坎地沙坦酯氢氯噻嗪片项目信息
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%
112.014581124581234581784583664579474581450.04
212.064567214565294566250.03
单位质量响应值RSD%判断
38146.9637862.770.53数据可信
中间条件6月-供试品溶液-2024082321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%
5min1267814-26781450.58654.196.8350.5954.196.83
2296574-29657456.01856.02
3272532-27253251.47751.48
4298859-29885956.45056.45
5315653-31565359.62259.62
6270010-27001051.00051.00
10min1425605-42560580.39084.403.7680.4784.493.76
2455382-45538286.01486.11
3436590-43659082.46582.55
4459660-45966086.82286.92
5468674-46867488.52588.62
6435140-43514082.19182.28
15min1504394-50439495.27295.991.5695.4996.221.56
2504696-50469695.32995.57
3503031-50303195.01495.24
4508164-50816495.98496.22
5523940-52394098.96499.21
6505080-50508095.40195.62
20min1531550-531550100.40199.640.58100.78100.030.58
2524289-52428999.03099.43
3526944-52694499.53199.91
4526855-52685599.51499.91
5530774-530774100.255100.67
6524747-52474799.11699.50
30min1536426-536426101.322100.800.30101.87101.360.30
2532830-532830100.643101.20
3534352-534352100.930101.48
4532150-532150100.514101.08
5533731-533731100.813101.39
6532489-532489100.579101.12
45min1536656-536656101.366100.810.31102.08101.540.30
2533030-533030100.681101.41
3534209-534209100.903101.62
4532156-532156100.516101.25
5533772-533772100.821101.57
6532466-532466100.574101.29
60min1537076-537076101.445100.740.40102.33101.630.40
2532263-532263100.536101.43
3534301-534301100.921101.80
4531670-531670100.424101.32
5533190-533190100.711101.63
6531446-531446100.381101.26
极限1536252-536252101.289100.560.41102.34101.620.40
2531594-531594100.409101.47
3533304-533304100.732101.78
4530093-530093100.126101.19
5531855-531855100.459101.54
6531317-531317100.357101.41
坎地沙坦酯氢氯噻嗪片项目信息
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%
116.521533351534861534941534861534451534490.05
216.491535191537751536470.12
单位质量响应值RSD%判断
9288.689317.590.22数据可信
中间条件6月-供试品溶液-2024082321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%
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
坎地沙坦酯氢氯噻嗪片项目信息
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%
112.014561204559064556444559004558804558900.04
212.064539254539554539400.01
单位质量响应值RSD%判断
37959.2037640.130.60数据可信
中间条件6月-供试品溶液-2024082321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%
5min1332537-33253763.15257.067.3063.1557.067.30
2305883-30588358.09058.09
3283855-28385553.90753.91
4273715-27371551.98151.98
5290417-29041755.15355.15
6316345-31634560.07760.08
10min1445574-44557484.61984.333.8384.7284.423.83
2457037-45703786.79686.89
3434939-43493982.59982.69
4416966-41696679.18679.27
5444366-44436684.38984.48
6465308-46530888.36788.47
15min1497745-49774594.52794.952.7494.7795.182.74
2506972-50697296.27996.52
3505263-50526395.95496.18
4473777-47377789.97590.19
5503790-50379095.67595.91
6512287-51228797.28897.54
20min1514680-51468097.74397.991.5398.1598.391.54
2522629-52262999.25299.65
3522170-52217099.16599.55
4501202-50120295.18395.55
5516374-51637498.06498.46
6518923-51892398.54998.96
30min1520619-52061998.87199.200.8199.4499.760.81
2529195-529195100.499101.07
3524762-52476299.657100.21
4517264-51726498.23498.76
5522470-52247099.22299.78
6519810-51981098.71799.29
45min1522182-52218299.16799.300.7599.90100.020.75
2529447-529447100.547101.28
3524755-52475599.656100.37
4518865-51886598.53899.23
5522597-52259799.24699.97
6519309-51930998.62299.36
60min1520532-52053298.85499.180.7399.75100.070.73
2528985-528985100.459101.36
3523481-52348199.414100.30
4519312-51931298.62299.48
5522762-52276299.278100.16
6518523-51852398.47399.38
极限1520768-52076898.89999.680.5199.96100.740.51
2527511-527511100.180101.25
3522663-52266399.259100.31
4525719-52571999.839100.86
5525393-52539399.777100.83
6527320-527320100.143101.21
坎地沙坦酯氢氯噻嗪片项目信息
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%
116.521537871538001535261538601537131537370.09
216.491534501533971534240.03
单位质量响应值RSD%判断
9306.119304.060.02数据可信
中间条件6月-供试品溶液-2024082321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%
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
坎地沙坦酯氢氯噻嗪片项目信息
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%
112.014544554545684544414542784541784543840.04
212.064541644543044542340.03
单位质量响应值RSD%判断
37833.8137664.510.32数据可信
中间条件6月-供试品溶液-2024082521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%
5min1329429-32942962.64562.3015.2062.6462.3015.20
2331620-33162063.06163.06
3270598-27059851.45751.46
4348528-34852866.27766.28
5406853-40685377.36877.37
6278561-27856152.97252.97
10min1457260-45726086.95388.026.3087.0688.126.31
2478521-47852190.99691.10
3431423-43142382.04082.13
4474427-47442790.21890.33
5505161-50516196.06296.19
6430352-43035281.83681.92
15min1514399-51439997.81997.872.6198.0798.122.63
2524928-52492899.821100.08
3496421-49642194.40094.62
4517496-51749698.40898.67
5532190-532190101.202101.49
6502628-50262895.58095.81
20min1531446-531446101.061100.931.21101.47101.341.23
2536287-536287101.981102.40
3522902-52290299.43699.82
4527351-527351100.282100.71
5539871-539871102.663103.12
6526610-526610100.141100.52
30min1534810-534810101.700101.720.98102.28102.311.00
2539525-539525102.597103.19
3530608-530608100.901101.45
4529802-529802100.748101.34
5542824-542824103.224103.85
6532064-532064101.178101.73
45min1533158-533158101.386101.600.99102.14102.351.01
2538497-538497102.401103.17
3531131-531131101.001101.71
4528927-528927100.582101.34
5542679-542679103.197104.00
6531157-531157101.006101.73
60min1531355-531355101.043101.281.08101.96102.201.09
2537997-537997102.306103.24
3528754-528754100.549101.43
4527320-527320100.276101.20
5541283-541283102.931103.90
6528807-528807100.559101.45
极限1530384-530384100.859101.050.92101.95102.140.93
2535511-535511101.834102.94
3528320-528320100.466101.52
4526419-526419100.105101.20
5539012-539012102.499103.64
6528643-528643100.528101.58
坎地沙坦酯氢氯噻嗪片项目信息
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%
116.521538021539721533921535661538671537200.16
216.491535351539921537640.22
单位质量响应值RSD%判断
9305.089324.680.15数据可信
中间条件6月-供试品溶液-2024082521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%
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
坎地沙坦酯氢氯噻嗪片项目信息
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%
112.014526264527574532304538574537914532520.13
212.064498024497564497790.01
单位质量响应值RSD%判断
37739.5537295.110.84数据可信
中间条件6月-供试品溶液-2024082521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%
5min1259150-25915049.58659.049.6049.5959.049.60
2335119-33511964.12264.12
3333528-33352863.81863.82
4293743-29374356.20556.21
5302336-30233657.85057.85
6327375-32737562.64162.64
10min1435416-43541683.31388.016.2483.4088.116.24
2488796-48879693.52793.63
3489030-48903093.57293.68
4420202-42020280.40280.50
5452329-45232986.55086.65
6473963-47396390.68990.79
15min1504028-50402896.44296.723.9296.6696.963.92
2519276-51927699.35999.62
3525313-525313100.515100.78
4471367-47136790.19290.42
5496354-49635494.97495.21
6516500-51650098.82899.08
20min1533699-533699102.119100.152.54102.50100.562.54
2526242-526242100.692101.12
3530088-530088101.428101.86
4498524-49852495.38995.77
5519361-51936199.37699.77
6532522-532522101.894102.31
30min1540186-540186103.360101.771.17103.91102.341.17
2530149-530149101.440102.04
3532251-532251101.842102.44
4521919-52191999.865100.40
5530551-530551101.517102.08
6536222-536222102.602103.19
45min1538617-538617103.060101.810.76103.78102.550.76
2530505-530505101.508102.27
3532145-532145101.822102.59
4526970-526970100.832101.54
5529886-529886101.390102.12
6534302-534302102.235103.00
60min1537170-537170102.783101.690.64103.68102.600.64
2529230-529230101.264102.20
3531086-531086101.619102.56
4529211-529211101.260102.13
5528321-528321101.090101.99
6533712-533712102.122103.05
极限1536437-536437102.643101.610.58103.71102.690.56
2529364-529364101.290102.39
3529955-529955101.403102.51
4531522-531522101.703102.74
5527503-527503100.934102.00
6531333-531333101.666102.77
坎地沙坦酯氢氯噻嗪片项目信息
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%
116.521533331532801535141538151536811535250.15
216.491523391524891524140.07
单位质量响应值RSD%判断
9293.289242.810.39数据可信
中间条件6月-供试品溶液-2024082521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%
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-
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6-0.0000.00
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