依折麦布阿托伐他汀片项目信息
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对照品来源工作对照品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%
110.221728001732001734991737521734361733370.21
210.161701781703621702700.08
单位质量响应值RSD%判断
16960.5716758.860.85数据可信
供试品溶液-2023121621批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min152302-5230227.82926.0619.9727.8326.0619.96
236377-3637719.35519.36
365143-6514334.66134.66
450286-5028626.75626.76
547330-4733025.18325.18
642453-4245322.58822.59
10min1134920-13492071.78768.107.4371.9468.257.46
2122129-12212964.98265.09
3142732-14273275.94476.14
4125216-12521666.62466.77
5126962-12696267.55367.69
6116016-11601661.72961.85
15min1162573-16257386.50183.933.0687.0584.463.08
2157983-15798384.05984.53
3160197-16019785.23785.85
4158042-15804284.09084.61
5159160-15916084.68585.20
6148528-14852879.02879.50
20min1170386-17038690.65889.561.5591.6990.551.57
2167709-16770989.23490.17
3168241-16824189.51790.60
4166671-16667188.68189.67
5172100-17210091.57092.56
6164856-16485687.71688.62
30min1177968-17796894.69293.510.8696.2394.990.86
2176638-17663893.98595.42
3173977-17397792.56994.15
4175972-17597293.63095.11
5175687-17568793.47994.97
6174190-17419092.68294.08
45min1177629-17762994.51294.331.7396.5896.341.67
2173051-17305192.07694.03
3175211-17521193.22595.32
4180298-18029895.93297.93
5176409-17640993.86395.88
6181122-18112296.37098.28
60min1174186-17418692.68094.751.5595.2797.281.47
2178153-17815394.79197.26
3175426-17542693.34095.96
4181220-18122096.42398.95
5180038-18003895.79498.33
6179477-17947795.49597.94
极限1175149-17514993.19293.441.4396.3096.501.33
2179291-17929195.39698.39
3173419-17341992.27295.41
4175203-17520393.22196.29
5172791-17279191.93895.01
6177805-17780594.60597.58
依折麦布阿托伐他汀片项目信息
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2500
标示量(mg)20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%
111.143123973135373138343141353138703135550.22
211.073070163078103074130.19
单位质量响应值RSD%判断
28146.7727769.920.96数据可信
供试品溶液-2023121621批-阿托伐他汀-pH6.8(内含0.2%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1244570-24457072.25962.2626.8072.2662.2626.80
2238129-23812970.35670.36
3264079-26407978.02378.02
4239380-23938070.72670.73
5131924-13192438.97738.98
6146179-14617943.18943.19
10min1297676-29767687.94988.274.0188.3588.624.09
2303315-30331589.61590.01
3312817-31281792.42392.86
4308879-30887991.25991.65
5282422-28242283.44283.66
6287463-28746384.93285.17
15min1309978-30997891.58491.752.3592.4792.592.40
2319461-31946194.38695.27
3310688-31068891.79492.74
4316432-31643293.49194.39
5308181-30818191.05391.73
6298540-29854088.20588.92
20min1310833-31083391.83792.841.6293.2494.191.61
2318779-31877994.18495.60
3312861-31286192.43693.89
4315083-31508393.09294.51
5320804-32080494.78395.97
6307054-30705490.72091.92
30min1315631-31563193.25493.731.5895.1695.591.61
2323901-32390195.69897.63
3314274-31427492.85394.82
4321379-32137994.95296.89
5318084-31808493.97995.69
6310115-31011591.62493.33
45min1312621-31262192.36593.621.5794.7996.011.51
2314604-31460492.95195.42
3312748-31274892.40294.89
4325614-32561496.20498.67
5316499-31649993.51195.75
6319211-31921194.31296.53
60min1305776-30577690.34293.922.4693.2896.822.39
2322521-32252195.29098.27
3312892-31289292.44595.44
4327214-32721496.67699.67
5322631-32263195.32298.08
6316265-31626593.44196.18
极限1308290-30829091.08592.662.0394.5396.092.01
2325048-32504896.03699.55
3309301-30930191.38494.90
4316415-31641593.48697.02
5309612-30961291.47694.76
6313081-31308192.50195.76
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