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%
110.221678221682421694341696621697911689900.54
210.161675701693701684700.76
单位质量响应值RSD%判断
16535.2316581.690.20数据可信
供试品溶液-2023120823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%
5min163218-6321834.24730.5521.6134.2530.5521.61
238762-3876220.99921.00
353407-5340728.93328.93
475047-7504740.65640.66
556762-5676230.75030.75
651127-5112727.69727.70
10min1131439-13143971.20573.115.2171.4073.285.21
2136382-13638273.88374.00
3140184-14018475.94376.10
4141844-14184476.84277.07
5122607-12260766.42166.59
6137254-13725474.35574.51
15min1154545-15454583.72386.963.1584.3187.543.15
2163166-16316688.39388.92
3160899-16089987.16587.75
4164802-16480289.27989.93
5154120-15412083.49284.03
6165586-16558689.70490.27
20min1167240-16724090.60091.881.0791.6592.941.08
2171397-17139792.85293.87
3170459-17045992.34493.41
4171551-17155192.93594.08
5167978-16797891.00092.00
6169045-16904591.57892.64
30min1173000-17300093.72094.991.4795.2796.561.42
2180224-18022497.63499.17
3174158-17415894.34895.93
4173944-17394494.23295.90
5175722-17572295.19596.70
6174965-17496594.78596.36
45min1177863-17786396.35596.531.7498.4398.621.69
2182520-18252098.878100.95
3176987-17698795.88097.98
4178450-17845096.67398.86
5179988-17998897.50699.54
6173298-17329893.88295.98
60min1178787-17878796.85596.531.0299.4799.170.99
2180448-18044897.755100.38
3177641-17764196.23598.87
4178356-17835696.62299.35
5178916-17891696.92599.51
6175019-17501994.81497.44
极限1175245-17524594.93795.071.3698.0898.241.34
2177447-17744796.12999.30
3171434-17143492.87296.04
4178073-17807396.46999.73
5176185-17618595.44698.56
6174562-17456294.56797.72
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%
111.141545191554521557521560371564991556520.48
211.071553601566251559920.58
单位质量响应值RSD%判断
13972.3514091.420.61数据可信
供试品溶液-2023120823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%
5min1133918-13391878.83476.9210.1278.8376.9210.12
2115495-11549567.98867.99
3135239-13523979.61179.61
4149474-14947487.99187.99
5115134-11513467.77667.78
6134738-13473879.31679.32
10min1156872-15687292.34692.751.2592.7893.181.28
2155441-15544191.50391.88
3157892-15789292.94693.39
4160228-16022894.32194.81
5155616-15561691.60691.98
6159328-15932893.79294.23
15min1156713-15671392.25294.391.8893.2095.331.88
2158737-15873793.44494.33
3158790-15879093.47594.43
4162269-16226995.52396.54
5160332-16033294.38395.27
6165186-16518697.24098.20
20min1157536-15753692.73794.091.1394.2095.561.13
2158566-15856693.34394.75
3159054-15905493.63095.11
4160480-16048094.47096.01
5160873-16087394.70196.11
6162495-16249595.65697.16
30min1156041-15604191.85793.661.2593.8495.651.22
2160020-16002094.19996.12
3160587-16058794.53396.53
4157444-15744492.68394.75
5159334-15933493.79595.73
6161218-16121894.90496.94
45min1157604-15760492.77793.810.9795.2796.320.96
2159104-15910493.66096.11
3157984-15798493.00095.52
4161655-16165595.16197.74
5160573-16057394.52596.98
6159277-15927793.76296.32
60min1157794-15779492.88993.610.6495.8996.640.66
2158036-15803693.03196.00
3158680-15868093.41096.45
4159916-15991694.13897.25
5159478-15947893.88096.86
6160229-16022994.32297.40
极限1154483-15448390.94092.161.7594.4695.711.72
2155601-15560191.59895.08
3152861-15286189.98593.54
4159642-15964293.97697.61
5157261-15726192.57596.08
6159474-15947493.87897.48
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