恩格列净片项目信息
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数400
标示量(mg)25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%
110.28 5681595681305681845679605679845680830.02
210.215670735671295671010.01
单位质量响应值RSD%判断
55260.9955543.680.37数据可信
供试品溶液-2024052811批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1457824-45782473.62270.685.4773.6270.685.47
2438159-43815970.46070.46
3435881-43588170.09370.09
4428654-42865468.93168.93
5473053-47305376.07176.07
6403521-40352164.89064.89
10min1545918-54591887.78889.441.9287.9189.551.92
2562304-56230490.42390.54
3560136-56013690.07590.19
4544407-54440787.54587.66
5572125-57212592.00292.13
6552096-55209688.78288.89
15min1563245-56324590.57493.842.5190.8494.102.51
2589014-58901494.71894.99
3590050-59005094.88595.15
4574926-57492692.45392.71
5605578-60557897.38297.66
6578319-57831992.99993.25
20min1571269-57126991.86595.592.6792.2896.012.67
2607061-60706197.62098.05
3599503-59950396.40596.83
4587202-58720294.42794.84
5614975-61497598.89399.34
6586569-58656994.32594.74
30min1621857-621857100.00098.912.36100.5799.502.36
2614279-61427998.78199.37
3637228-637228102.472103.06
4598164-59816496.19096.76
5618641-61864199.483100.09
6600415-60041596.55297.12
45min1589143-58914394.73997.862.0395.4898.612.03
2620275-62027599.745100.50
3611922-61192298.40299.16
4603311-60331197.01797.75
5622321-622321100.074100.85
6604400-60440097.19397.92
60min1592847-59284795.33598.341.7896.2399.241.78
2620443-62044399.772100.69
3615415-61541598.96499.88
4613734-61373498.69499.59
5621579-62157999.955100.89
6605018-60501897.29298.18
极限1606679-60667997.55998.891.4198.6299.961.42
2620573-62057399.793100.88
3617049-61704999.227100.31
4612244-61224498.45499.51
5627846-627846100.963102.07
6605201-60520197.32198.37
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