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100309-201404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2000
标示量(mg)6.25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%
112.012272822272512270452273382271072272050.06
212.012286462286902286680.02
单位质量响应值RSD%判断
18917.9919039.800.46数据可信
稳定性12月-中间条件-供试品溶液-GJ031批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1109361-10936141.36447.4416.6441.3647.4416.64
2109957-10995741.59041.59
3109362-10936241.36441.36
4154504-15450458.43958.44
5120420-12042045.54745.55
6148888-14888856.31556.31
10min1224296-22429684.83792.415.3384.9192.495.33
2248648-24864894.04794.12
3232830-23283088.06488.13
4251015-25101594.94395.04
5250173-25017394.62494.70
6258951-25895197.94498.04
15min1265397-265397100.38299.301.48100.5999.531.46
2264778-264778100.148100.37
3264482-264482100.036100.25
4262160-26216099.15899.41
5255008-25500896.45396.69
6263391-26339199.62499.88
20min1266364-266364100.74899.351.57101.1399.751.56
2264692-264692100.116100.51
3264618-264618100.088100.47
4262153-26215399.15599.58
5254815-25481596.38096.77
6263344-26334499.606100.03
30min1267480-267480101.17099.701.58101.72100.261.57
2265952-265952100.592101.15
3264936-264936100.208100.76
4262894-26289499.436100.02
5255720-25572096.72297.28
6264535-264535100.056100.65
45min1266674-266674100.86599.511.53101.58100.241.52
2265477-265477100.413101.14
3264618-264618100.088100.80
4262091-26209199.13299.88
5255486-25548696.63497.35
6264162-26416299.915100.67
60min1266100-266100100.64899.341.55101.53100.241.54
2265106-265106100.272101.17
3264181-26418199.922100.81
4261685-26168598.97899.90
5254936-25493696.42697.30
6263863-26386399.802100.72
极限1265696-265696100.49599.161.48101.55100.221.47
2264447-264447100.023101.08
3263380-26338099.619100.67
4261259-26125998.81799.90
5254859-25485996.39697.43
6263341-26334199.605100.69
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100309-201404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2000
标示量(mg)6.25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%
112.012260642259872258322259402258232259290.05
212.012295182298852297020.12
单位质量响应值RSD%判断
18811.7419125.901.18数据可信
稳定性12月-中间条件-供试品溶液-GJ031批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1137234-13723451.93746.5913.0451.9446.5913.04
2116193-11619343.97443.97
3115614-11561443.75543.75
4103700-10370039.24639.25
5118551-11855144.86744.87
6147307-14730755.74955.75
10min1247734-24773493.75793.292.2493.8493.372.25
2247016-24701693.48593.56
3245068-24506892.74892.82
4247278-24727893.58493.65
5237398-23739889.84589.92
6254544-25454496.33496.43
15min1259664-25966498.27299.301.3798.5199.531.37
2261134-26113498.82899.06
3267969-267969101.415101.64
4265452-265452100.462100.68
5258627-25862797.87998.10
6261483-26148398.96099.21
20min1259816-25981698.32999.291.3798.7499.691.36
2261160-26116098.83899.23
3268007-268007101.429101.83
4265517-265517100.487100.88
5259119-25911998.06698.45
6260458-26045898.57298.99
30min1259854-25985498.34499.451.3498.91100.021.33
2261795-26179599.07899.64
3268079-268079101.457102.02
4266072-266072100.697101.25
5259493-25949398.20798.76
6261432-26143298.94199.52
45min1260148-26014898.45599.341.3599.19100.071.34
2261251-26125198.87299.60
3267801-267801101.351102.09
4265919-265919100.639101.36
5259048-25904898.03998.75
6260732-26073298.67699.42
60min1259503-25950398.21199.131.3599.11100.031.35
2260606-26060698.62899.52
3267326-267326101.172102.08
4265345-265345100.422101.31
5258542-25854297.84798.73
6260322-26032298.52199.43
极限1259191-25919198.09399.061.3299.15100.121.31
2260470-26047098.57799.63
3266729-266729100.946102.02
4265427-265427100.453101.51
5258610-25861097.87398.91
6260061-26006198.42299.50
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