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%
111.524476384471524468604468344466834470330.09
211.634465014472354468680.12
单位质量响应值RSD%判断
38804.9538423.730.70数据可信
供试品溶液-2024082721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%
5min1385776-38577671.71768.7412.1671.7268.7412.16
2380751-38075170.78370.78
3411066-41106676.41976.42
4299741-29974155.72355.72
5331123-33112361.55761.56
6409979-40997976.21776.22
10min1502043-50204393.33291.105.2393.4591.225.24
2498009-49800992.58292.70
3505486-50548693.97294.10
4453973-45397384.39684.49
5462744-46274486.02686.13
6518022-51802296.30396.43
15min1531991-53199198.89998.212.1699.1798.482.17
2528023-52802398.16298.43
3542721-542721100.894101.18
4515096-51509695.75995.99
5515018-51501895.74495.99
6536910-53691099.814100.10
20min1538819-538819100.169100.531.27100.61100.961.28
2534277-53427799.32499.76
3553276-553276102.856103.31
4535270-53527099.50999.90
5540921-540921100.560100.97
6541907-541907100.743101.20
30min1540150-540150100.416101.411.36101.02102.011.35
2536011-53601199.647100.25
3557330-557330103.610104.23
4548959-548959102.054102.61
5545862-545862101.478102.05
6544691-544691101.260101.88
45min1539516-539516100.298101.391.46101.07102.161.46
2534988-53498899.457100.22
3557970-557970103.729104.53
4549325-549325102.122102.85
5545775-545775101.462102.20
6544898-544898101.299102.09
60min1538719-538719100.150101.221.40101.09102.151.39
2534953-53495399.450100.38
3556661-556661103.486104.45
4548374-548374101.945102.84
5544151-544151101.160102.07
6543822-543822101.099102.06
极限1537773-53777399.974101.041.40101.08102.141.40
2533895-53389599.253100.35
3555654-555654103.299104.44
4547413-547413101.766102.84
5543095-543095100.964102.04
6543149-543149100.974102.10
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%
116.031539821538801540071540521540151539870.05
216.111543881543921543900.01
单位质量响应值RSD%判断
9606.189583.490.17数据可信
供试品溶液-2024082721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%
111.524446274445924441304440574442594443330.06
211.634424374427494425930.05
单位质量响应值RSD%判断
38570.5738056.150.95数据可信
供试品溶液-2024082721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%
5min1364324-36432468.26364.297.0668.2664.287.06
2315618-31561859.13759.14
3310362-31036258.15258.15
4347930-34793065.19165.19
5355351-35535166.58266.58
6365017-36501768.39368.39
10min1492960-49296092.36590.952.7792.4891.062.77
2475686-47568689.12989.23
3462368-46236886.63386.73
4491938-49193892.17492.28
5495845-49584592.90693.02
6493539-49353992.47492.59
15min1536128-536128100.45499.531.14100.7299.791.14
2532623-53262399.797100.04
3521265-52126597.66997.91
4529938-52993899.29499.56
5538256-538256100.852101.12
6529092-52909299.13599.40
20min1544731-544731102.066101.280.84102.50101.700.84
2542927-542927101.728102.14
3538795-538795100.953101.36
4537966-537966100.798101.23
5545132-545132102.141102.57
6533547-53354799.970100.40
30min1546221-546221102.345101.670.88102.95102.270.87
2544675-544675102.055102.64
3543030-543030101.747102.32
4541117-541117101.388101.98
5546865-546865102.465103.07
6533969-533969100.049100.65
45min1545179-545179102.149101.640.87102.93102.400.87
2544003-544003101.929102.68
3543226-543226101.784102.53
4540626-540626101.296102.06
5547609-547609102.605103.38
6534025-534025100.060100.83
60min1545192-545192102.152101.450.92103.10102.380.91
2542722-542722101.689102.61
3541999-541999101.554102.47
4539631-539631101.110102.04
5546483-546483102.394103.34
6532622-53262299.797100.73
极限1543417-543417101.819101.230.94102.94102.330.93
2542202-542202101.592102.68
3540162-540162101.209102.29
4538433-538433100.885101.99
5546008-546008102.305103.42
6531467-53146799.580100.68
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%
116.031539031537811536031536241536721537170.09
216.111534121537391535760.16
单位质量响应值RSD%判断
9589.339532.960.42数据可信
供试品溶液-2024082721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%
111.524439824444774442094440314439734441340.05
211.634417514419504418500.04
单位质量响应值RSD%判断
38553.3037992.261.04数据可信
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%
5min1293028-29302854.96359.065.9654.9659.065.96
2317044-31704459.46859.47
3295132-29513255.35855.36
4330024-33002461.90261.90
5313482-31348258.79958.80
6340469-34046963.86163.86
10min1457030-45703085.72589.283.0685.8289.383.06
2484318-48431890.84390.94
3460427-46042786.36286.45
4494116-49411692.68192.78
5476425-47642589.36389.46
6483556-48355690.70090.81
15min1527053-52705398.85999.981.4999.09100.221.49
2536015-536015100.540100.79
3537695-537695100.855101.09
4545146-545146102.252102.51
5527418-52741898.92799.17
6524737-52473798.42498.68
20min1542872-542872101.826102.431.91102.23102.851.90
2548302-548302102.844103.26
3553281-553281103.778104.18
4559979-559979105.035105.46
5542552-542552101.766102.18
6529673-52967399.35099.77
30min1545191-545191102.261102.741.99102.83103.331.98
2548801-548801102.938103.53
3555566-555566104.207104.78
4562022-562022105.418106.02
5544877-544877102.202102.78
6530165-53016599.442100.03
45min1544178-544178102.071102.622.04102.81103.382.03
2548158-548158102.817103.58
3555087-555087104.117104.87
4561482-561482105.317106.10
5544859-544859102.199102.95
6528800-52880099.18699.94
60min1542522-542522101.760102.381.96102.67103.311.96
2546701-546701102.544103.48
3553417-553417103.804104.73
4560123-560123105.062106.02
5543542-543542101.952102.87
6528734-52873499.174100.09
极限1541870-541870101.638102.131.96102.72103.231.95
2545429-545429102.306103.41
3552023-552023103.542104.64
4558568-558568104.770105.90
5541717-541717101.609102.70
6527316-52731698.90899.99
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%
116.031541341543051541401541041540921541550.06
216.111534251533741534000.03
单位质量响应值RSD%判断
9616.669522.040.70数据可信
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%
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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