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%
110.021684861690161694761699481701361694120.40
210.031683991688691686340.20
单位质量响应值RSD%判断
16907.3916812.960.40数据可信
供试品溶液-2024011222批-依折麦布-pH2.0(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%
5min140910-4091021.76638.5636.5221.7738.5636.52
246758-4675824.87724.88
3109051-10905158.02058.02
494452-9445250.25350.25
568439-6843936.41336.41
675244-7524440.03340.03
10min1136742-13674272.75378.487.6972.8778.707.76
2133595-13359571.07971.22
3163214-16321486.83787.16
4156598-15659883.31783.60
5146177-14617777.77377.98
6148701-14870179.11679.34
15min1172248-17224891.64491.172.1992.1791.822.27
2164958-16495887.76588.30
3176489-17648993.90094.70
4172285-17228591.66392.41
5170299-17029990.60791.24
6171827-17182791.42092.08
20min1178450-17845094.94394.690.9395.9895.840.99
2174657-17465792.92593.95
3178456-17845694.94796.27
4178597-17859795.02296.27
5178441-17844194.93996.08
6179221-17922195.35496.52
30min1178088-17808894.75194.080.6696.3195.760.58
2176848-17684894.09195.63
3176460-17646093.88595.74
4174734-17473492.96694.75
5177363-17736394.36596.03
6177452-17745294.41296.11
45min1181040-18104096.32191.314.9898.4193.524.79
2169389-16938990.12392.18
3165696-16569688.15890.53
4158840-15884084.51086.81
5179209-17920995.34797.54
6175536-17553693.39395.62
60min1180445-18044596.00595.330.8498.6398.040.85
2176695-17669594.01096.57
3178882-17888295.17398.04
4178592-17859295.01997.78
5180843-18084396.21798.94
6179595-17959595.55398.30
极限1185477-18547798.68296.251.97101.8499.501.91
2177300-17730094.33297.41
3180824-18082496.20699.60
4178187-17818794.80398.10
5184996-18499698.426101.68
6178697-17869795.07598.35
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%
111.171553941556111559961564061565061559830.32
211.111552151554811553480.13
单位质量响应值RSD%判断
13964.4613982.720.10数据可信
供试品溶液-2024011222批-阿托伐他汀钙-pH2.0(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%
5min1110585-11058565.36977.399.1965.3777.409.19
2124722-12472273.72573.73
3135975-13597580.37780.38
4145038-14503885.73485.73
5131547-13154777.75977.76
6137713-13771381.40481.40
10min1150435-15043588.92493.523.0789.2993.953.10
2157453-15745393.07393.48
3157902-15790293.33893.78
4163939-16393996.90797.38
5156672-15667292.61193.04
6162856-16285696.26796.72
15min1162853-16285396.26598.672.3297.1299.622.33
2165538-16553897.85298.78
3165501-16550197.83098.80
4166550-16655098.45099.46
5166866-16686698.63799.58
6174273-174273103.015104.00
20min1167309-16730998.89999.631.23100.29101.121.25
2167920-16792099.260100.73
3165796-16579698.00599.51
4170353-170353100.698102.26
5168417-16841799.554101.05
6171446-171446101.344102.90
30min1156898-15689892.74596.031.8994.6998.081.90
2163621-16362196.71998.74
3161252-16125295.31997.37
4163005-16300596.35598.48
5164950-16495097.50599.55
6165022-16502297.54799.67
45min1167602-16760299.07293.004.92101.5395.584.75
2149819-14981988.56091.12
3152995-15299590.43893.02
4149128-14912888.15290.81
5163563-16356396.68599.27
6160851-16085195.08297.75
60min1157239-15723992.94695.271.7995.9598.371.81
2159246-15924694.13397.18
3159976-15997694.56497.65
4162630-16263096.13399.28
5162684-16268496.16599.29
6165242-16524297.677100.87
极限1161441-16144195.43096.621.4998.95100.251.47
2161740-16174095.60799.18
3163860-16386096.860100.47
4161856-16185695.67699.36
5167880-16788099.236102.90
6163901-16390196.884100.62
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