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(%)99.70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%
111.784519514523484521974522844521374521830.04
211.784501954495884498920.10
单位质量响应值RSD%判断
38385.6538191.170.36数据可信
加速6月-供试品溶液-2024090121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%
5min1379749-37974971.19771.274.5471.2071.274.54
2355622-35562266.67366.67
3375064-37506470.31870.32
4400822-40082275.14875.15
5370901-37090169.53869.54
6398721-39872174.75474.75
10min1480586-48058690.10290.836.1290.2290.956.11
2501939-50193994.10594.22
3473828-47382888.83588.95
4432485-43248581.08481.21
5504197-50419794.52994.64
6513863-51386396.34196.47
15min1501363-50136393.99794.393.6194.2794.663.61
2512981-51298196.17596.44
3497157-49715793.20993.47
4471819-47181988.45888.72
5514013-51401396.36996.64
6523472-52347298.14298.43
20min1505894-50589494.84795.512.0895.2795.932.08
2516113-51611396.76397.19
3506568-50656894.97395.39
4492025-49202592.24792.65
5513242-51324296.22496.66
6522613-52261397.98198.43
30min1513888-51388896.34696.341.1396.9396.921.14
2516422-51642296.82197.41
3508296-50829695.29795.88
4507463-50746395.14195.70
5513727-51372796.31596.91
6523227-52322798.09698.71
45min1515847-51584796.71396.351.0297.4697.101.03
2514488-51448896.45897.21
3513769-51376996.32397.06
4505376-50537694.75095.47
5512425-51242596.07196.83
6521471-52147197.76798.54
60min1516655-51665596.86496.421.0597.7797.321.06
2518544-51854497.21898.13
3510507-51050795.71296.61
4507056-50705695.06595.94
5511652-51165295.92696.84
6521236-52123697.72398.66
极限1521158-52115897.70999.210.9398.78100.280.92
2534125-534125100.140101.21
3532464-53246499.828100.89
4528193-52819399.027100.06
5526453-52645398.70199.78
6532570-53257099.848100.95
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.642944692949672949042950622950482948900.09
215.602942532936352939440.15
单位质量响应值RSD%判断
18854.8618842.560.05数据可信
加速6月-供试品溶液-2024090121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(%)99.70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%
111.784499164484874493284497784515844498190.26
211.784484154480314482230.07
单位质量响应值RSD%判断
38184.9738049.490.26数据可信
加速6月-供试品溶液-2024090121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%
5min1372008-37200870.05869.006.8070.0669.006.80
2337275-33727563.51763.52
3390083-39008373.46273.46
4399396-39939675.21675.22
5347213-34721365.38965.39
6352294-35229466.34666.35
10min1490393-49039392.35391.402.4692.4791.522.46
2481469-48146990.67390.78
3488915-48891592.07592.20
4488724-48872492.03992.16
5463813-46381387.34887.46
6498738-49873893.92594.04
15min1508289-50828995.72395.221.7195.9995.491.72
2502302-50230294.59694.85
3512616-51261696.53896.81
4510312-51031296.10496.38
5489546-48954692.19492.45
6510749-51074996.18796.45
20min1511868-51186896.39796.491.1596.8396.921.16
2511992-51199296.42196.84
3514568-51456896.90697.34
4518051-51805197.56298.00
5501412-50141294.42894.84
6516322-51632297.23697.66
30min1514027-51402796.80496.971.0497.3997.551.05
2514416-51441696.87797.45
3516037-51603797.18397.78
4521304-52130498.17598.78
5505479-50547995.19495.76
6518033-51803397.55898.15
45min1516246-51624697.22297.100.9497.9797.850.94
2516043-51604397.18497.92
3513570-51357096.71897.48
4521535-52153598.21898.98
5507527-50752795.58096.30
6518748-51874897.69398.45
60min1515183-51518397.02297.170.7997.9498.080.79
2517262-51726297.41398.31
3515637-51563797.10798.03
4520715-52071598.06498.99
5508807-50880795.82196.70
6518161-51816197.58398.50
极限1527331-52733199.31099.650.81100.39100.720.80
2523210-52321098.53399.59
3530163-53016399.843100.93
4534135-534135100.591101.68
5533540-533540100.479101.52
6526419-52641999.138100.22
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.642943172930712935212936852948302938850.24
215.602935932935362935640.02
单位质量响应值RSD%判断
18790.6018818.210.11数据可信
加速6月-供试品溶液-2024090121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(%)99.70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%
111.784493904487594479564492404493294489350.14
211.784477024481874479440.08
单位质量响应值RSD%判断
38109.9338025.810.16数据可信
中间条件6月-供试品溶液-2024090121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%
5min1393417-39341774.18666.558.3074.1966.558.31
2382135-38213572.05972.06
3356024-35602467.13567.13
4329676-32967662.16762.17
5331607-33160762.53162.53
6324769-32476961.24161.24
10min1482744-48274491.03089.392.1891.1589.502.18
2474235-47423589.42689.55
3482940-48294091.06791.18
4458597-45859786.47786.58
5481058-48105890.71290.82
6464632-46463287.61587.72
15min1506993-50699395.60395.551.1195.8895.811.12
2505938-50593895.40495.67
3510565-51056596.27796.54
4499932-49993294.27294.52
5515153-51515397.14297.40
6501676-50167694.60094.85
20min1514032-51403296.93097.470.9097.3797.890.91
2518420-51842097.75898.19
3521532-52153298.34598.77
4511958-51195896.53996.94
5522701-52270198.56598.98
6512699-51269996.67997.08
30min1521642-52164298.36598.640.7498.9699.220.75
2526467-52646799.27599.87
3527300-52730099.432100.02
4519114-51911497.88998.45
5525473-52547399.08899.67
6518447-51844797.76398.33
45min1525314-52531499.05899.260.6099.82100.000.60
2528897-52889799.733100.49
3529243-52924399.799100.55
4523564-52356498.72899.46
5529025-52902599.758100.50
6522181-52218198.46799.20
60min1520666-52066698.18199.440.8999.11100.350.89
2530996-530996100.129101.05
3532534-532534100.419101.34
4524180-52418098.84499.74
5530484-530484100.033100.95
6525088-52508899.01599.91
极限1531409-531409100.20799.870.74101.30100.950.75
2532836-532836100.476101.57
3533463-533463100.594101.68
4526342-52634299.252100.31
5530249-53024999.988101.07
6523505-52350598.71799.78
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.642953012947122947112948442952402949620.10
215.602955562957702956630.06
单位质量响应值RSD%判断
18859.4618952.760.35数据可信
中间条件6月-供试品溶液-2024090121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(%)99.70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%
111.784483284484574481614482124483994483110.03
211.784479024464134471580.24
单位质量响应值RSD%判断
38056.9637959.080.19数据可信
中间条件6月-供试品溶液-2024090121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%
5min1401738-40173875.87567.646.3675.8767.646.36
2354422-35442266.93866.94
3353389-35338966.74366.74
4353270-35327066.72166.72
5333643-33364363.01463.01
6352483-35248366.57266.57
10min1487288-48728892.03289.633.4192.1689.743.41
2480391-48039190.72990.84
3484413-48441391.48991.60
4467404-46740488.27788.39
5444783-44478384.00484.11
6483048-48304891.23191.34
15min1506020-50602095.57095.341.7295.8595.601.72
2506971-50697195.74996.01
3516546-51654697.55897.82
4502627-50262794.92995.19
5489922-48992292.52992.77
6506578-50657895.67595.94
20min1509289-50928996.18797.171.0496.6397.591.03
2512030-51203096.70597.13
3523622-52362298.89499.32
4510151-51015196.35096.77
5514902-51490297.24797.65
6516974-51697497.63998.06
30min1513495-51349596.98298.491.4597.5899.071.44
2515726-51572697.40397.99
3529355-52935599.977100.57
4515330-51533097.32897.91
5530344-530344100.164100.73
6524484-52448499.05799.64
45min1518068-51806897.84598.941.3698.6199.691.35
2517771-51777197.78998.54
3532112-532112100.498101.26
4516928-51692897.63098.37
5531390-531390100.361101.09
6526925-52692599.518100.27
60min1522674-52267498.71599.441.2599.64100.351.24
2520328-52032898.27299.18
3534064-534064100.866101.79
4519296-51929698.07798.98
5533062-533062100.677101.57
6529608-529608100.025100.94
极限1519527-51952798.12199.701.1099.21100.781.08
2526949-52694999.523100.60
3532852-532852100.637101.73
4523847-52384798.937100.00
5535135-535135101.069102.13
6529031-52903199.916101.00
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.642947942949052950692947162948352948640.05
215.602953692945612949650.20
单位质量响应值RSD%判断
18853.2018908.010.21数据可信
中间条件6月-供试品溶液-2024090121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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