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%
110.021694681686431677001683921677911683990.43
210.031682211680991681600.06
单位质量响应值RSD%判断
16806.2916765.700.18数据可信
供试品溶液-2024011221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%
5min146665-4666524.93729.7240.3524.9429.7240.34
246752-4675224.98424.98
358402-5840231.21031.21
499386-9938653.11153.11
537931-3793120.27020.27
644571-4457123.81823.82
10min1161580-16158086.34779.789.7686.4979.959.79
2140471-14047175.06775.21
3138221-13822173.86474.04
4169383-16938390.51790.81
5132381-13238170.74370.86
6153732-15373282.15382.29
15min1177769-17776994.99892.833.4095.6293.443.46
2169732-16973290.70491.26
3169694-16969490.68391.27
4181201-18120196.83297.63
5166336-16633688.88989.39
6177538-17753894.87595.46
20min1179945-17994596.16195.202.1697.3196.332.18
2175152-17515293.60094.66
3178200-17820095.22996.32
4177815-17781595.02396.36
5173414-17341492.67193.67
6184407-18440798.54699.66
30min1175781-17578193.93694.601.3195.6296.261.28
2178258-17825895.26096.84
3177765-17776594.99696.61
4175096-17509693.57095.43
5174594-17459493.30294.82
6180676-18067696.55298.22
45min1168221-16822189.89691.561.3992.1093.741.28
2172854-17285492.37294.48
3171711-17171191.76193.91
4168550-16855090.07292.46
5172871-17287192.38194.41
6173787-17378792.87195.07
60min1163640-16364087.44888.961.1390.1591.651.09
2165099-16509988.22890.85
3166252-16625288.84491.50
4167261-16726189.38392.27
5168657-16865790.12992.67
6167904-16790489.72792.44
极限1161658-16165886.38988.001.3789.5891.181.29
2164260-16426087.77990.89
3163508-16350887.37790.53
4163948-16394887.61390.99
5167239-16723989.37192.42
6167403-16740389.45992.67
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%
111.171593901598031591491590461592221593220.19
211.111591541590091590820.07
单位质量响应值RSD%判断
14263.3814318.810.28数据可信
供试品溶液-2024011221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%
5min195005-9500554.91154.9924.3154.9154.9924.31
294809-9480954.79854.80
356684-5668432.76232.76
4128973-12897374.54474.54
5102004-10200458.95758.96
693401-9340153.98453.98
10min1168821-16882197.57689.009.2997.8889.319.31
2133075-13307576.91577.22
3139868-13986880.84281.02
4162033-16203393.65394.07
5163770-16377094.65794.98
6156351-15635190.36890.67
15min1171982-17198299.40395.534.16100.2596.334.21
2154516-15451689.30890.04
3159742-15974292.32892.96
4168968-16896897.66198.60
5170813-17081398.72799.58
6165682-16568295.76296.56
20min1172537-17253799.72496.512.41101.1297.842.45
2161763-16176393.49694.72
3164440-16444095.04496.19
4165775-16577595.81597.29
5170772-17077298.704100.11
6166571-16657196.27597.61
30min1174296-174296100.74098.701.75102.69100.561.76
2172175-17217599.514101.26
3167987-16798797.09498.77
4168332-16833297.29399.30
5173727-173727100.412102.36
6168028-16802897.11898.99
45min1170389-17038998.48298.181.55101.00100.601.55
2172148-17214899.499101.80
3168052-16805297.13199.34
4168839-16883997.586100.14
5173414-173414100.231102.74
6166373-16637396.16198.57
60min1170238-17023898.39598.011.75101.46100.971.78
2170504-17050498.549101.40
3166802-16680296.40999.16
4170209-17020998.378101.47
5173975-173975100.555103.62
6165682-16568295.76298.70
极限1174439-174439100.82399.571.53104.43103.081.53
2174604-174604100.918104.32
3168756-16875697.538100.83
4169526-16952697.983101.62
5174339-174339100.765104.39
6171976-17197699.399102.87
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