枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.362385922384802386262383512379432383980.12
217.312383272383432383350.01
单位质量响应值RSD%判断
13732.6013768.630.19数据可信
供试品溶液-2024051611批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1271973-271973100.150100.012.09100.15100.012.08
2263208-26320896.92396.92
3274933-274933101.240101.24
4267513-26751398.50898.51
5279371-279371102.874102.87
6272554-272554100.364100.36
10min1274687-274687101.150100.352.30101.32100.522.30
2264635-26463597.44897.61
3276775-276775101.918102.09
4270149-27014999.47999.64
5281441-281441103.637103.81
6267429-26742998.47798.64
15min1274122-274122100.942100.052.33101.28100.392.33
2263871-26387197.16797.49
3276045-276045101.650101.99
4269818-26981899.35799.69
5280432-280432103.265103.61
6265930-26593097.92598.26
20min1273424-273424100.68499.682.49101.19100.182.49
2263653-26365397.08697.57
3275790-275790101.556102.06
4268839-26883998.99699.49
5279573-279573102.949103.47
6262867-26286796.79797.29
30min1272633-272633100.39399.532.33101.06100.202.33
2262200-26220096.55197.20
3274917-274917101.234101.91
4268739-26873998.95999.62
5278651-278651102.609103.30
6264616-26461697.44198.10
45min1271691-271691100.04699.732.09100.89100.562.10
2262040-26204096.49397.30
3274048-274048100.914101.76
4268060-26806098.70999.53
5278810-278810102.668103.53
6270289-27028999.530100.35
极限1271085-27108599.82399.302.33100.83100.302.33
2261770-26177096.39397.36
3274407-274407101.046102.06
4268137-26813798.73899.73
5278443-278443102.533103.56
6264183-26418397.28298.27
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.362379342377552380652374242376712377700.11
217.312377782380552379160.09
单位质量响应值RSD%判断
13696.4313744.430.25数据可信
供试品溶液-2024051611批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1261910-26191096.65798.871.9696.6698.871.96
2267584-26758498.75198.75
3275159-275159101.546101.55
4268016-26801698.91098.91
5262490-26249096.87196.87
6272222-272222100.463100.46
10min1264484-26448497.60799.791.7497.7799.961.74
2271095-271095100.047100.21
3273851-273851101.064101.23
4270976-270976100.003100.17
5265441-26544197.96098.12
6276583-276583102.072102.24
15min1264344-26434497.55599.551.7697.8899.881.76
2270688-27068899.896100.23
3273263-273263100.847101.18
4269985-26998599.63799.97
5264194-26419497.50097.82
6275970-275970101.846102.18
20min1263538-26353897.25899.361.8297.7499.861.82
2270584-27058499.858100.36
3272862-272862100.699101.20
4269296-26929699.38399.88
5263577-26357797.27297.76
6275562-275562101.695102.20
30min1263035-26303597.07299.211.8097.7299.871.80
2269831-26983199.580100.24
3271613-271613100.238100.91
4269353-26935399.404100.07
5263503-26350397.24597.89
6275562-275562101.695102.37
45min1262532-26253296.88798.901.7297.7099.721.72
2269790-26979099.565100.40
3270517-27051799.833100.67
4268462-26846299.07599.90
5262570-26257096.90197.71
6274020-274020101.126101.97
极限1265731-26573198.06799.021.4899.04100.021.48
2269632-26963299.507100.50
3270451-27045199.809100.82
4267995-26799598.90399.90
5262376-26237696.82997.80
6273756-273756101.029102.04
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