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100629-202204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%
111.234926844998445000235007625000374986700.68
211.255033945011645022790.32
单位质量响应值RSD%判断
44405.1644647.020.39数据可信
供试品溶液-24120601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%
5min1223413-22341345.15937.5713.1645.1637.5713.17
2167491-16749133.85533.85
3167545-16754533.86633.87
4209200-20920042.28642.29
5167933-16793333.94433.94
6179535-17953536.28936.29
10min1370677-37067774.92567.388.1875.1867.608.19
2311916-31191663.04863.24
3311499-31149962.96363.15
4365247-36524773.82774.06
5316622-31662263.99964.19
6324279-32427965.54765.75
15min1440620-44062089.06385.454.0289.7386.044.05
2409139-40913982.69983.24
3409715-40971582.81683.35
4445600-44560090.06990.71
5407219-40721982.31182.86
6424291-42429185.76286.33
20min1468588-46858894.71694.340.6895.8895.400.73
2464698-46469893.92994.93
3464953-46495393.98194.98
4471041-47104195.21296.36
5468400-46840094.67895.68
6462554-46255493.49694.54
30min1458544-45854492.68693.941.1994.3795.521.11
2472234-47223495.45396.97
3464081-46408193.80595.32
4461428-46142893.26994.94
5470667-47066795.13696.66
6461426-46142693.26894.83
45min1466532-46653294.30093.292.0396.5095.401.98
2468552-46855294.70896.76
3455383-45538392.04794.09
4455656-45565692.10294.29
5473692-47369295.74797.80
6449510-44951090.86092.94
60min1456288-45628892.23090.702.1994.9693.322.12
2448393-44839390.63493.21
3443994-44399489.74592.30
4434479-43447987.82190.53
5462635-46263593.51296.10
6446462-44646290.24392.83
极限1420888-42088885.07486.501.9888.3189.631.90
2436695-43669588.26991.35
3414897-41489783.86386.91
4428707-42870786.65589.85
5432016-43201687.32390.43
6434553-43455387.83690.92
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