盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.423967843971373967903965833966703967930.06
212.343975763973223974490.05
单位质量响应值RSD%判断
31947.9132208.180.58数据可信
长期3月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023120221批1428300-428300101.20100.240.9799.23%～101.26%
2427614-427614101.04
3419177-41917799.05
4419097-41909799.03
5425829-425829100.62
6425447-425447100.53
2023120521批1419563-41956399.1499.723.6695.89%～103.54%
2418816-41881698.96
3440536-440536104.10
4440438-440438104.07
5406203-40620395.98
6406438-40643896.04
2023120621批1417100-41710098.5697.551.6295.89%～99.20%
2416681-41668198.46
3417582-41758298.67
4417154-41715498.57
5403875-40387595.43
6404578-40457895.60
2205008609批1401458-40145894.8695.541.0094.54%～96.53%
2401324-40132494.83
3402277-40227795.06
4401830-40183094.95
5409351-40935196.73
6409554-40955496.78
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.423965963963573963913957803962043962660.08
212.343953553953483953520.01
单位质量响应值RSD%判断
31905.4832038.250.30数据可信
加速3月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023120221批1417634-41763499.0198.631.4797.11%～100.15%
2417184-41718498.90
3422231-422231100.10
4421877-421877100.02
5408575-40857596.86
6408640-40864096.88
2023120521批1417907-41790799.0898.300.6597.64%～98.96%
2418173-41817399.14
3412577-41257797.81
4412960-41296097.90
5413404-41340498.01
6412779-41277997.86
2023120621批1416740-41674098.8097.681.2296.43%～98.93%
2417078-41707898.88
3413294-41329497.98
4413211-41321197.96
5405799-40579996.21
6405955-40595596.24
2205008609批1406598-40659896.3996.141.4494.69%～97.59%
2405926-40592696.24
3398788-39878894.54
4398570-39857094.49
5411490-41149097.55
6411771-41177197.62
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.423962123960583962483959423961643961250.04
212.343965703965103965400.02
单位质量响应值RSD%判断
31894.1232134.520.54数据可信
-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023120221批1414616-41461698.1799.531.0798.42%～100.64%
2415040-41504098.27
3421684-42168499.84
4421846-42184699.88
5424234-424234100.44
6424821-424821100.58
2023120521批1414248-41424898.0898.741.0397.68%～99.80%
2414070-41407098.04
3422286-42228699.98
4422785-422785100.10
5414662-41466298.18
6414126-41412698.05
2023120621批1431931-431931102.2798.844.9793.69%～104.00%
2433583-433583102.66
3390588-39058892.48
4391018-39101892.58
5428953-428953101.56
6428746-428746101.51
2205008609批1429198-429198101.6299.691.6497.98%～101.40%
2429217-429217101.62
3419933-41993399.43
4420226-42022699.49
5413922-41392298.00
6413837-41383797.98
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