玛巴洛沙韦干混悬剂项目信息
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115240801对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.6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%
1 11.211001752997423100177110003150.26
2 11.17999389100406510017270.34
单位质量响应值RSD%判断
89234.1789680.130.36数据可信
供试品溶液-24103001批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1297489-29748930.10929.844.0430.1129.844.03
2299744-29974430.33730.34
3303750-30375030.74330.74
4296839-29683930.04330.04
5271069-27106927.43527.44
6300057-30005730.36930.37
10min1371678-37167837.61836.962.6837.6737.012.68
2364662-36466236.90836.96
3373035-37303537.75537.81
4367315-36731537.17637.23
5346205-34620535.04035.09
6367879-36787937.23337.28
15min1410060-41006041.50340.762.1341.6240.882.14
2400835-40083540.56940.68
3408595-40859541.35441.47
4406361-40636141.12841.24
5386595-38659539.12839.23
6404144-40414440.90441.02
20min1435326-43532644.06043.281.7544.2443.461.76
2421772-42177242.68842.87
3433510-43351043.87644.06
4431364-43136443.65943.84
5415917-41591742.09542.26
6428006-42800643.31943.50
30min1461617-46161746.72145.891.3546.9846.141.35
2448400-44840045.38345.63
3457146-45714646.26846.52
4456014-45601446.15446.41
5445066-44506645.04645.29
6451928-45192845.74045.99
极限1527087-52708753.34753.030.5753.6853.360.56
2522398-52239852.87253.20
3521717-52171752.80453.14
4524205-52420553.05553.39
5527771-52777153.41653.73
6520447-52044752.67553.00
玛巴洛沙韦干混悬剂项目信息
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115240801对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.6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%
1 11.211004219100659210033311002679100311610039870.16
2 11.171002629101205410073420.67
单位质量响应值RSD%判断
89561.7390182.810.49数据可信
供试品溶液-24103001批-pH6.8(内含%CTAB)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1452115-45211545.54846.584.6845.5546.584.68
2469021-46902147.25147.25
3463454-46345446.69046.69
4471520-47152047.50347.50
5491461-49146149.51249.51
6426879-42687943.00643.01
10min1559570-55957056.37357.663.5956.4557.743.59
2585214-58521458.95759.04
3574555-57455557.88357.96
4574932-57493257.92158.00
5599619-59961960.40860.49
6540366-54036654.43954.51
15min1614866-61486661.94463.502.9862.1163.672.99
2645599-64559965.04065.22
3634750-63475063.94764.12
4628200-62820063.28763.46
5654253-65425365.91266.10
6604116-60411660.86161.02
20min1649787-64978765.46266.862.8265.7467.142.82
2681568-68156868.66468.95
3666793-66679367.17667.46
4659792-65979266.47066.75
5686339-68633969.14569.44
6637403-63740364.21564.48
30min1704379-70437970.96271.562.5971.3471.952.59
2730119-73011973.55573.96
3713906-71390671.92272.31
4698698-69869870.39070.78
5730845-73084573.62874.04
6684076-68407668.91769.29
极限1984617-98461799.194100.292.8099.69100.802.79
21046663-1046663105.445105.97
3995507-995507100.292100.80
4986235-98623599.35799.87
5996929-996929100.435100.97
6963287-96328797.04697.53
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