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%
110.021680011676681676231675361674231676500.13
210.031685261690861688060.24
单位质量响应值RSD%判断
16731.5416830.110.42数据可信
供试品溶液-2024011222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%
5min170707-7070737.79738.4636.6937.8038.4636.69
244935-4493524.02124.02
375202-7520240.20040.20
443752-4375223.38823.39
5114834-11483461.38661.39
682278-8227843.98343.98
10min1156955-15695583.90281.3812.2684.1181.5912.32
2120894-12089464.62564.76
3155569-15556983.16183.38
4143801-14380176.87077.00
5176799-17679994.51094.85
6159358-15935885.18785.43
15min1178971-17897195.67194.974.8496.3595.644.93
2161697-16169786.43786.93
3178997-17899795.68596.37
4177320-17732094.78895.35
5187368-187368100.160101.03
6181641-18164197.09897.82
20min1182048-18204897.31698.393.5298.5299.583.61
2172409-17240992.16393.14
3185097-18509798.946100.16
4185046-18504698.918100.00
5189527-189527101.314102.74
6190206-190206101.677102.93
30min1183663-18366398.179100.282.3199.93102.022.35
2182199-18219997.39798.88
3190867-190867102.030103.80
4188049-188049100.524102.16
5187019-18701999.973101.96
6193722-193722103.556105.38
45min1182222-18222297.409100.071.6299.70102.361.67
2184927-18492798.855100.88
3188125-188125100.564102.90
4189614-189614101.360103.55
5190050-190050101.593104.13
6188255-188255100.634103.03
60min1186889-18688999.904101.542.21102.74104.392.02
2198250-198250105.977108.55
3188728-188728100.887103.78
4189267-189267101.175103.93
5187235-187235100.089103.19
6189310-189310101.198104.15
极限1186953-18695399.938100.250.90103.33103.670.90
2185618-18561899.224102.39
3188404-188404100.713104.17
4190325-190325101.740105.06
5187567-187567100.266103.93
6186356-18635699.619103.14
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%
111.171578681577721579981577651577011578210.08
211.111588121590651589380.12
单位质量响应值RSD%判断
14129.0114305.850.88数据可信
供试品溶液-2024011222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%
5min167076-6707638.97162.9821.1038.9762.9821.10
2130660-13066075.91375.91
3108028-10802862.76462.76
4127238-12723873.92573.93
5113919-11391966.18766.19
6103425-10342560.09060.09
10min1123020-12302071.47589.3010.8471.6989.6610.87
2166484-16648496.72797.15
3150116-15011687.21787.57
4165386-16538696.08996.50
5152111-15211188.37688.74
6165139-16513995.94696.28
15min1145738-14573884.67495.396.4985.2996.246.56
2175077-175077101.720102.68
3158658-15865892.18093.01
4170835-17083599.255100.20
5164906-16490695.81096.67
6169905-16990598.71599.58
20min1154681-15468189.87096.253.9990.9597.624.08
2170104-17010498.830100.35
3160755-16075593.39994.74
4170565-17056599.098100.59
5166903-16690396.97198.36
6170934-17093499.313100.73
30min1158993-15899392.37597.192.5093.9699.102.60
2168973-16897398.173100.25
3169383-16938398.411100.28
4167773-16777397.47699.52
5168200-16820097.72499.65
6170397-17039799.001100.97
45min1158948-15894892.34996.612.2894.4599.062.40
2168129-16812997.683100.30
3165924-16592496.40298.81
4167351-16735197.23199.82
5167793-16779397.48899.96
6169573-16957398.522101.04
60min1168658-16865897.99098.041.42100.60101.021.44
2172186-172186100.040103.20
3166362-16636296.65699.60
4169598-16959898.536101.66
5169851-16985198.683101.70
6165757-16575796.30599.37
极限1165312-16531296.04697.211.0099.20100.751.10
2167662-16766297.412101.13
3167919-16791997.561101.04
4168021-16802197.620101.30
5165412-16541296.10499.67
6169614-16961498.546102.15
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