氢氯噻嗪坎地沙坦酯片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.014632784631674629624632334629954631270.04
212.064608714608854608780.01
单位质量响应值RSD%判断
38561.7838215.420.64数据可信
加速6月-供试品溶液-2024082321批-氢氯噻嗪-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%
5min1338334-33833463.26773.7312.9463.2773.7312.94
2446858-44685883.56183.56
3343209-34320964.17964.18
4429181-42918180.25580.26
5443374-44337482.91082.91
6364757-36475768.20868.21
10min1475998-47599889.01093.954.5589.1294.074.56
2527823-52782398.70198.84
3484860-48486090.66790.77
4510708-51070895.50195.63
5527938-52793898.72398.86
6487128-48712891.09191.21
15min1514801-51480196.26698.471.8596.5298.751.87
2535553-535553100.147100.45
3519194-51919497.08897.35
4529516-52951699.01899.31
5539305-539305100.848101.15
6521091-52109197.44297.71
20min1528058-52805898.74599.921.1399.16100.371.15
2535305-535305100.100100.57
3529814-52981499.07499.49
4535030-535030100.049100.51
5545137-545137101.939102.41
6532851-53285199.641100.07
30min1536511-536511100.326100.740.90100.90101.350.92
2535366-535366100.112100.75
3533734-53373499.807100.39
4540923-540923101.151101.78
5547180-547180102.321102.96
6538739-538739100.742101.34
45min1538704-538704100.736100.881.00101.48101.651.00
2534444-53444499.939100.74
3534327-53432799.917100.67
4541565-541565101.271102.06
5548758-548758102.616103.43
6538924-538924100.777101.54
60min1536984-536984100.414100.821.02101.33101.771.03
2534042-53404299.864100.84
3534663-53466399.980100.90
4541715-541715101.299102.26
5548756-548756102.616103.60
6538830-538830100.759101.69
极限1536928-536928100.404100.980.98101.49102.100.99
2535989-535989100.228101.37
3534787-534787100.003101.09
4543186-543186101.574102.70
5548658-548658102.597103.75
6540609-540609101.092102.19
氢氯噻嗪坎地沙坦酯片项目信息
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100685-201903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2000
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%
116.521535041533281534321536011533511534430.08
216.491528821529401529110.03
单位质量响应值RSD%判断
9288.329272.950.12数据可信
加速6月-供试品溶液-2024082321批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
氢氯噻嗪坎地沙坦酯片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.014607214608674609894608304611874609190.04
212.064608734607954608340.02
单位质量响应值RSD%判断
38377.9438211.770.31数据可信
加速6月-供试品溶液-2024082321批-氢氯噻嗪-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%
5min1381887-38188771.58571.1912.2071.5971.1912.20
2446039-44603983.61183.61
3373502-37350270.01470.01
4306628-30662857.47857.48
5406331-40633176.16776.17
6364350-36435068.29868.30
10min1491873-49187392.20291.665.4092.3291.785.41
2518864-51886497.26297.40
3502195-50219594.13794.25
4440484-44048482.56982.67
5485120-48512090.93791.06
6495299-49529992.84592.96
15min1513085-51308596.17996.692.1396.4596.962.15
2525946-52594698.58998.89
3525864-52586498.57498.85
4496904-49690493.14593.38
5512421-51242196.05496.33
6520614-52061497.59097.86
20min1517933-51793397.08798.181.0597.5298.611.06
2527010-52701098.78999.25
3532505-53250599.819100.26
4518672-51867297.22697.61
5522186-52218697.88598.32
6524157-52415798.25498.69
30min1524013-52401398.22799.631.1098.82100.221.07
2528633-52863399.09399.72
3536630-536630100.592101.20
4539887-539887101.203101.75
5528966-52896699.15699.76
6530827-53082799.504100.10
45min1525944-52594498.58999.771.3099.35100.531.27
2526605-52660598.71399.51
3536259-536259100.523101.29
4544137-544137101.999102.72
5530173-53017399.382100.15
6530246-53024699.395100.16
60min1525503-52550398.50699.641.2699.43100.561.23
2526369-52636998.66999.63
3535238-535238100.331101.27
4543168-543168101.818102.71
5529237-52923799.206100.14
6529656-52965699.285100.21
极限1524880-52488098.390100.181.6999.48101.281.66
2527696-52769698.917100.04
3535292-535292100.341101.45
4545412-545412102.238103.30
5545002-545002102.162103.26
6528355-52835599.041100.13
氢氯噻嗪坎地沙坦酯片项目信息
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100685-201903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2000
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%
116.521531951530221532791533371530991531860.09
216.491531731532581532160.04
单位质量响应值RSD%判断
9272.769291.450.15数据可信
加速6月-供试品溶液-2024082321批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
氢氯噻嗪坎地沙坦酯片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.014590354592334591924592594592644591970.03
212.064582804584774583780.04
单位质量响应值RSD%判断
38234.5538008.130.42数据可信
加速6月-供试品溶液-2024082521批-氢氯噻嗪-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%
5min1351932-35193266.27165.5011.4566.2765.5011.45
2303685-30368557.18657.19
3320891-32089160.42660.43
4350362-35036265.97565.98
5419731-41973179.03879.04
6340439-34043964.10764.11
10min1475478-47547889.53588.773.9689.6588.883.97
2440246-44024682.90183.00
3463327-46332787.24787.35
4477140-47714089.84889.96
5496631-49663193.51893.65
6475634-47563489.56589.67
15min1511895-51189596.39396.262.4296.6596.512.42
2490040-49004092.27792.51
3512385-51238596.48596.73
4509618-50961895.96496.22
5514657-51465796.91397.20
6528475-52847599.51599.77
20min1526032-52603299.05598.561.2999.4898.981.30
2512303-51230396.47096.86
3525685-52568598.98999.40
4518290-51829097.59798.02
5528154-52815499.45499.90
6529894-52989499.782100.20
30min1532809-532809100.331100.170.51100.92100.750.53
2528696-52869699.556100.10
3530788-53078899.950100.52
4529973-52997399.797100.38
5533303-533303100.424101.04
6536199-536199100.969101.56
45min1534701-534701100.687100.320.74101.44101.070.74
2528826-52882699.581100.29
3530829-53082999.958100.70
4530805-53080599.954100.70
5531602-531602100.104100.89
6539672-539672101.623102.38
60min1531775-531775100.136100.240.75101.06101.160.76
2529170-52917099.646100.53
3530542-53054299.904100.81
4530010-53001099.804100.72
5532280-532280100.231101.18
6540120-540120101.708102.63
极限1537030-537030101.126100.840.98102.21101.920.97
2532969-532969100.361101.41
3541472-541472101.962103.03
4532334-532334100.241101.32
5528229-52822999.468100.58
6540963-540963101.866102.96
氢氯噻嗪坎地沙坦酯片项目信息
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100685-201903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2000
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%
116.521531081530151528811529411530111529910.06
216.491529451532431530940.14
单位质量响应值RSD%判断
9260.969284.050.18数据可信
加速6月-供试品溶液-2024082521批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
氢氯噻嗪坎地沙坦酯片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.014569734566974573764574084578104572530.10
212.064551704551224551460.01
单位质量响应值RSD%判断
38072.6937740.130.63数据可信
加速6月-供试品溶液-2024082521批-氢氯噻嗪-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%
5min1344349-34434965.21167.0611.3165.2167.0611.32
2346440-34644065.60765.61
3406536-40653676.98876.99
4393058-39305874.43574.44
5337824-33782463.97663.98
6296363-29636356.12456.12
10min1474102-47410289.78390.155.0889.8990.265.09
2471063-47106389.20889.32
3485707-48570791.98192.11
4514716-51471697.47497.60
5470297-47029789.06389.17
6440359-44035983.39383.49
15min1511629-51162996.89097.071.7997.1597.331.81
2509799-50979996.54396.80
3513368-51336897.21997.50
4529142-529142100.206100.49
5510354-51035496.64896.90
6501097-50109794.89595.13
20min1521867-52186798.82999.090.9599.2599.510.96
2517453-51745397.99398.41
3526668-52666899.738100.18
4530855-530855100.531100.98
5519020-51902098.29098.71
6523491-52349199.13699.53
30min1528311-528311100.049100.220.63100.63100.810.63
2527468-52746899.889100.47
3531278-531278100.611101.22
4532761-532761100.892101.51
5523925-52392599.21899.80
6531651-531651100.682101.24
45min1530821-530821100.524100.530.48101.28101.280.49
2531371-531371100.629101.38
3532256-532256100.796101.57
4533222-533222100.979101.77
5525938-52593899.600100.34
6531361-531361100.627101.35
60min1530487-530487100.461100.450.55101.38101.370.56
2531373-531373100.629101.55
3533238-533238100.982101.93
4532235-532235100.792101.75
5524994-52499499.421100.33
6530142-530142100.396101.29
极限1532065-532065100.760101.090.34101.85102.180.34
2534801-534801101.278102.36
3536841-536841101.664102.78
4532869-532869100.912102.04
5532372-532372100.818101.90
6533946-533946101.116102.17
氢氯噻嗪坎地沙坦酯片项目信息
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100685-201903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2000
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%
116.521527301525031526511528841528921527320.11
216.491520391523021521700.13
单位质量响应值RSD%判断
9245.289228.020.14数据可信
加速6月-供试品溶液-2024082521批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
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