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%
110.524546474555994550634562144558214554690.14
210.384528144522864525500.09
单位质量响应值RSD%判断
43295.5343598.270.50数据可信
供试品溶液-2025072412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%
5min1246758-24675863.76851.8215.2163.7751.8215.21
2154623-15462339.95839.96
3213098-21309855.06955.07
4188358-18835848.67648.68
5207107-20710753.52153.52
6193280-19328049.94849.95
10min1375555-37555597.05295.822.7597.1695.902.75
2358894-35889492.74692.81
3360701-36070193.21393.30
4380756-38075698.39698.48
5366476-36647694.70594.79
6382344-38234498.80698.89
15min1384382-38438299.33399.141.3399.6099.391.34
2380043-38004398.21198.43
3380806-38080698.40998.66
4390971-390971101.036101.28
5377665-37766597.59797.84
6388008-388008100.270100.52
20min1386460-38646099.87099.201.29100.3099.621.29
2380384-38038498.30098.68
3379014-37901497.94698.36
4388930-388930100.508100.92
5379125-37912597.97498.38
6389408-389408100.632101.05
30min1387214-387214100.06599.081.46100.6699.661.46
2380756-38075698.39698.94
3380060-38006098.21698.79
4388357-388357100.360100.94
5375156-37515696.94997.52
6388873-388873100.493101.08
极限1385504-38550499.62398.911.24100.3999.651.24
2379362-37936298.03698.75
3380991-38099198.45699.19
4388921-388921100.506101.25
5376205-37620597.22097.95
6385579-38557999.642100.39
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%
110.524534244529244526584533334530714530820.07
210.384508614509794509200.02
单位质量响应值RSD%判断
43068.6343441.230.61数据可信
供试品溶液-2025072412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%
5min1175298-17529845.50252.0516.9645.5052.0516.96
2234962-23496260.98960.99
3168185-16818543.65643.66
4165516-16551642.96342.96
5230167-23016759.74559.74
6228941-22894159.42659.43
10min1374170-37417097.12496.762.8897.2096.842.88
2364799-36479994.69194.79
3381461-38146199.01699.09
4356721-35672192.59492.67
5373364-37336496.91497.01
6386037-386037100.204100.30
15min1383602-38360299.57299.471.8599.8199.721.84
2377414-37741497.96698.23
3392191-392191101.801102.04
4375172-37517297.38497.61
5380043-38004398.64898.91
6390934-390934101.475101.74
20min1381797-38179799.10399.271.7499.5199.681.73
2373446-37344696.93697.36
3391672-391672101.667102.07
4377974-37797498.11198.50
5381567-38156799.04499.47
6388128-388128100.747101.18
30min1382694-38269499.33699.211.3799.9099.791.38
2377830-37783098.07498.66
3388124-388124100.746101.32
4375122-37512297.37197.92
5381696-38169699.07799.67
6387864-387864100.678101.28
极限1384446-38444699.79199.301.73100.53100.051.73
2377199-37719997.91098.66
3390751-390751101.427102.17
4373420-37342096.92997.64
5381304-38130498.97599.73
6388312-388312100.794101.57
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%
110.524501894513004506184521194515704511590.17
210.384537154546314541730.15
单位质量响应值RSD%判断
42885.8443754.621.42数据可信
供试品溶液-2025072512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%
5min1126081-12608132.68049.1539.6732.6849.1539.66
2126403-12640332.76432.76
3287877-28787774.61874.62
4225933-22593358.56258.56
5117769-11776930.52630.53
6253757-25375765.77465.77
10min1355175-35517592.06295.312.6392.1295.392.65
2360958-36095893.56193.62
3373875-37387596.90997.03
4379155-37915598.27798.37
5361727-36172793.76093.81
6375363-37536397.29497.40
15min1376628-37662897.62298.441.0997.8398.681.11
2378642-37864298.14498.35
3377043-37704397.73098.02
4386458-386458100.170100.43
5376673-37667397.63497.84
6383249-38324999.33899.61
20min1376670-37667097.63398.751.2598.0099.161.26
2378888-37888898.20898.58
3377835-37783597.93598.38
4388906-388906100.805101.23
5379097-37909798.26298.63
6384574-38457499.682100.12
30min1377110-37711097.74798.791.0698.2899.361.08
2379839-37983998.45498.99
3380137-38013798.53299.14
4387476-387476100.434101.03
5377902-37790297.95298.49
6384452-38445299.650100.25
极限1374249-37424997.00698.601.5197.7099.341.53
2378756-37875698.17498.88
3380598-38059898.65199.43
4388370-388370100.666101.43
5374820-37482097.15497.85
6385669-38566999.966100.74
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%
110.524542924546404537544518004537234536420.25
210.384531274521014526140.17
单位质量响应值RSD%判断
43121.8643604.430.79数据可信
供试品溶液-2025072512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%
5min1206931-20693153.58065.1919.9453.5865.1919.94
2308090-30809079.77379.77
3187399-18739948.52248.52
4308448-30844879.86579.87
5254961-25496166.01666.02
6244745-24474563.37163.37
10min1379122-37912298.16598.401.9098.2598.511.89
2370269-37026995.87296.01
3383698-38369899.34999.43
4388065-388065100.480100.61
5373031-37303196.58796.70
6385953-38595399.933100.04
15min1388125-388125100.49699.711.65100.7599.991.63
2375842-37584297.31597.61
3390015-390015100.985101.23
4388107-388107100.491100.79
5378332-37833297.96098.23
6390212-390212101.036101.31
20min1388837-388837100.68099.701.53101.10100.131.51
2375078-37507897.11797.57
3391593-391593101.394101.81
4384244-38424499.49199.96
5382564-38256499.05699.49
6387881-387881100.432100.87
30min1387426-387426100.31599.701.26100.90100.301.24
2376156-37615697.39798.01
3389296-389296100.799101.38
4386799-386799100.152100.79
5383088-38308899.19199.79
6387580-387580100.355100.96
极限1386629-386629100.10899.551.13100.86100.321.12
2377103-37710397.64298.42
3388270-388270100.533101.28
4385740-38574099.878100.68
5381385-38138598.75199.52
6387615-387615100.364101.14
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%
110.524534434530344537914547364531344536280.16
210.384553244560644556940.12
单位质量响应值RSD%判断
43120.5343901.161.27数据可信
供试品溶液-2025072612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%
5min1222537-22253757.42837.4730.0357.4337.4730.03
2109101-10910128.15528.15
3167198-16719843.14743.15
4107811-10781127.82227.82
5132691-13269134.24234.24
6131843-13184334.02334.02
10min1375625-37562596.93493.613.2297.0393.673.23
2343111-34311188.54388.59
3364782-36478294.13694.21
4360857-36085793.12393.17
5358927-35892792.62592.68
6373120-37312096.28796.34
15min1387711-387711100.05399.461.54100.3199.671.53
2382041-38204198.58998.78
3378042-37804297.55797.79
4389499-389499100.514100.72
5381315-38131598.40298.61
6393765-393765101.615101.83
20min1388352-388352100.21899.621.45100.64100.001.45
2383575-38357598.98599.34
3378466-37846697.66798.06
4391741-391741101.093101.46
5381879-38187998.54898.92
6392093-392093101.183101.57
30min1387202-38720299.92199.541.63100.51100.101.62
2382835-38283598.79499.32
3378299-37829997.62498.18
4392692-392692101.338101.88
5380393-38039398.16498.70
6393017-393017101.422101.98
极限1388713-388713100.31199.721.71101.07100.441.70
2380714-38071498.24798.94
3378645-37864597.71398.43
4394203-394203101.728102.43
5383006-38300698.83899.54
6393222-393222101.475102.20
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%
110.524511514514334525704519514518244517860.12
210.384541314539164540240.04
单位质量响应值RSD%判断
42945.4443740.271.30数据可信
供试品溶液-2025072612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%
5min1124106-12410632.15140.4826.5732.1540.4826.58
2137110-13711035.52035.52
3192392-19239249.84149.84
4212984-21298455.17655.18
5165750-16575042.93942.94
6105232-10523227.26227.26
10min1365312-36531294.63896.871.1794.6996.941.18
2373899-37389996.86396.92
3377143-37714397.70397.79
4376176-37617697.45397.54
5375742-37574297.34097.41
6375333-37533397.23497.28
15min1381816-38181698.91499.280.7999.1299.500.77
2386228-386228100.057100.28
3383668-38366899.39399.64
4378733-37873398.11598.37
5382149-38214999.00099.23
6386716-386716100.183100.39
20min1382848-38284899.18199.290.7699.5699.680.75
2387917-387917100.494100.88
3383746-38374699.41499.83
4379171-37917198.22898.65
5381774-38177498.90399.30
6384118-38411899.51099.88
30min1382081-38208198.98298.920.9199.5299.480.90
2386962-386962100.247100.80
3382480-38248099.08699.66
4376061-37606197.42398.00
5381581-38158198.85399.42
6381980-38198098.95699.50
极限1379309-37930998.26498.751.0798.9799.481.05
2387417-387417100.365101.09
3379879-37987998.41299.15
4375900-37590097.38198.13
5380409-38040998.54999.28
6384214-38421499.535100.24
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