多替诺雷非布司他片项目信息
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101278-202405对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.063000530020301573000430118300610.24
210.033043930648305440.49
单位质量响应值RSD%判断
2988.173045.261.34数据可信
供试品溶液-4229B批-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min174951-74951223.403208.9412.69223.40208.9412.69
266679-66679198.747198.75
378193-78193233.067233.07
472143-72143215.034215.03
574888-74888223.216223.22
653735-53735160.166160.17
10min1148763-148763443.412426.495.06443.78426.845.07
2144513-144513430.744431.08
3148845-148845443.656444.04
4143298-143298427.122427.48
5143914-143914428.958429.33
6129177-129177385.033385.30
15min1180011-180011536.551520.932.30537.66521.992.31
2175543-175543523.234524.28
3176754-176754526.843527.97
4174389-174389519.794520.86
5174095-174095518.918520.00
6167836-167836500.262501.17
20min1194302-194302579.148568.151.38581.15570.081.39
2192493-192493573.756575.68
3190598-190598568.108570.11
4190314-190314567.261569.20
5189278-189278564.173566.12
6186685-186685556.444558.19
30min1212399-212399633.089622.770.95636.06625.640.95
2209450-209450624.299627.18
3207072-207072617.211620.16
4207975-207975619.902622.78
5209358-209358624.025626.92
6207361-207361618.072620.74
45min1226438-226438674.934665.511.06678.96669.421.05
2224888-224888670.314674.23
3221376-221376659.846663.83
4222499-222499663.194667.11
5220159-220159656.219660.15
6224304-224304668.574672.27
60min1235069-235069700.660690.611.16705.81695.621.15
2232592-232592693.277698.31
3229061-229061682.753687.83
4231127-231127688.911693.93
5228375-228375680.708685.73
6233950-233950697.325702.14
90min1246726-246726735.406724.321.28741.72730.491.27
2245001-245001730.264736.45
3239800-239800714.762720.98
4242318-242318722.267728.44
5239127-239127712.756718.92
6245066-245066730.458736.43
极限1250968-250968748.050735.071.39755.59742.451.38
2247667-247667738.211745.62
3242684-242684723.358730.77
4246354-246354734.297741.67
5242677-242677723.337730.69
6249331-249331743.171750.36
多替诺雷非布司他片项目信息
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101278-202405对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.063057530682304713061230692306060.30
210.033079130781307860.03
单位质量响应值RSD%判断
3042.353069.390.63数据可信
供试品溶液-4229B批-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min183212-83212244.832202.6723.40244.83202.6723.40
275247-75247221.397221.40
349031-49031144.262144.26
448185-48185141.773141.77
574710-74710219.817219.82
682905-82905243.928243.93
10min1152539-152539448.810409.7810.99449.22410.1111.00
2146987-146987432.475432.84
3119270-119270350.924351.16
4120137-120137353.475353.71
5146912-146912432.254432.62
6149787-149787440.713441.12
15min1179270-179270527.460503.255.23528.62504.275.25
2176755-176755520.060521.15
3158846-158846467.367468.19
4160505-160505472.248473.07
5175271-175271515.694516.78
6175601-175601516.665517.81
20min1193810-193810570.240553.182.72572.28555.042.75
2190256-190256559.784561.74
3181054-181054532.709534.31
4182292-182292536.351537.96
5190137-190137559.433561.38
6190516-190516560.549562.55
30min1210074-210074618.093609.171.10621.08611.951.12
2209021-209021614.995617.88
3204449-204449601.543604.04
4205213-205213603.791606.30
5207780-207780611.344614.22
6205702-205702605.230608.17
45min1223771-223771658.394654.010.64662.41657.800.63
2222787-222787655.498659.41
3221790-221790652.565656.06
4223153-223153656.575660.09
5222418-222418654.413658.31
6219760-219760646.592650.54
60min1232293-232293683.468679.970.89688.58684.860.87
2231227-231227680.331685.34
3231640-231640681.546686.13
4233231-233231686.227690.83
5230948-230948679.510684.50
6227290-227290668.747673.77
90min1244649-244649719.822714.031.11726.07720.051.09
2241852-241852711.593717.73
3242327-242327712.990718.71
4244465-244465719.281725.03
5244896-244896720.549726.67
6237891-237891699.938706.08
极限1246464-246464725.162724.250.78732.61731.460.75
2246924-246924726.516733.84
3246993-246993726.719733.63
4248260-248260730.447737.40
5245558-245558722.497729.82
6242718-242718714.141721.44
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