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%
110.021724481714501715061716051716821717380.24
210.031697301701671699480.19
单位质量响应值RSD%判断
17139.5216943.970.82数据可信
供试品溶液-2024011221批-依折麦布-pH6.8(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%
5min161795-6179532.52831.7515.1732.5331.7515.17
274094-7409439.00239.00
353654-5365428.24328.24
449147-4914725.87025.87
566797-6679735.16135.16
656430-5643029.70429.70
10min1136653-13665371.93377.746.1772.1177.916.17
2151363-15136379.67679.89
3149000-14900078.43278.59
4136453-13645371.82771.97
5154995-15499581.58881.78
6157595-15759582.95683.12
15min1172158-17215890.62292.452.0091.2093.052.02
2175980-17598092.63493.29
3176082-17608292.68893.28
4171183-17118390.10990.65
5177767-17776793.57594.22
6180586-18058695.05995.68
20min1181776-18177695.68596.311.1096.7797.431.07
2181763-18176395.67896.85
3185744-18574497.77498.88
4183532-18353296.60997.65
5180409-18040994.96596.13
6184559-18455997.15098.30
30min1188937-18893799.45498.840.81101.07100.500.75
2186920-18692098.393100.10
3188898-18889899.434101.08
4189492-18949299.747101.33
5185876-18587697.84399.54
6186547-18654798.19699.89
45min1191130-191130100.60999.661.67102.78101.871.60
2184751-18475197.25199.50
3190747-190747100.407102.61
4192961-192961101.573103.71
5186242-18624298.036100.28
6190189-190189100.113102.35
60min1190631-190631100.34699.191.29103.07101.951.23
2186685-18668598.269101.06
3189836-18983699.928102.69
4190469-190469100.261102.96
5184538-18453897.13999.92
6188487-18848799.218102.01
极限1185614-18561497.70597.260.58100.99100.570.55
2185320-18532097.551100.89
3183776-18377696.738100.05
4184937-18493797.349100.60
5185788-18578897.797101.12
6183162-18316296.41599.76
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%
111.171600591610281610341610981610611608560.28
211.111593431595821594620.11
单位质量响应值RSD%判断
14400.7214353.020.24数据可信
供试品溶液-2024011221批-阿托伐他汀钙-pH6.8(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%
5min1101533-10153358.33465.3326.8858.3365.3426.88
266988-6698838.48738.49
3104481-10448160.02860.03
4118861-11886168.29068.29
5156234-15623489.76289.76
6134204-13420477.10577.11
10min1168546-16854696.83694.005.6697.1694.365.73
2149442-14944285.86086.07
3156572-15657289.95690.29
4163997-16399794.22294.60
5175194-175194100.655101.15
6167943-16794396.48996.92
15min1183241-183241105.279100.143.52106.14101.023.56
2165892-16589295.31196.00
3169275-16927597.25598.09
4174350-174350100.170101.07
5177443-177443101.947103.01
6175548-175548100.859101.82
20min1179937-179937103.380100.092.38104.83101.532.42
2167616-16761696.30197.52
3173121-17312199.464100.84
4176940-176940101.658103.12
5173573-17357399.724101.35
6174081-174081100.016101.54
30min1179908-179908103.36499.962.18105.38101.962.22
2168843-16884397.00698.76
3172222-17222298.948100.87
4175886-175886101.053103.08
5174730-174730100.389102.57
6172355-17235599.024101.10
45min1179775-179775103.287100.122.66105.88102.682.70
2166067-16606795.41197.71
3173613-17361399.747102.22
4177064-177064101.730104.32
5173904-17390499.914102.65
6175179-175179100.647103.28
60min1179040-179040102.86599.562.12106.03102.672.16
2167729-16772996.36699.19
3172466-17246699.088102.12
4174254-174254100.115103.27
5172301-17230198.993102.28
6173928-17392899.928103.12
极限1174203-174203100.08697.062.02103.83100.722.07
2165618-16561895.15398.51
3165411-16541195.03598.62
4167639-16763996.315100.02
5170953-17095398.219102.06
6169809-16980997.561101.31
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