依折麦布匹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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.141327221335471329301332791331591331270.24
211.171343981350211347100.33
单位质量响应值RSD%判断
11950.3612059.980.65数据可信
供试品溶液-X013576批-匹伐他汀钙-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1159545-159545115.184128.037.85115.18128.027.85
2189324-189324136.683136.68
3173366-173366125.162125.16
4195659-195659141.257141.26
5165368-165368119.388119.39
6180730-180730130.479130.48
10min1314836-314836227.297232.861.27227.49233.081.28
2322933-322933233.143233.37
3325153-325153234.746234.95
4326358-326358235.615235.85
5324052-324052233.951234.15
6321947-321947232.431232.65
15min1351050-351050253.442254.820.93254.01255.420.93
2348241-348241251.414252.03
3357793-357793258.310258.91
4352317-352317254.357254.98
5354934-354934256.246256.83
6353414-353414255.149255.75
20min1363689-363689262.567263.011.06263.56264.031.05
2358981-358981259.168260.20
3370710-370710267.636268.67
4362590-362590261.773262.83
5365013-365013263.523264.54
6364803-364803263.371264.40
30min1374754-374754270.555269.741.19271.99271.211.18
2367327-367327265.193266.66
3380840-380840274.949276.43
4371613-371613268.287269.78
5373925-373925269.957271.41
6373295-373295269.502270.97
45min1378701-378701273.405273.351.26275.29275.261.25
2372814-372814269.155271.06
3387147-387147279.502281.44
4376523-376523271.832273.77
5379022-379022273.636275.54
6377551-377551272.574274.49
60min1379916-379916274.282273.981.41276.62276.351.40
2372029-372029268.588270.95
3388088-388088280.182282.58
4377526-377526272.556274.94
5381738-381738275.597277.96
6377662-377662272.655275.03
极限1381371-381371275.332273.991.08278.13276.821.07
2373445-373445269.610272.42
3385567-385567278.362281.23
4377069-377069272.226275.07
5379758-379758274.168276.99
6379880-379880274.256277.08
依折麦布匹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(%)100.0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%
111.37 3784213792773805343797753787143793440.23
211.353815473828033821750.24
单位质量响应值RSD%判断
33363.5933671.810.66数据可信
供试品溶液-X013576批-依折麦布-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
依折麦布匹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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.141335911329991331271343711338051335790.42
211.171339591348651344120.48
单位质量响应值RSD%判断
11990.9312033.300.25数据可信
供试品溶液-NB2A批-匹伐他汀钙-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min185068-8506861.37974.2312.6461.3874.2312.64
290167-9016765.05865.06
3105714-10571476.27576.28
4119696-11969686.36386.36
5105427-10542776.06876.07
6111199-11119980.23380.23
10min1129076-12907693.13195.581.5993.2395.701.60
2131127-13112794.61194.72
3134437-13443796.99997.13
4134599-13459997.11697.26
5132680-13268095.73295.86
6132908-13290895.89696.03
15min1134512-13451297.05497.340.6497.3197.630.64
2135304-13530497.62597.89
3136353-13635398.38298.67
4135001-13500197.40697.71
5133877-13387796.59596.88
6134444-13444497.00597.30
20min1135044-13504497.43797.270.6297.8697.720.62
2135146-13514697.51197.94
3136021-13602198.14298.60
4134953-13495397.37297.84
5133780-13378096.52596.97
6133966-13396696.66097.11
30min1134526-13452697.06497.050.5997.6597.660.58
2135325-13532597.64098.23
3135564-13556497.81398.43
4134088-13408896.74897.38
5133614-13361496.40697.01
6133905-13390596.61697.23
45min1133755-13375596.50796.840.6297.2597.610.62
2134964-13496497.38098.13
3135520-13552097.78198.56
4133883-13388396.60097.39
5133492-13349296.31897.09
6133670-13367096.44697.22
60min1134028-13402896.70496.650.6697.6197.580.66
2134622-13462297.13398.05
3135311-13531197.63098.57
4133578-13357896.38097.33
5132964-13296495.93796.87
6133251-13325196.14497.08
极限1133663-13366396.44196.400.5497.5197.490.54
2134012-13401296.69397.77
3134584-13458497.10698.21
4133727-13372796.48797.60
5132502-13250295.60396.69
6133134-13313496.05997.16
依折麦布匹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(%)100.0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%
111.37 3799613805593798543806973817583805660.20
211.353784493786423785460.04
单位质量响应值RSD%判断
33471.0633352.070.26数据可信
供试品溶液-NB2A批-依折麦布-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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