依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.021721331712571710171709901709241712640.30
210.031723991719941721960.17
单位质量响应值RSD%判断
17092.2217168.100.32数据可信
供试品溶液-2024011223批-依折麦布-shui(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156649-5664929.66535.7420.5129.6635.7420.51
283854-8385443.91143.91
347789-4778925.02525.03
466139-6613934.63434.63
579273-7927341.51241.51
675790-7579039.68839.69
10min1146173-14617376.54583.516.3976.7183.716.41
2162849-16284985.27785.52
3155365-15536581.35881.50
4151611-15161179.39279.58
5172715-17271590.44490.67
6168166-16816688.06188.28
15min1176409-17640992.37894.292.1192.9794.962.15
2178731-17873193.59494.31
3179203-17920393.84194.43
4176621-17662192.48993.12
5185278-18527897.02297.76
6184159-18415996.43697.15
20min1182699-18269995.67297.441.9296.7898.621.93
2186580-18658097.70498.94
3190129-19012999.563100.67
4180860-18086094.70995.86
5187605-18760598.24199.51
6188547-18854798.73499.98
30min1180584-18058494.56494.671.1996.2096.401.20
2182834-18283495.74297.52
3182071-18207195.34397.01
4176769-17676992.56794.24
5181717-18171795.15896.98
6180739-18073994.64596.44
45min1173042-17304290.61590.163.8992.7792.423.78
2179002-17900293.73696.05
3170932-17093289.51091.71
4173476-17347690.84293.03
5159837-15983783.70086.05
6176767-17676792.56594.89
60min1162968-16296885.34087.942.0488.0090.702.03
2173491-17349190.85093.68
3167434-16743487.67890.37
4169218-16921888.61291.30
5167227-16722787.57090.38
6167301-16730187.60990.44
极限1166680-16668087.28387.101.2490.4290.341.22
2168133-16813388.04491.38
3164095-16409585.93089.11
4166709-16670987.29990.48
5168698-16869888.34091.64
6163662-16366285.70389.02
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.171587061580561577871573771575561578960.33
211.111583451584401583920.05
单位质量响应值RSD%判断
14135.7214256.710.61数据可信
供试品溶液-2024011223批-阿托伐他汀钙-shui(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1101167-10116758.86568.1320.5958.8668.1320.59
2138844-13884480.78780.79
377594-7759445.14945.15
4129876-12987675.56975.57
5116624-11662467.85867.86
6138418-13841880.53980.54
10min1159436-15943692.76996.252.5893.1096.622.64
2170032-17003298.93499.38
3161241-16124193.81994.07
4165228-16522896.13996.56
5168090-16809097.80498.18
6168453-16845398.01598.46
15min1166802-16680297.05598.511.7497.9099.421.67
2166728-16672897.01298.01
3173918-173918101.195101.97
4167393-16739397.39998.35
5171578-17157899.834100.75
6169396-16939698.56499.56
20min1172078-172078100.125100.202.46101.51101.662.36
2170100-17010098.974100.51
3179861-179861104.653105.99
4167185-16718597.27898.77
5172690-172690100.481101.96
6171297-17129799.670101.21
30min1207079-207079120.490102.828.61122.43104.848.40
2170946-17094699.466101.55
3175462-175462102.094104.01
4166135-16613596.66798.70
5172198-172198100.194102.23
6168466-16846698.023100.12
45min1170722-17072299.33697.343.62101.9499.933.54
2171601-17160199.847102.49
3168566-16856698.081100.56
4167218-16721897.29799.87
5155380-15538090.40993.00
6170302-17030299.091101.73
60min1164963-16496395.98597.561.5199.14100.681.46
2171726-17172699.920103.11
3169033-16903398.353101.38
4167704-16770497.580100.69
5167340-16734097.368100.46
6165211-16521196.12999.32
极限1172892-172892100.59899.000.86104.29102.680.84
2169651-16965198.712102.46
3170305-17030599.093102.67
4169185-16918598.441102.10
5168835-16883598.238101.87
6170048-17004898.943102.67
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