艾托格列净片项目信息
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741-2407001-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(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.813867943852043850323875453868293862810.29
214.863841473854463847960.24
单位质量响应值RSD%判断
26082.4425894.750.52数据可信
供试品溶液-2026032321批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1269751-26975171.67667.654.1471.6867.654.14
2257061-25706168.30468.30
3258193-25819368.60568.61
4241996-24199664.30164.30
5257655-25765568.46268.46
6242867-24286764.53364.53
10min1328493-32849387.28581.993.7887.4082.103.78
2309948-30994882.35782.47
3310304-31030482.45282.57
4294219-29421978.17878.28
5308182-30818281.88882.00
6300264-30026479.78479.89
15min1351045-35104593.27787.183.7893.5487.423.78
2328205-32820587.20887.46
3327311-32731186.97187.22
4314796-31479683.64583.88
5327033-32703386.89787.15
6320125-32012585.06185.30
20min1363215-36321596.51190.143.8196.9390.533.81
2337192-33719289.59689.99
3337672-33767289.72490.12
4324173-32417386.13786.51
5339094-33909490.10290.50
6334074-33407488.76889.15
30min1373254-37325499.17893.163.7699.7693.713.76
2352435-35243593.64794.19
3348369-34836992.56693.11
4332587-33258788.37388.89
5350877-35087793.23393.78
6346151-34615191.97792.51
45min1380993-380993101.23595.573.50101.9896.273.50
2359531-35953195.53296.23
3356682-35668294.77595.48
4342372-34237290.97391.64
5363025-36302596.46097.16
6355501-35550194.46195.14
60min1382763-382763101.70596.243.55102.6297.103.55
2360908-36090895.89896.76
3359811-35981195.60696.46
4344125-34412591.43892.26
5368609-36860997.94498.81
6356921-35692194.83995.68
极限1388410-388410103.20698.353.19104.2999.373.20
2369555-36955598.19699.22
3365256-36525697.05398.07
4356176-35617694.64195.61
5379189-379189100.755101.78
6362314-36231496.27297.27
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