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(%)99.70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%
1 12.114768164755314743894753174752394754580.19
2 12.114729544740064734800.16
单位质量响应值RSD%判断
39261.6039098.270.30数据可信
供试品溶液-2批-氢氯噻嗪-含0.35%吐温20的磷酸盐缓冲液(pH6.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1278071-27807150.94746.8711.3950.9546.8711.39
2236317-23631743.29743.30
3265727-26572748.68648.69
4293652-29365253.80253.80
5213870-21387039.18539.18
6247128-24712845.27845.28
10min1410976-41097675.29869.718.9675.3869.788.96
2353318-35331864.73464.81
3384409-38440970.43070.51
4419455-41945576.85176.94
5329645-32964560.39760.46
6384981-38498170.53570.61
15min1459087-45908784.11378.636.9184.3278.826.91
2412777-41277775.62875.81
3441537-44153780.89781.10
4457305-45730583.78684.00
5381962-38196269.98270.15
6422231-42223177.36077.55
20min1482090-48209088.32783.366.2288.6883.696.23
2443752-44375281.30381.61
3474651-47465186.96487.30
4479659-47965987.88288.24
5412043-41204375.49375.78
6437732-43773280.20080.52
30min1505477-50547792.61288.135.3193.1188.605.32
2474739-47473986.98087.42
3497078-49707891.07391.55
4504957-50495792.51793.02
5444778-44477881.49181.90
6459208-45920884.13584.59
45min1529048-52904896.93193.424.4397.5894.034.45
2511290-51129093.67794.26
3520087-52008795.28995.92
4533690-53369097.78198.44
5479940-47994087.93388.48
6485114-48511488.88189.48
60min1539891-53989198.91797.073.7399.7397.833.75
2537195-53719598.42399.17
3536182-53618298.23899.03
4554000-554000101.502102.32
5503750-50375092.29692.99
6507699-50769993.01993.76
极限1563044-563044103.159103.752.73104.14104.682.74
2575295-575295105.404106.31
3566169-566169103.732104.68
4590940-590940108.270109.26
5547316-547316100.278101.12
6554876-554876101.663102.56
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(%)99.80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%
116.043035813029943027273023063046983032610.31
216.083020863019793020320.03
单位质量响应值RSD%判断
18906.5518783.080.47数据可信
供试品溶液-2批-坎地沙坦酯-含0.35%吐温20的磷酸盐缓冲液(pH6.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1104056-10405630.99829.249.5631.0029.249.57
292363-9236327.51527.51
3102942-10294230.66630.67
4110701-11070132.97732.98
584975-8497525.31425.31
693950-9395027.98727.99
10min1209168-20916862.31058.688.0762.3658.728.07
2184244-18424454.88654.93
3195881-19588158.35258.40
4216167-21616764.39564.45
5173587-17358751.71151.75
6202740-20274060.39660.44
15min1264466-26446678.78474.826.3578.9474.976.36
2240662-24066271.69271.83
3253346-25334675.47175.62
4270104-27010480.46380.63
5226287-22628767.41067.54
6252138-25213875.11175.26
20min1290577-29057786.56283.094.9686.8583.364.97
2272535-27253581.18781.44
3283358-28335884.41184.69
4295549-29554988.04388.34
5257522-25752276.71576.96
6273979-27397981.61781.89
30min1315391-31539193.95490.414.7694.3990.824.77
2300559-30055989.53689.93
3312533-31253393.10393.52
4318527-31852794.88895.33
5282533-28253384.16684.53
6291502-29150286.83887.25
45min1325771-32577197.04694.524.1097.6395.084.11
2317833-31783394.68195.22
3323254-32325496.29696.87
4333212-33321299.26399.86
5299846-29984689.32389.83
6303865-30386590.52091.07
60min1326375-32637597.22696.403.4697.9897.123.47
2327027-32702797.42098.12
3326956-32695697.39998.13
4339762-339762101.214101.98
5309764-30976492.27892.94
6311715-31171592.85993.56
极限1328650-32865097.90498.772.7898.8299.652.78
2335055-33505599.812100.67
3329665-32966598.20699.10
4348091-348091103.695104.63
5321901-32190195.89396.70
6325996-32599697.11397.97
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(%)99.70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%
1 12.114715344715304712234714164718814715170.06
2 12.114713814708754711280.08
单位质量响应值RSD%判断
38936.1738904.050.06数据可信
供试品溶液-2024090121批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1220330-22033040.63848.3613.3040.6448.3613.30
2250744-25074446.24746.25
3306287-30628756.49156.49
4272337-27233750.23050.23
5229062-22906242.24842.25
6294572-29457254.33154.33
10min1400080-40008073.79175.915.6873.8675.995.68
2380562-38056270.19170.27
3422046-42204677.84277.94
4432711-43271179.80979.89
5394443-39444372.75172.82
6439611-43961181.08281.17
15min1473008-47300887.24186.864.3587.4387.064.35
2438355-43835580.85081.04
3465575-46557585.87086.09
4493802-49380291.07791.29
5463474-46347485.48385.67
6491456-49145690.64490.87
20min1497166-49716691.69790.903.3092.0391.253.30
2468771-46877186.46086.79
3482343-48234388.96389.33
4512904-51290494.60094.97
5489025-48902590.19590.53
6506807-50680793.47593.85
30min1513777-51377794.76194.352.1695.2594.862.17
2496557-49655791.58592.06
3504956-50495693.13493.65
4525013-52501396.83397.36
5506398-50639893.40093.88
6522695-52269596.40696.94
45min1528516-52851697.47997.301.1898.1397.961.19
2519500-51950095.81696.44
3525502-52550296.92397.59
4534627-53462798.60699.29
5522648-52264896.39797.04
6534416-53441698.56799.26
60min1536044-53604498.86898.770.5599.6899.590.58
2531803-53180398.08598.87
3535354-53535498.74099.57
4538805-53880599.377100.23
5532512-53251298.21699.02
6538584-53858499.336100.19
极限1540737-54073799.73399.780.62100.71100.770.63
2541555-54155599.884100.83
3540916-54091699.766100.76
4540110-54011099.618100.64
5536175-53617598.89299.86
6546577-546577100.810101.83
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(%)99.80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%
116.043021193022903017653016433020033019640.09
216.083021483015843018660.14
单位质量响应值RSD%判断
18825.6918772.760.20数据可信
供试品溶液-2024090121批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183034-8303424.79529.5413.3624.8029.5413.36
293964-9396428.05928.06
3117170-11717034.98934.99
4102798-10279830.69730.70
587166-8716626.02926.03
6109377-10937732.66232.66
10min1187419-18741955.96659.035.7156.0159.085.71
2183858-18385854.90354.95
3208834-20883462.36162.42
4204337-20433761.01861.07
5192170-19217057.38557.43
6209515-20951562.56562.62
15min1251083-25108374.97874.953.3075.1175.103.30
2236286-23628670.55970.70
3253634-25363475.73975.90
4257843-25784376.99677.15
5248105-24810574.08874.23
6258979-25897977.33577.49
20min1281415-28141584.03583.162.7484.2983.432.74
2265106-26510679.16579.42
3276380-27638082.53282.82
4285616-28561685.29085.57
5277183-27718382.77183.03
6285195-28519585.16485.45
30min1303930-30393090.75990.101.6191.1690.521.61
2293852-29385287.74988.14
3299055-29905589.30389.73
4307318-30731891.77092.19
5301085-30108589.90990.31
6305161-30516191.12691.56
45min1312032-31203293.17892.720.8693.7393.280.87
2307592-30759291.85292.39
3308678-30867892.17692.75
4313640-31364093.65894.23
5308149-30814992.01892.57
6312961-31296193.45594.04
60min1312873-31287393.42993.180.5094.1493.900.50
2311430-31143092.99893.69
3310732-31073292.79093.52
4314435-31443593.89694.63
5310236-31023692.64293.35
6312445-31244593.30194.04
极限1315779-31577994.29793.970.6595.1694.840.66
2314638-31463893.95694.80
3313430-31343093.59594.48
4315473-31547394.20595.09
5311449-31144993.00493.86
6317335-31733594.76295.65
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