坎地氢噻片项目信息
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%
112.694675774675404668674666414666464670540.11
212.714647154642824644980.07
单位质量响应值RSD%判断
36804.8936545.870.50数据可信
供试品溶液-2024082821批-氢氯噻嗪-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%
5min1357496-35749669.97364.705.6869.9764.705.68
2342112-34211266.96266.96
3312672-31267261.19961.20
4340664-34066466.67866.68
5317183-31718362.08262.08
6313202-31320261.30361.30
10min1497430-49743097.36292.073.7097.4892.183.70
2487072-48707295.33595.45
3456264-45626489.30589.41
4460267-46026790.08890.20
5463439-46343990.70990.81
6457997-45799789.64489.75
15min1524712-524712102.70299.911.75102.98100.181.75
2516366-516366101.069101.34
3504359-50435998.71898.97
4504751-50475198.79599.06
5511515-511515100.119100.37
6501129-50112998.08698.34
20min1528418-528418103.428101.591.11103.88102.021.11
2521356-521356102.045102.48
3515947-515947100.987101.40
4516025-516025101.002101.43
5520415-520415101.861102.28
6512016-512016100.217100.63
30min1530293-530293103.795102.480.89104.42103.080.90
2526043-526043102.963103.57
3520610-520610101.899102.48
4522171-522171102.205102.80
5525285-525285102.814103.41
6517008-517008101.194101.78
45min1531017-531017103.936102.830.77104.73103.600.77
2525544-525544102.865103.65
3523516-523516102.468103.22
4525720-525720102.899103.66
5527391-527391103.226103.99
6519016-519016101.587102.34
60min1530015-530015103.740102.790.69104.71103.730.70
2524959-524959102.750103.70
3524042-524042102.571103.50
4526253-526253103.004103.94
5526690-526690103.089104.02
6519140-519140101.612102.53
极限1529415-529415103.623102.610.71104.76103.720.72
2524371-524371102.635103.76
3523388-523388102.443103.54
4524871-524871102.733103.84
5525428-525428102.842103.95
6517995-517995101.387102.48
坎地氢噻片项目信息
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%
116.343025133028383027963028193027913027510.05
216.283022703020923021810.05
单位质量响应值RSD%判断
18528.2118561.490.13数据可信
供试品溶液-2024082821批-坎地沙坦酯-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%
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
坎地氢噻片项目信息
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%
112.694639344640624639744638894637154639150.03
212.714625404627314626360.03
单位质量响应值RSD%判断
36557.5336399.370.31数据可信
供试品溶液-2024083021批-氢氯噻嗪-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%
5min1270318-27031853.19559.116.4053.1959.116.40
2313112-31311261.61661.62
3310623-31062361.12661.13
4317947-31794762.56762.57
5307653-30765360.54260.54
6282700-28270055.63155.63
10min1449786-44978688.51188.843.5588.6088.943.55
2453824-45382489.30689.41
3472771-47277193.03593.14
4465046-46504691.51491.62
5434052-43405285.41585.52
6433241-43324185.25685.35
15min1497807-49780797.96198.701.2098.2098.941.20
2503963-50396399.17399.42
3512362-512362100.825101.08
4500781-50078198.54698.80
5498361-49836198.07098.31
6495996-49599697.60597.84
20min1516931-516931101.725101.740.58102.12102.150.58
2515043-515043101.353101.77
3521315-521315102.587103.01
4512547-512547100.862101.28
5517939-517939101.923102.33
6518245-518245101.983102.38
30min1523494-523494103.016102.920.73103.59103.500.72
2519081-519081102.148102.73
3525878-525878103.485104.08
4517565-517565101.849102.44
5525481-525481103.407103.98
6526464-526464103.601104.17
45min1524345-524345103.184103.170.74103.92103.920.73
2520543-520543102.435103.19
3527510-527510103.806104.57
4518670-518670102.067102.83
5526730-526730103.653104.40
6527817-527817103.867104.61
60min1523256-523256102.969103.060.81103.88103.990.80
2519485-519485102.227103.15
3527075-527075103.721104.66
4518165-518165101.967102.90
5525730-525730103.456104.38
6528672-528672104.035104.95
极限1523162-523162102.951102.980.88104.04104.070.87
2518767-518767102.086103.18
3526105-526105103.530104.64
4517114-517114101.761102.86
5525681-525681103.446104.54
6528920-528920104.084105.17
坎地氢噻片项目信息
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%
116.343022493025163023323024633022143023550.05
216.283015803016993016400.03
单位质量响应值RSD%判断
18503.9818528.260.10数据可信
供试品溶液-2024083021批-坎地沙坦酯-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%
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
坎地氢噻片项目信息
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%
112.694635034631194635044633594636824634330.05
212.714609884611094610480.02
单位质量响应值RSD%判断
36519.5436274.430.48数据可信
供试品溶液-2024090121批-氢氯噻嗪-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%
5min1285126-28512656.23557.782.7656.2357.782.76
2290223-29022357.24057.24
3294466-29446658.07758.08
4284576-28457656.12656.13
5297794-29779458.73358.73
6305629-30562960.27860.28
10min1440864-44086486.95086.443.4987.0486.543.49
2416781-41678182.20182.30
3445937-44593787.95188.05
4454670-45467089.67389.77
5422321-42232183.29383.39
6449043-44904388.56488.66
15min1496421-49642197.90897.931.5598.1598.171.55
2500566-50056698.72598.96
3507523-507523100.097100.34
4493544-49354497.34097.58
5484324-48432495.52295.76
6496792-49679297.98198.23
20min1514109-514109101.396101.240.94101.80101.640.93
2517048-517048101.976102.37
3520483-520483102.653103.06
4508344-508344100.259100.66
5510964-510964100.776101.17
6508996-508996100.388100.80
30min1518078-518078102.179102.360.71102.75102.930.71
2521712-521712102.896103.46
3524972-524972103.539104.12
4517587-517587102.082102.65
5516114-516114101.792102.36
6515431-515431101.657102.24
45min1518383-518383102.239102.650.66102.98103.390.66
2523082-523082103.166103.90
3526027-526027103.747104.50
4519350-519350102.430103.17
5516777-516777101.923102.66
6519073-519073102.375103.12
60min1517754-517754102.115102.540.66103.03103.450.65
2522557-522557103.063103.97
3525366-525366103.617104.54
4519165-519165102.394103.31
5516393-516393101.847102.75
6518203-518203102.204103.12
极限1516771-516771101.921102.330.59103.00103.410.60
2521390-521390102.832103.91
3523596-523596103.267104.37
4517846-517846102.133103.22
5515428-515428101.657102.73
6518001-518001102.164103.25
坎地氢噻片项目信息
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%
116.343024413027593021343023773022383023900.08
216.283009993009143009560.02
单位质量响应值RSD%判断
18506.1218486.240.08数据可信
供试品溶液-2024090121批-坎地沙坦酯-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%
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
坎地氢噻片项目信息
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%
112.694621524617244621174618984620194619820.04
212.714606614605944606280.02
单位质量响应值RSD%判断
36405.2036241.380.32数据可信
供试品溶液-516246批-氢氯噻嗪-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%
5min1257459-25745950.88149.778.0550.8849.778.05
2261555-26155551.69051.69
3220154-22015443.50843.51
4279160-27916055.16955.17
5238658-23865847.16547.17
6253915-25391550.18050.18
10min1419704-41970482.94580.966.5983.0381.046.59
2412717-41271781.56481.65
3360722-36072271.28871.36
4442768-44276887.50387.59
5414772-41477281.97082.05
6407172-40717280.46880.55
15min1481567-48156795.17091.136.1795.3991.356.17
2464447-46444791.78792.01
3413226-41322681.66481.86
4487078-48707896.25996.50
5478209-47820994.50794.72
6442356-44235687.42187.64
20min1502919-50291999.39095.734.6299.7796.104.62
2486412-48641296.12896.50
3451213-45121389.17289.50
4503748-50374899.55499.95
5499163-49916398.64899.02
6462997-46299791.50091.86
30min1517209-517209102.21499.922.74102.76100.452.75
2515469-515469101.870102.41
3491814-49181497.19597.67
4511841-511841101.153101.72
5512675-512675101.318101.86
6484556-48455695.76196.28
45min1518417-518417102.453101.820.48103.17102.520.50
2517672-517672102.306103.01
3512625-512625101.308101.95
4513502-513502101.481102.21
5515783-515783101.932102.64
6513269-513269101.435102.11
60min1517349-517349102.242102.080.26103.13102.940.24
2517578-517578102.287103.16
3517177-517177102.208103.01
4514351-514351101.649102.55
5515480-515480101.872102.75
6517271-517271102.226103.07
极限1516656-516656102.105102.180.35103.16103.220.33
2517355-517355102.243103.29
3516977-516977102.168103.15
4514299-514299101.639102.71
5517093-517093102.191103.24
6519833-519833102.733103.75
坎地氢噻片项目信息
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%
116.343018953018633017093017943017173017960.03
216.283011393011033011210.01
单位质量响应值RSD%判断
18469.7718496.380.11数据可信
供试品溶液-516246批-坎地沙坦酯-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%
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
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