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%
110.221684991682211671311669321669191675400.46
210.161696661700801698730.18
单位质量响应值RSD%判断
16393.3516719.781.40数据可信
供试品溶液-2023120821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%
5min135511-3551119.24227.3839.7919.2427.3839.79
247419-4741925.69425.69
384684-8468445.88645.89
451250-5125027.77027.77
526699-2669914.46714.47
657570-5757031.19431.19
10min1106667-10666757.79768.6415.4857.9068.8015.53
2128664-12866469.71769.86
3149891-14989181.21881.47
4137018-13701874.24374.40
599555-9955553.94454.02
6138318-13831874.94875.12
15min1144024-14402478.03986.216.1378.4786.746.21
2160838-16083887.15087.68
3167937-16793790.99791.70
4164077-16407788.90589.47
5150458-15045881.52681.91
6167236-16723690.61791.21
20min1162577-16257788.09292.233.1088.9593.243.16
2174761-17476194.69495.71
3169487-16948791.83793.05
4170735-17073592.51393.57
5166701-16670190.32791.16
6177017-17701795.91797.01
30min1171112-17111292.71795.191.5294.0796.721.57
2175234-17523494.95196.49
3175364-17536495.02196.74
4176349-17634995.55597.13
5176813-17681395.80697.14
6179191-17919197.09598.72
45min1176975-17697595.89495.111.3497.7697.161.26
2177236-17723696.03598.10
3171371-17137192.85795.11
4176821-17682195.81097.92
5174093-17409394.33296.20
6176633-17663395.70997.87
60min1175888-17588895.30595.301.7597.7097.881.61
2175278-17527894.97497.58
3172048-17204893.22495.99
4173403-17340393.95896.60
5180403-18040397.751100.14
6178240-17824096.57999.28
极限1174943-17494394.79395.220.9097.7298.330.82
2174551-17455194.58097.71
3173794-17379494.17097.45
4176617-17661795.70098.86
5178067-17806796.48699.42
6176421-17642195.59498.83
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%
111.141551021548791555111551231550521551330.15
211.071561181567161564170.28
单位质量响应值RSD%判断
13925.7614129.811.03数据可信
供试品溶液-2023120821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%
5min1124642-12464273.39774.3111.6073.4074.3111.60
2127980-12798075.36375.36
3147957-14795787.12687.13
4107641-10764163.38663.39
5113495-11349566.83366.83
6135465-13546579.77079.77
10min1156780-15678092.32292.293.1792.7392.703.19
2156953-15695392.42492.84
3162619-16261995.76096.24
4147655-14765586.94887.30
5159121-15912193.70094.07
6157260-15726092.60593.05
15min1161242-16124294.94994.883.1595.8795.813.15
2161170-16117094.90795.84
3164859-16485997.07998.10
4152213-15221389.63390.47
5166957-16695798.31599.21
6160290-16029094.38995.35
20min1163109-16310996.04995.243.3997.5096.693.39
2164319-16431996.76198.22
3161234-16123494.94596.50
4151091-15109188.97290.30
5166332-16633297.94799.38
6164291-16429196.74598.23
30min1158064-15806493.07894.402.9695.0696.382.95
2158283-15828393.20795.20
3162201-16220195.51497.60
4153863-15386390.60492.43
5167795-16779598.808100.79
6161632-16163295.17997.20
45min1162469-16246995.67293.742.0598.1796.252.06
2157773-15777392.90795.42
3159287-15928793.79896.41
4153775-15377590.55292.88
5162452-16245295.66298.19
6159413-15941393.87296.42
60min1158193-15819393.15493.603.4396.1896.623.39
2154984-15498491.26494.30
3158386-15838693.26896.40
4152498-15249889.80092.63
5168061-16806198.965102.03
6161561-16156195.13798.21
极限1157329-15732992.64593.732.0996.1997.282.06
2154437-15443790.94294.48
3159916-15991694.16997.82
4158309-15830993.22296.55
5164184-16418496.682100.29
6160868-16086894.72998.33
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