坎地沙坦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%
111.834412564411114412134410474410744411400.03
211.944410764408704409730.04
单位质量响应值RSD%判断
37289.9436932.410.69数据可信
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%
5min1352874-35287468.25875.878.6168.2675.888.61
2386670-38667074.79574.80
3402301-40230177.81977.82
4390038-39003875.44775.45
5370073-37007371.58571.58
6451547-45154787.34587.34
10min1449495-44949586.94895.064.9487.0695.184.94
2493489-49348995.45895.58
3506909-50690998.05398.18
4500516-50051696.81796.94
5479898-47989892.82992.95
6518243-518243100.246100.39
15min1480238-48023892.89499.563.3993.1599.853.39
2519342-519342100.458100.74
3523541-523541101.271101.56
4522392-522392101.048101.34
5515141-51514199.64699.92
6527646-527646102.065102.38
20min1501053-50105396.921101.072.1097.33101.522.11
2526293-526293101.803102.25
3529955-529955102.511102.97
4524056-524056101.370101.83
5523190-523190101.203101.64
6530537-530537102.624103.11
30min1517817-517817100.163102.241.19100.74102.861.21
2532766-532766103.055103.68
3532249-532249102.955103.59
4524137-524137101.386102.01
5530697-530697102.655103.26
6533640-533640103.224103.88
45min1526490-526490101.841102.690.86102.58103.470.86
2534612-534612103.412104.20
3532564-532564103.016103.82
4523887-523887101.338102.13
5533282-533282103.155103.93
6534331-534331103.358104.18
60min1529364-529364102.397102.730.79103.31103.690.79
2533616-533616103.220104.18
3532730-532730103.048104.02
4523342-523342101.232102.19
5533094-533094103.119104.07
6534397-534397103.371104.37
极限1531421-531421102.795103.760.83103.88104.890.84
2540454-540454104.542105.68
3535972-535972103.675104.82
4532227-532227102.951104.08
5535706-535706103.624104.75
6542631-542631104.963106.13
坎地沙坦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%
116.171510191509841511571510881509341510360.06
216.221509921511841510880.09
单位质量响应值RSD%判断
9340.519314.920.20数据可信
供试品溶液-2024082321批-坎地沙坦-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
坎地沙坦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%
111.834399924394234396564396034395884396520.05
211.944383424391774387600.14
单位质量响应值RSD%判断
37164.1636747.070.80数据可信
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%
5min1359012-35901269.73867.145.4069.7467.145.40
2333902-33390264.86064.86
3328154-32815463.74463.74
4329963-32996364.09564.10
5375100-37510072.86372.86
6347710-34771067.54367.54
10min1478867-47886793.02092.471.9693.1492.581.96
2476781-47678192.61592.72
3457725-45772588.91389.02
4482810-48281093.78693.89
5477508-47750892.75692.88
6482379-48237993.70293.81
15min1511224-51122499.30599.791.6399.58100.061.63
2512367-51236799.52799.79
3499291-49929196.98797.24
4522510-522510101.498101.76
5516252-516252100.282100.56
6520685-520685101.143101.41
20min1518399-518399100.699101.951.68101.14102.381.68
2523637-523637101.716102.14
3511094-51109499.28099.70
4531705-531705103.284103.72
5532797-532797103.496103.94
6531386-531386103.222103.66
30min1524582-524582101.900103.021.54102.50103.621.54
2532169-532169103.374103.97
3516719-516719100.373100.95
4536087-536087104.135104.74
5537701-537701104.448105.06
6534856-534856103.896104.51
45min1527070-527070102.383103.451.48103.16104.221.48
2535685-535685104.057104.83
3518993-518993100.814101.56
4538117-538117104.529105.31
5537931-537931104.493105.28
6537487-537487104.407105.19
60min1524739-524739101.931103.371.49102.88104.321.49
2534816-534816103.888104.83
3519832-519832100.977101.89
4538448-538448104.594105.55
5538242-538242104.554105.52
6536839-536839104.281105.24
极限1532206-532206103.381103.820.72104.50104.940.73
2534569-534569103.840104.96
3528041-528041102.572103.66
4538064-538064104.519105.65
5537722-537722104.453105.59
6536262-536262104.169105.30
坎地沙坦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%
116.171513331511061511701510921511121511630.07
216.221506831509661508240.14
单位质量响应值RSD%判断
9348.369298.640.38数据可信
供试品溶液-2024082321批-坎地沙坦-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
坎地沙坦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%
111.834379734381374391814386884388404385640.12
211.944357904361294359600.06
单位质量响应值RSD%判断
37072.1936512.561.08数据可信
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%
5min1402127-40212778.46273.429.2278.4673.429.22
2349837-34983768.25968.26
3413125-41312580.60880.61
4352599-35259968.79868.80
5406343-40634379.28479.28
6333624-33362465.09665.10
10min1495102-49510296.60396.013.8996.7396.143.90
2486133-48613394.85394.97
3516714-516714100.820100.95
4473376-47337692.36492.48
5510894-51089499.68499.82
6470265-47026591.75791.87
15min1515611-515611100.604102.101.76100.90102.381.76
2516759-516759100.828101.10
3535639-535639104.512104.81
4530273-530273103.465103.73
5527912-527912103.005103.30
6513464-513464100.186100.45
20min1525946-525946102.621103.891.57103.08104.341.57
2526550-526550102.739103.18
3540025-540025105.368105.84
4544383-544383106.218106.66
5533635-533635104.121104.59
6524175-524175102.275102.70
30min1532252-532252103.851104.671.65104.48105.301.65
2529957-529957103.404104.01
3543325-543325106.012106.66
4549830-549830107.281107.90
5537164-537164104.810105.45
6526205-526205102.672103.27
45min1534152-534152104.222104.971.64105.03105.771.64
2531069-531069103.621104.40
3545273-545273106.392107.22
4551208-551208107.550108.35
5538107-538107104.994105.81
6528219-528219103.064103.83
60min1534247-534247104.241104.961.66105.22105.941.66
2531463-531463103.697104.65
3544960-544960106.331107.34
4551145-551145107.538108.51
5538595-538595105.089106.08
6527227-527227102.871103.81
极限1536894-536894104.757105.141.66105.91106.291.66
2531403-531403103.686104.81
3549020-549020107.123108.31
4549396-549396107.196108.35
5538636-538636105.097106.27
6527708-527708102.965104.08
坎地沙坦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%
116.171509231509871513191510551510061510580.11
216.221503041501931502480.06
单位质量响应值RSD%判断
9341.879263.130.60数据可信
供试品溶液-2024082521批-坎地沙坦-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
坎地沙坦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%
111.834379454378264376194379154378114378230.03
211.944358944359934359440.02
单位质量响应值RSD%判断
37009.5536511.220.96数据可信
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%
5min1317645-31764562.03166.245.5262.0366.245.53
2352662-35266268.86968.87
3340984-34098466.58966.59
4364995-36499571.27871.28
5318328-31832862.16462.16
6340456-34045666.48666.49
10min1448375-44837587.56192.525.4387.6692.645.42
2491999-49199996.08096.19
3489364-48936495.56595.68
4493472-49347296.36796.49
5434303-43430384.81384.92
6485248-48524894.76194.87
15min1491081-49108195.900100.592.9896.15100.852.98
2521373-521373101.816102.09
3528152-528152103.140103.41
4526255-526255102.769103.05
5500827-50082797.80498.05
6522783-522783102.091102.36
20min1511512-51151299.890103.281.83100.30103.711.84
2530636-530636103.625104.07
3537322-537322104.931105.37
4537168-537168104.901105.35
5525038-525038102.532102.94
6531499-531499103.793104.23
30min1531395-531395103.773104.830.96104.35105.440.97
2535074-535074104.492105.11
3543028-543028106.045106.66
4543049-543049106.049106.67
5532143-532143103.919104.50
6536201-536201104.712105.32
45min1534721-534721104.423105.060.91105.17105.840.92
2535455-535455104.566105.36
3544410-544410106.315107.11
4543940-543940106.223107.03
5533397-533397104.164104.92
6536087-536087104.689105.48
60min1535013-535013104.480105.091.08105.40106.051.09
2534848-534848104.447105.41
3545141-545141106.458107.43
4545296-545296106.488107.47
5531435-531435103.781104.71
6537199-537199104.907105.87
极限1534933-534933104.464105.360.98105.56106.491.00
2539934-539934105.441106.58
3545143-545143106.458107.61
4545760-545760106.578107.74
5532656-532656104.019105.12
6538633-538633105.187106.32
坎地沙坦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%
116.171510021510101509791510631510311510170.03
216.221502731503811503270.06
单位质量响应值RSD%判断
9339.339268.000.55数据可信
供试品溶液-2024082521批-坎地沙坦-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
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