依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.044742454741474742214742894740764741960.02
211.024740144742904741520.05
单位质量响应值RSD%判断
42952.5443026.500.13数据可信
加速3月-供试品溶液-瑞舒伐他汀钙-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121148169248197348183295.7797.792.7994.94%～100.65%
248919348916448917897.23
3504372504614504493100.28
4512431512331512381101.85
547690147688747689494.79
648722848705148714096.83
2024030221150068250051750060099.50100.892.2198.55%～103.22%
2503569503362503466100.07
3504276504324504300100.24
449662949658749660898.71
5512786512776512781101.92
6527510527778527644104.88
20240303211510426510124510275101.43102.851.87100.84%～104.86%
2511069510657510863101.54
3520629520415520522103.46
4522907522705522806103.92
5532797532552532674105.88
6507277507526507402100.86
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.004279674298124282284285004284064285830.17
211.014274734273814274270.02
单位质量响应值RSD%判断
38962.0938821.710.26数据可信
加速3月-供试品溶液-依折麦布-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211441856442193442024102.2998.504.0194.36%～102.64%
2440112439674439893101.80
342030342041442035897.28
439526039538439532291.48
543144343154743149599.85
642485242466142475698.29
20240302211436763436619436691101.0699.422.9596.35%～102.49%
2438384438259438322101.43
3437995437821437908101.34
440928740973340951094.77
541764841797941781496.69
6437499437342437420101.22
2024030321141367741349041358495.7198.902.6196.20%～101.60%
2433640433554433597100.34
3434571434111434341100.51
442179042198442188797.63
5442469442591442530102.41
641823741843441833696.81
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.044745734746964748164745354743504745940.04
211.024734264733594733920.02
单位质量响应值RSD%判断
42988.5942957.530.06数据可信
中间条件3月-供试品溶液-瑞舒伐他汀钙-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211509216509231509224101.26101.821.7999.91%～103.73%
250158350147650153099.73
3522088522045522066103.81
4521596521363521480103.69
5516048515822515935102.59
650201250243250222299.86
20240302211509972511858510915101.59101.731.13100.52%～102.93%
250241850245050243499.91
3518724518938518831103.17
4509231507147508189101.05
5514079514164514122102.23
6515189514830515010102.41
20240303211512430511956512193101.85101.891.8199.96%～103.83%
2523661523855523758104.15
3512370512829512600101.93
4506618506842506730100.76
549836749839149837999.10
6520785520980520882103.57
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.004276194272644273514275554275074274590.04
211.014281414283814282610.04
单位质量响应值RSD%判断
38859.9138897.460.07数据可信
中间条件3月-供试品溶液-依折麦布-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211441228440496440862102.05100.141.2198.87%～101.40%
2436316436327436322101.00
342744642713042728898.91
443031043053243042199.64
542789742809842799899.08
6432753432413432583100.14
20240302211441277441961441619102.23101.022.7198.16%～103.89%
2436581436306436444101.03
3455258455102455180105.37
4437390437364437377101.25
542342842357042349998.04
642431942415142423598.21
2024030321142285442255242270397.85100.131.6398.43%～101.83%
2434616434889434752100.64
3439050439046439048101.63
4432308432680432494100.12
542619742596242608098.63
6440401440169440285101.92
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