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%
111.784534394527174518284524294523214525470.14
211.784508214509304508760.02
单位质量响应值RSD%判断
38416.5538274.700.27数据可信
加速6月-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%
5min1364047-36404768.15166.4915.1668.1566.4915.16
2321105-32110560.11260.11
3314269-31426958.83258.83
4453473-45347384.89284.89
5312651-31265158.52958.53
6365490-36549068.42168.42
10min1472710-47271088.49387.886.2188.6188.006.22
2459956-45995686.10586.21
3433864-43386481.22181.32
4510635-51063595.59395.73
5445493-44549383.39883.50
6494080-49408092.49392.61
15min1508561-50856195.20495.132.6395.4795.392.64
2514039-51403996.23096.47
3487025-48702591.17391.41
4518836-51883697.12897.43
5498280-49828093.28093.52
6522262-52226297.76998.04
20min1522166-52216697.75197.461.3798.1797.881.38
2526173-52617398.50198.91
3511707-51170795.79396.18
4522997-52299797.90798.37
5512081-51208195.86396.26
6528518-52851898.94099.37
30min1529127-52912799.05498.420.9199.6499.000.92
2528843-52884399.00199.57
3524431-52443198.17598.72
4525653-52565398.40499.03
5516932-51693296.77197.32
6529319-52931999.09099.69
45min1529833-52983399.18698.570.9299.9399.310.93
2528657-52865798.96699.70
3526307-52630798.52699.24
4526119-52611998.49199.28
5517413-51741396.86197.57
6530767-53076799.361100.12
60min1530527-53052799.31698.450.95100.2399.350.95
2527744-52774498.79599.69
3527026-52702698.66199.53
4524463-52446398.18199.14
5516615-51661596.71297.59
6528916-52891699.01599.94
极限1529205-52920599.06998.441.05100.1599.511.06
2528053-52805398.85399.92
3526691-52669198.59899.64
4526008-52600898.47099.59
5515036-51503696.41697.45
6529941-52994199.207100.30
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%
115.642944282950752945202942602946872945940.11
215.602944372945902945140.04
单位质量响应值RSD%判断
18835.9318879.100.17数据可信
加速6月-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
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%
111.784526944521334514064519564509604518300.15
211.784514264505244509750.15
单位质量响应值RSD%判断
38355.6938283.110.14数据可信
加速6月-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%
5min1357091-35709166.89467.328.2966.8967.328.29
2331987-33198762.19162.19
3337822-33782263.28463.28
4339998-33999863.69263.69
5381763-38176371.51671.52
6407652-40765276.36676.37
10min1477918-47791889.52990.121.2289.6490.231.23
2487277-48727791.28291.39
3473417-47341788.68688.79
4477061-47706189.36889.47
5487774-48777491.37591.49
6483056-48305690.49190.62
15min1517414-51741496.92896.061.3397.1996.321.32
2517888-51788897.01697.27
3516653-51665396.78597.04
4509456-50945695.43795.69
5514810-51481096.44096.71
6500442-50044293.74894.03
20min1524400-52440098.23697.351.4898.6697.781.47
2521806-52180697.75098.17
3526032-52603298.54298.96
4518810-51881097.18997.60
5522239-52223997.83198.26
6504884-50488494.58095.01
30min1526354-52635498.60297.951.4199.1998.541.39
2523634-52363498.09398.67
3530619-53061999.40199.98
4523118-52311897.99698.57
5524553-52455398.26598.86
6508993-50899395.35095.94
45min1527376-52737698.79498.081.3599.5498.831.34
2522783-52278397.93398.68
3530907-53090799.455100.20
4524722-52472298.29799.04
5525278-52527898.40199.16
6510393-51039395.61296.36
60min1526767-52676798.68098.111.2999.5999.021.28
2523486-52348698.06598.97
3530223-53022399.327100.24
4524602-52460298.27499.18
5526394-52639498.61099.53
6510836-51083695.69596.61
极限1526370-52637098.60598.750.4099.6899.830.40
2525340-52534098.41299.48
3531046-53104699.481100.56
4525423-52542398.42899.50
5527217-52721798.76499.85
6527511-52751198.81999.89
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%
115.642957532954132949292949822949662952090.13
215.602965752959592962670.15
单位质量响应值RSD%判断
18875.2618991.470.44数据可信
加速6月-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
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%
111.784470434486874493354494994485734486270.22
211.784477844467514472680.17
单位质量响应值RSD%判断
38083.7937968.420.22数据可信
中间条件6月-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%
5min1343823-34382364.90662.869.0264.9162.869.03
2336931-33693163.60463.60
3324418-32441861.24261.24
4305721-30572157.71357.71
5302764-30276457.15557.15
6384401-38440172.56672.57
10min1469412-46941288.61489.793.2788.7289.893.28
2480688-48068890.74290.85
3487824-48782492.08992.19
4457780-45778086.41886.51
5460950-46095087.01687.11
6497061-49706193.83393.95
15min1509252-50925296.13597.641.0996.3997.901.09
2519562-51956298.08198.34
3526037-52603799.30399.56
4514006-51400697.03297.27
5517293-51729397.65397.89
6517320-51732097.65897.93
20min1522364-52236498.61099.180.9499.0399.600.93
2527421-52742199.56499.99
3530827-530827100.207100.63
4529113-52911399.884100.29
5525355-52535599.17499.58
6517378-51737897.66998.11
30min1526548-52654899.400100.001.0899.98100.591.07
2529948-529948100.041100.63
3533324-533324100.679101.27
4538461-538461101.649102.22
5528193-52819399.710100.28
6521955-52195598.53399.14
45min1527704-52770499.61899.961.19100.36100.711.18
2529957-529957100.043100.80
3532651-532651100.552101.31
4539373-539373101.821102.56
5526713-52671399.431100.17
6520601-52060198.27799.04
60min1527849-52784999.645100.160.77100.56101.080.77
2528523-52852399.772100.69
3532865-532865100.592101.52
4537936-537936101.549102.46
5527903-52790399.655100.56
6528343-52834399.738100.67
极限1529257-52925799.911100.051.02100.99101.131.01
2529560-52956099.968101.05
3533436-533436100.700101.79
4538369-538369101.631102.71
5526143-52614399.323100.39
6523164-52316498.76199.86
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%
115.642937342950542958752959842950462951390.31
215.602956592953352954970.08
单位质量响应值RSD%判断
18870.7818942.120.27数据可信
中间条件6月-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
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%
111.784482574479874482724478754474504479680.08
211.784470414453674462040.27
单位质量响应值RSD%判断
38027.8437878.100.28数据可信
中间条件6月-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%
5min1409783-40978377.50668.9413.5777.5168.9413.57
2394406-39440674.59874.60
3355887-35588767.31267.31
4309741-30974158.58458.58
5413971-41397178.29978.30
6303239-30323957.35557.35
10min1499975-49997594.56590.635.0694.6990.755.07
2493273-49327393.29893.42
3489233-48923392.53492.65
4461601-46160187.30787.40
5493070-49307093.25993.39
6437951-43795182.83482.93
15min1522351-52235198.79897.062.7099.0897.332.71
2516879-51687997.76398.04
3520994-52099498.54198.81
4512271-51227196.89197.13
5520660-52066098.47898.76
6485905-48590591.90492.14
20min1526477-52647799.57899.481.28100.0399.911.29
2524612-52461299.22599.67
3533963-533963100.994101.42
4526684-52668499.617100.02
5530074-530074100.258100.71
6514079-51407997.23397.62
30min1531793-531793100.583100.610.73101.20101.200.73
2526623-52662399.606100.21
3538021-538021101.761102.36
4532445-532445100.707101.28
5533293-533293100.867101.48
6529344-529344100.120100.67
45min1530270-530270100.295100.720.72101.08101.480.72
2528421-52842199.946100.72
3539282-539282102.000102.77
4533046-533046100.820101.56
5533496-533496100.905101.69
6530668-530668100.371101.09
60min1529243-529243100.101100.550.66101.05101.480.66
2528292-52829299.921100.86
3537529-537529101.668102.61
4532313-532313100.682101.59
5533041-533041100.819101.77
6529261-529261100.104100.99
极限1529896-529896100.225100.600.73101.34101.700.74
2527867-52786799.841100.95
3538083-538083101.773102.88
4532188-532188100.658101.73
5534509-534509101.097102.22
6528771-528771100.012101.06
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%
115.642956152961282963852959442953622958870.14
215.602954002941802947900.30
单位质量响应值RSD%判断
18918.6118896.790.09数据可信
中间条件6月-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
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