
210.204459204469424464310.17
单位质量响应值RSD%判断
43499.8043767.750.44数据可信
供试品溶液-2023041311批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1366809-36680994.38595.841.9794.3995.841.97
2364014-36401493.66693.67
3371010-37101095.46695.47
4375366-37536696.58796.59
5384903-38490399.04199.04
6372558-37255895.86595.86
10min1382142-38214298.33198.761.2898.4998.921.28
2382608-38260898.45198.61
3384178-38417898.85599.01
4385998-38599899.32399.48
5391378-391378100.707100.87
6376508-37650896.88197.04
15min1383550-38355098.69398.711.1599.0199.031.15
2382776-38277698.49498.81
3382876-38287698.52098.84
4385193-38519399.11699.44
5390453-390453100.469100.80
6376799-37679996.95697.28
20min1383643-38364398.71798.671.0599.2099.161.05
2383022-38302298.55799.04
3380558-38055897.92398.41
4385809-38580999.27499.77
5389564-389564100.240100.74
6378103-37810397.29197.77
30min1381078-38107898.05798.441.2298.7199.091.22
2383838-38383898.76799.42
3379393-37939397.62398.27
4383228-38322898.61099.27
5390618-390618100.512101.18
6377182-37718297.05497.70
极限1381499-38149998.16598.350.9598.9899.160.95
2381875-38187598.26299.08
3381360-38136098.12998.94
4383351-38335198.64299.46
5388123-38812399.870100.70
6376990-37699097.00597.81
培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.234458284444564444744432724428764441810.27
210.204407944445524426730.61
单位质量响应值RSD%判断
43419.4543399.310.04数据可信
供试品溶液-2023041311批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1358783-35878392.79694.423.5792.8094.423.57
2370715-37071595.88395.88
3378290-37829097.84297.84
4356481-35648192.20192.20
5379148-37914898.06498.06
6346936-34693689.73289.73
10min1382882-38288299.02998.531.3399.1898.691.33
2383487-38348799.18699.35
3383088-38308899.08399.25
4373665-37366596.64696.80
5386736-386736100.026100.19
6375858-37585897.21397.36
15min1386699-386699100.01799.210.83100.3499.540.83
2384703-38470399.50099.83
3383977-38397799.31399.64
4378574-37857497.91598.23
5386371-38637199.932100.26
6381209-38120998.59798.91
20min1386999-386999100.09499.560.97100.58100.040.97
2388980-388980100.607101.10
3384096-38409699.34399.84
4379892-37989298.25698.73
5388125-388125100.386100.88
6381462-38146298.66299.14
30min1385395-38539599.67999.340.85100.3399.990.85
2388452-388452100.470101.13
3382851-38285199.02199.68
4378689-37868997.94598.59
5385025-38502599.584100.25
6384074-38407499.33899.98
极限1385234-38523499.63899.340.68100.46100.160.68
2387500-387500100.224101.05
3381033-38103398.55199.38
4381151-38115198.58299.39
5385795-38579599.783100.61
6383865-38386599.284100.09
培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.234427264396194431284415884432204420560.35
210.204405534423794414660.30
单位质量响应值RSD%判断
43211.7343280.980.12数据可信
供试品溶液-2023041311批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1367276-36727695.35195.503.2995.3595.503.28
2347546-34754690.22990.23
3381646-38164699.08299.08
4372942-37294296.82296.82
5375873-37587397.58397.58
6361907-36190793.95793.96
10min1378531-37853198.27398.382.5098.4398.542.50
2365701-36570194.94295.09
3388944-388944100.977101.14
4384425-38442599.80399.96
5386443-386443100.327100.49
6369675-36967595.97496.13
15min1374152-37415297.13698.202.5797.4698.522.57
2365861-36586194.98495.29
3389168-389168101.035101.37
4386893-386893100.444100.77
5383802-38380299.64299.97
6369637-36963795.96496.28
20min1374648-37464897.26598.162.6897.7598.642.68
2365252-36525294.82695.29
3388429-388429100.843101.34
4389270-389270101.061101.56
5382079-38207999.19499.69
6368863-36886395.76396.24
30min1372187-37218796.62698.102.8097.2798.752.80
2364624-36462494.66395.29
3389673-389673101.166101.84
4389588-389588101.144101.81
5381036-38103698.92499.58
6370010-37001096.06196.70
极限1372659-37265996.74997.722.4397.5698.532.43
2364554-36455494.64595.43
3384991-38499199.950100.79
4385606-385606100.110100.94
5382425-38242599.284100.11
6368117-36811795.57096.37
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