替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号0100320240115对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.237560767561277571837568447572817567020.08
211.257534477540597537530.06
单位质量响应值RSD%判断
67382.1967000.270.41数据可信
供试品溶液-24101501批-pH7.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1194757-19475726.08724.425.0126.0924.425.02
2181233-18123324.27624.28
3177609-17760923.79023.79
4170326-17032622.81522.81
5178613-17861323.92523.92
6191348-19134825.63125.63
10min1357720-35772047.91644.264.7748.0644.404.77
2323511-32351143.33343.47
3320376-32037642.91343.05
4312970-31297041.92142.05
5331351-33135144.38444.52
6336768-33676845.10945.25
15min1487274-48727465.26961.274.5365.6861.654.53
2439467-43946758.86559.24
3456755-45675561.18161.55
4432018-43201857.86858.23
5474100-47410063.50463.88
6454886-45488660.93161.32
20min1583149-58314978.11174.844.6378.8875.564.62
2535233-53523371.69372.40
3558067-55806774.75175.46
4532178-53217871.28471.96
5595733-59573379.79780.53
6548042-54804273.40974.14
30min1714947-71494795.76591.843.5396.9792.983.53
2653092-65309287.48088.58
3683122-68312291.50292.63
4678882-67888290.93492.01
5712840-71284095.48396.66
6670908-67090889.86691.01
45min1756550-756550101.338101.601.07103.08103.251.08
2757825-757825101.508103.10
3753682-753682100.954102.59
4757005-757005101.399102.98
5774357-774357103.723105.43
6751679-751679100.685102.32
60min1731360-73136097.964100.961.58100.27103.181.52
2757250-757250101.431103.58
3760626-760626101.884104.08
4754853-754853101.110103.26
5765648-765648102.556104.84
6752824-752824100.839103.04
极限1761162-761162101.955101.461.00104.80104.241.00
2761866-761866102.050104.76
3744177-74417799.680102.44
4755687-755687101.222103.93
5765789-765789102.575105.43
6756314-756314101.306104.06
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