依折麦布瑞舒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RSF-7013-230318D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5000
标示量(mg)10供试品稀释倍数5系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.561723101721391722271722661723111722510.05
211.521729501744991737240.64
单位质量响应值RSD%判断
14900.6115080.210.85数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH2.0(内含0.1%吐温80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192546-9254652.86655.8312.0252.8755.8312.01
2102129-10212958.34058.34
3101255-10125557.84157.84
4111969-11196963.96163.96
5101180-10118057.79857.80
677338-7733844.17844.18
10min1140309-14030980.15082.292.2380.4482.602.24
2147772-14777284.41384.74
3147575-14757584.30084.62
4144545-14454582.56982.92
5140822-14082280.44380.76
6143344-14334481.88382.13
15min1161480-16148092.24390.842.2792.9891.612.22
2158879-15887990.75891.55
3160246-16024691.53892.33
4152450-15245087.08587.90
5158352-15835290.45691.22
6162748-16274892.96893.67
20min1162959-16295993.08894.143.4894.3495.413.41
2166550-16655095.13996.44
3167522-16752295.69596.99
4156332-15633289.30390.60
5162195-16219592.65293.92
6173269-17326998.978100.19
30min1167335-16733595.58895.674.2697.3697.474.18
2172934-17293498.786100.61
3168575-16857596.29698.13
4157366-15736689.89391.69
5161810-16181092.43294.22
6176895-176895101.049102.82
45min1169958-16995897.08695.593.7399.3997.923.65
2170169-17016997.20799.58
3166126-16612694.89797.26
4156188-15618889.22091.51
5167019-16701995.40797.71
6174622-17462299.750102.08
60min1160872-16087291.89694.512.7694.7397.372.71
2167690-16769095.79198.71
3166645-16664595.19498.09
4160262-16026291.54894.34
5164821-16482194.15296.98
6172444-17244498.506101.39
极限1165361-16536194.46092.122.7497.8195.502.68
2164648-16464894.05397.50
3158502-15850290.54293.96
4154135-15413588.04891.35
5160473-16047391.66895.02
6164466-16446693.94997.38
依折麦布瑞舒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RSF-7013-230318D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5000
标示量(mg)10供试品稀释倍数5系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.561733491727091735491743501730721734060.36
211.521747661750051748860.10
单位质量响应值RSD%判断
15000.5215181.080.85数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH4.5(内含0.1%吐温80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1146387-14638783.06578.107.6983.0778.107.69
2146084-14608482.89382.89
3147011-14701183.41983.42
4134779-13477976.47976.48
5121680-12168069.04669.05
6129842-12984273.67773.68
10min1171890-17189097.53793.452.8698.0093.882.88
2168222-16822295.45595.92
3165583-16558393.95894.42
4160666-16066691.16891.59
5160517-16051791.08391.47
6161233-16123391.48991.90
15min1173461-17346198.42896.231.5999.4397.181.60
2170456-17045696.72397.71
3169072-16907295.93896.92
4168438-16843895.57896.51
5170729-17072996.87897.77
6165393-16539393.85094.77
20min1172932-17293298.12897.541.3299.6899.031.33
2171095-17109597.08698.61
3175363-17536399.507101.03
4168470-16847095.59697.06
5172061-17206197.63499.06
6171504-17150497.31898.76
30min1168293-16829395.49695.521.9697.5997.561.90
2163075-16307592.53594.60
3170797-17079796.91698.99
4166883-16688394.69596.69
5172599-17259997.93999.91
6168423-16842395.56997.55
45min1166600-16660094.53595.672.8097.1698.232.73
2164617-16461793.41095.99
3173619-17361998.518101.13
4164308-16430893.23495.75
5175357-17535799.504102.02
6167110-16711094.82497.33
60min1168828-16882895.79995.931.5698.9599.021.51
2164075-16407593.10296.20
3170964-17096497.011100.17
4168918-16891895.85098.89
5170895-17089596.972100.04
6170626-17062696.81999.86
极限1164295-16429593.22794.532.5296.9198.162.46
2165853-16585394.11197.73
3171870-17187097.525101.22
4160834-16083491.26394.83
5171094-17109497.085100.69
6165609-16560993.97397.55
依折麦布瑞舒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RSF-7013-230318D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5000
标示量(mg)10供试品稀释倍数5系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.561718731719371746991727531728721728270.67
211.521749441750181749810.03
单位质量响应值RSD%判断
14950.4315189.321.13数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH6.6(内含0.1%吐温80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1162531-16253192.35783.5816.4392.3683.5816.43
2158715-15871590.18890.19
3144228-14422881.95681.96
4167962-16796295.44395.44
5101254-10125457.53757.54
6147806-14780683.98983.99
10min1169807-16980796.49194.956.0697.0095.416.10
2169650-16965096.40296.90
3171545-17154597.47997.93
4174458-17445899.13499.66
5146767-14676783.39983.72
6170359-17035996.80597.27
15min1166056-16605694.36097.882.9095.4198.872.91
2170118-17011896.66897.70
3178698-178698101.543102.54
4175887-17588799.946101.03
5167817-16781795.36096.14
6174890-17489099.379100.38
20min1170043-17004396.62597.330.8798.2098.870.77
2172219-17221997.86299.44
3171240-17124097.30598.87
4170499-17049996.88498.52
5173772-17377298.744100.06
6169924-16992496.55898.11
30min1162380-16238092.27195.932.0094.3898.001.94
2171269-17126997.32299.44
3170733-17073397.01799.12
4168105-16810595.52497.70
5169453-16945396.29098.15
6170930-17093097.12999.22
45min1161942-16194292.02296.312.4494.6498.912.38
2173352-17335298.505101.16
3170780-17078097.04499.68
4172141-17214197.817100.52
5170841-17084197.07999.47
6167850-16785095.37998.01
60min1165908-16590894.27594.861.2097.4198.001.13
2165076-16507693.80397.01
3168279-16827995.62398.80
4164828-16482893.66296.91
5167608-16760895.24198.18
6169906-16990696.54799.71
极限1161530-16153091.78894.592.7495.4598.262.65
2161748-16174891.91295.64
3171491-17149197.448101.16
4171669-17166997.549101.32
5167699-16769995.29398.76
6164652-16465293.56297.26
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