贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.26 3049883051163047993053033048183050050.07
210.25 3046993047803047400.02
单位质量响应值RSD%判断
29727.5829730.730.01数据可信
供试品溶液-2024090421批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1105449-10544935.37136.755.4135.3736.755.41
2117773-11777339.50439.50
3113187-11318737.96637.97
4104627-10462735.09535.09
5103194-10319434.61434.61
6113163-11316337.95837.96
10min1207137-20713769.48068.002.9369.5468.062.93
2196860-19686066.03266.10
3200055-20005567.10467.17
4212358-21235871.23171.29
5201933-20193367.73467.79
6198044-19804466.43066.49
15min1242831-24283181.45280.722.8481.6380.902.84
2234371-23437178.61578.79
3237272-23727279.58879.76
4253038-25303884.87685.05
5240736-24073680.75080.92
6235711-23571179.06479.24
20min1260734-26073487.45887.432.3087.7787.742.30
2255007-25500785.53785.84
3258411-25841186.67886.99
4271777-27177791.16291.48
5261399-26139987.68187.99
6256498-25649886.03786.34
30min1279258-27925893.67194.081.8394.1394.541.83
2276617-27661792.78593.23
3277902-27790293.21693.67
4289830-28983097.21797.69
5282734-28273494.83795.29
6276506-27650692.74893.20
45min1289057-28905796.95897.491.6397.5798.101.63
2285961-28596195.91996.52
3289401-28940197.07397.68
4298094-29809499.989100.62
5294527-29452798.79399.40
6286781-28678196.19496.80
60min1292859-29285998.23398.841.6699.0199.621.66
2290541-29054197.45698.22
3292457-29245798.09898.87
4302845-302845101.583102.38
5298343-298343100.073100.85
6290958-29095897.59698.36
极限1294940-29494098.931100.501.4199.87101.441.41
2296829-29682999.565100.49
3297924-29792499.932100.87
4305585-305585102.502103.47
5303926-303926101.945102.89
6298417-298417100.098101.02
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