瑞舒伐他汀钙依折麦布片项目信息
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RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.414908904894974897054897464891874898050.14
211.364907204903234905220.06
单位质量响应值RSD%判断
42927.7043179.750.42数据可信
中间条件18月-供试品溶液-CLB05410批-瑞舒伐他汀钙-pH7.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1410853-41085381.54478.085.6481.5478.085.63
2394124-39412478.22378.22
3426394-42639484.62884.63
4380450-38045075.50975.51
5383362-38336276.08776.09
6365284-36528472.49972.50
10min1469041-46904193.09292.253.5793.2392.383.57
2479226-47922695.11495.24
3464246-46424692.14192.28
4457688-45768890.83990.96
5482093-48209395.68395.81
6436582-43658286.65086.77
15min1477186-47718694.70995.362.2695.0095.642.26
2489750-48975097.20397.49
3471815-47181593.64393.94
4485964-48596496.45196.73
5492779-49277997.80498.09
6465172-46517292.32492.59
20min1477720-47772094.81595.412.2395.2695.852.23
2489540-48954097.16197.61
3472188-47218893.71794.17
4487020-48702096.66197.10
5492502-49250297.74998.20
6465345-46534592.35992.78
30min1475563-47556394.38795.442.1894.9996.042.17
2488390-48839096.93397.55
3472821-47282193.84394.45
4487639-48763996.78497.38
5493652-49365297.97798.59
6467220-46722092.73193.30
45min1475840-47584094.44295.222.2095.2195.982.19
2487029-48702996.66297.44
3473680-47368094.01394.78
4486880-48688096.63397.39
5491465-49146597.54398.32
6463639-46363992.02092.75
60min1475088-47508894.29295.012.1995.2195.932.19
2486477-48647796.55397.49
3471458-47145893.57294.49
4485365-48536596.33297.25
5490538-49053897.35998.30
6463363-46336391.96592.85
极限1473663-47366394.01094.822.0995.0995.902.09
2486781-48678196.61397.71
3471049-47104993.49194.57
4483779-48377996.01797.10
5488027-48802796.86197.96
6463202-46320291.93392.97
瑞舒伐他汀钙依折麦布片项目信息
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.144433374426964427644435384426544429980.10
211.214422644421574422100.02
单位质量响应值RSD%判断
39766.4339447.810.57数据可信
中间条件18月-供试品溶液-CLB05410批-依折麦布-pH7.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1193613-19361343.88636.5626.6743.8936.5626.67
2184141-18414141.73941.74
3157383-15738335.67435.67
4113921-11392125.82225.82
5211449-21144947.92947.93
6107368-10736824.33724.34
10min1382028-38202886.59378.8712.2186.6778.9312.23
2381695-38169586.51886.59
3335528-33552876.05376.11
4306036-30603669.36869.41
5389770-38977088.34888.43
6292597-29259766.32266.36
15min1432791-43279198.10097.501.8898.3297.701.91
2434919-43491998.58298.80
3426669-42666996.71296.90
4424624-42462496.24896.41
5442223-442223100.238100.46
6419729-41972995.13995.29
20min1433546-43354698.27198.770.7198.6599.120.72
2435352-43535298.68099.06
3432726-43272698.08598.43
4436449-43644998.92999.25
5441373-441373100.045100.44
6434988-43498898.59898.91
30min1432043-43204397.93098.760.7598.4799.280.75
2434882-43488298.57499.12
3433546-43354698.27198.78
4437960-43796099.27199.76
5441007-44100799.962100.52
6434801-43480198.55599.03
45min1432605-43260598.05798.680.7498.7799.360.75
2436069-43606998.84399.55
3431923-43192397.90398.58
4437970-43797099.27499.92
5439942-43994299.721100.45
6433481-43348198.25698.89
60min1431617-43161797.83498.460.7298.7099.300.73
2433135-43313598.17899.05
3431706-43170697.85498.69
4436991-43699199.05299.87
5439332-43933299.582100.48
6433410-43341098.24099.04
极限1430219-43021997.51798.160.6498.5599.170.64
2432403-43240398.01299.05
3431035-43103597.70298.70
4434999-43499998.60099.58
5437534-43753499.175100.23
6432133-43213397.95098.92
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