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%
111.141332751333661334061333561333211333450.04
211.171348651346621347640.11
单位质量响应值RSD%判断
11969.9312064.820.56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%
5min1188627-188627136.041130.688.88136.04130.688.88
2203502-203502146.769146.77
3184458-184458133.034133.03
4184907-184907133.358133.36
5158360-158360114.212114.21
6167294-167294120.655120.66
10min1327547-327547236.233231.332.50236.46231.552.50
2332872-332872240.073240.32
3320396-320396231.075231.30
4313808-313808226.324226.55
5317132-317132228.721228.91
6312713-312713225.534225.74
15min1359597-359597259.348256.650.89259.97257.250.90
2359309-359309259.140259.78
3353377-353377254.862255.47
4352932-352932254.541255.14
5356916-356916257.414257.99
6352968-352968254.567255.14
20min1370152-370152266.960265.880.55268.01266.910.55
2370206-370206266.999268.08
3367392-367392264.969266.00
4366017-366017263.978265.00
5370908-370908267.505268.51
6367231-367231264.853265.85
30min1380882-380882274.699273.160.62276.20274.640.62
2379893-379893273.985275.51
3376781-376781271.741273.21
4375785-375785271.023272.49
5381515-381515275.155276.60
6377674-377674272.385273.83
45min1384312-384312277.172276.540.62279.13278.470.62
2385035-385035277.694279.67
3382197-382197275.647277.57
4380078-380078274.119276.03
5386613-386613278.832280.74
6382364-382364275.767277.66
60min1386697-386697278.893277.070.70281.31279.460.71
2385969-385969278.367280.81
3383057-383057276.267278.65
4381566-381566275.192277.56
5386873-386873279.019281.39
6380850-380850274.676277.03
极限1385974-385974278.371276.950.72281.25279.800.72
2386232-386232278.557281.46
3382717-382717276.022278.87
4379947-379947274.024276.86
5386814-386814278.977281.81
6382302-382302275.723278.54
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%
111.373808583806003807363805703808023807130.04
211.353842213841003841600.03
单位质量响应值RSD%判断
33483.9933846.700.77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%
111.141340871342431340671341231343481341740.09
211.171345131346971346050.10
单位质量响应值RSD%判断
12044.3412050.580.04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%
5min179863-7986357.45470.5711.0257.4570.5711.02
299463-9946371.55471.55
399785-9978571.78671.79
493268-9326867.09767.10
5111489-11148980.20680.21
6104712-10471275.33075.33
10min1120575-12057586.74292.713.6986.8492.833.70
2132341-13234195.20795.33
3127863-12786391.98592.10
4127195-12719591.50591.62
5132572-13257295.37395.51
6132701-13270195.46695.59
15min1131747-13174794.77996.080.8195.0296.350.82
2134263-13426396.58996.87
3133729-13372996.20596.48
4132939-13293995.63795.90
5133833-13383396.28096.57
6134791-13479196.96997.25
20min1132777-13277795.52096.530.6395.9296.960.65
2134549-13454996.79597.23
3135239-13523997.29297.72
4133693-13369396.17996.60
5134316-13431696.62897.08
6134475-13447596.74297.19
30min1132314-13231495.18796.490.8295.7497.080.84
2134019-13401996.41497.01
3135662-13566297.59698.19
4133959-13395996.37196.95
5134053-13405396.43897.05
6134722-13472296.92097.53
45min1132772-13277295.51796.380.8196.2397.130.82
2134211-13421196.55297.31
3135744-13574497.65598.41
4132918-13291895.62296.37
5133879-13387996.31397.09
6134300-13430096.61697.39
60min1132450-13245095.28596.250.7496.1697.170.75
2133894-13389496.32497.25
3135342-13534297.36698.29
4133198-13319895.82396.73
5133577-13357796.09697.03
6134299-13429996.61597.55
极限1132376-13237695.23295.940.6196.2797.020.61
2133607-13360796.11797.20
3134681-13468196.89097.97
4133210-13321095.83296.90
5133571-13357196.09297.19
6132733-13273395.48996.58
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%
111.373840183837713830943829783833143834350.12
211.353829113853203841160.45
单位质量响应值RSD%判断
33723.3933842.820.25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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