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%
110.021702041690251687951687291688411691190.37
210.031714191711321712760.12
单位质量响应值RSD%判断
16878.1417076.370.83数据可信
供试品溶液-2024011221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%
5min174755-7475539.50038.2626.1039.5038.2626.10
291271-9127148.22748.23
387917-8791746.45446.45
442129-4212922.26122.26
580296-8029642.42842.43
658116-5811630.70830.71
10min1147412-14741277.89179.448.1178.1179.658.16
2164476-16447686.90787.18
3159014-15901484.02184.28
4130300-13030068.84968.97
5155751-15575182.29782.53
6145072-14507276.65576.83
15min1170146-17014689.90389.943.1190.5690.603.18
2176115-17611593.05793.81
3173974-17397491.92692.65
4160808-16080884.96985.48
5171080-17108090.39791.09
6169190-16919089.39889.99
20min1176113-17611393.05693.451.1194.2194.601.19
2178785-17878594.46895.74
3178077-17807794.09495.33
4173416-17341691.63192.61
5176653-17665393.34294.54
6178085-17808594.09895.19
30min1184292-18429297.37897.421.0799.0599.091.09
2187317-18731798.976100.77
3183225-18322596.81498.57
4183010-18301096.70198.19
5182258-18225896.30398.02
6186124-18612498.34699.96
45min1187192-18719298.91097.631.16101.1299.841.19
2185430-18543097.979100.32
3184888-18488897.69399.99
4181680-18168095.99898.02
5182841-18284196.61198.86
6186568-18656898.581100.74
60min1186316-18631698.44796.771.36101.2199.531.37
2184813-18481397.653100.54
3182711-18271196.54399.38
4182549-18254996.45799.01
5183511-18351196.96599.75
6178970-17897094.56697.28
极限1184493-18449397.48496.922.77100.79100.222.65
2185084-18508497.796101.23
3173597-17359791.72795.10
4184174-18417497.316100.41
5184649-18464997.567100.89
6188567-18856799.637102.87
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%
111.171586791590321592051591431591331590380.14
211.111617791612001614900.26
单位质量响应值RSD%判断
14237.9614535.551.47数据可信
供试品溶液-2024011221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%
5min1131011-13101175.22765.0616.9275.2365.0616.92
298486-9848656.55156.55
3119355-11935568.53468.53
4109612-10961262.93962.94
585803-8580349.26849.27
6135581-13558177.85177.85
10min1162430-16243093.26787.155.5593.6987.525.60
2141966-14196681.51781.83
3151238-15123886.84187.22
4152018-15201887.28987.64
5143023-14302382.12482.40
6160023-16002391.88592.32
15min1168550-16855096.78292.873.0097.7293.723.05
2154995-15499588.99889.77
3160622-16062292.22993.09
4161982-16198293.01093.84
5158699-15869991.12591.86
6165582-16558295.07796.02
20min1168273-16827396.62295.181.9998.1096.542.04
2160481-16048192.14893.41
3163635-16363593.95995.33
4168306-16830696.64197.99
5165139-16513994.82396.06
6168710-16871096.87398.34
30min1166366-16636695.52795.841.0297.5497.731.01
2167452-16745296.15197.92
3163913-16391394.11996.02
4168438-16843896.71798.61
5166853-16685395.80797.57
6168470-16847096.73698.74
45min1165814-16581495.21195.550.3497.7597.970.35
2166001-16600195.31897.63
3166216-16621695.44197.86
4166224-16622495.44697.87
5166934-16693495.85498.15
6167237-16723796.02898.57
60min1163369-16336993.80794.241.6896.8897.191.54
2164872-16487294.67097.51
3164304-16430494.34397.29
4165126-16512694.81597.77
5167702-16770296.29599.12
6159335-15933591.49094.57
极限1161054-16105492.47794.322.8396.0797.802.69
2165776-16577695.18998.55
3156932-15693290.11093.59
4164832-16483294.64798.13
5170178-17017897.716101.08
6166787-16678795.76999.36
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