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125
标示量(mg)100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%
117.41 2420232413002413832411512407612413240.19
217.402410552417592414070.21
单位质量响应值RSD%判断
13861.2313873.970.07数据可信
长期30℃12月-供试品溶液-2023052611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%
5min1266665-26666597.36797.571.8997.3797.571.89
2263515-26351596.21796.22
3268142-26814297.90697.91
4274697-274697100.300100.30
5260277-26027795.03595.03
6270073-27007398.61198.61
10min1264666-26466696.63798.691.4796.8098.861.47
2266964-26696497.47697.64
3270758-27075898.86299.02
4275828-275828100.713100.88
5271567-27156799.15799.32
6272023-27202399.32399.49
15min1268237-26823797.94198.762.0698.2699.082.05
2265804-26580497.05397.38
3278109-278109101.546101.87
4274823-274823100.346100.68
5263620-26362096.25596.58
6272240-27224099.40399.73
20min1267374-26737497.62697.891.4998.1198.381.49
2266319-26631997.24197.73
3268402-26840298.00198.50
4273319-27331999.797100.30
5261914-26191495.63296.12
6271201-27120199.02399.52
30min1267622-26762297.71798.041.7398.3798.701.73
2263404-26340496.17696.82
3268321-26832197.97298.63
4274360-274360100.177100.85
5263880-26388096.35096.99
6273493-27349399.860100.52
45min1264819-26481996.69398.542.6697.5199.362.65
2263752-26375296.30397.11
3270791-27079198.87499.70
4275382-275382100.550101.39
5263542-26354296.22797.03
6280935-280935102.578103.40
极限1268282-26828297.95898.201.6098.9399.181.60
2264824-26482496.69597.66
3269226-26922698.30299.29
4276073-276073100.802101.81
5264422-26442296.54897.51
6270800-27080098.87799.87
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125
标示量(mg)100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%
117.41 2415522418072414212414652413792415250.08
217.402412692410272411480.08
单位质量响应值RSD%判断
13872.7713859.080.07数据可信
长期30℃12月-供试品溶液-2023052711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%
5min1263846-26384696.34997.351.0996.3597.351.09
2270004-27000498.59898.60
3268819-26881998.16598.17
4263038-26303896.05496.05
5265291-26529196.87796.88
6268442-26844298.02898.03
10min1266879-26687997.45798.290.9597.6298.460.95
2270835-27083598.90299.07
3272805-27280599.62199.78
4267885-26788597.82497.98
5266317-26631797.25297.41
6270312-27031298.71198.87
15min1265791-26579197.06097.960.8697.3898.290.86
2272229-27222999.41199.74
3269495-26949598.41298.74
4266986-26698697.49697.82
5267034-26703497.51497.84
6268083-26808397.89798.22
20min1267366-26736697.63598.201.1798.1298.681.17
2274459-274459100.225100.72
3268665-26866598.10998.60
4266165-26616597.19697.68
5266382-26638297.27697.76
6270392-27039298.74099.23
30min1265728-26572897.03797.790.8897.6898.440.88
2271817-27181799.26099.92
3268196-26819697.93898.60
4265842-26584297.07897.73
5266380-26638097.27597.92
6268784-26878498.15398.81
45min1265388-26538896.91397.911.2597.7298.731.25
2273375-27337599.829100.66
3267227-26722797.58498.40
4269241-26924198.32099.13
5263989-26398996.40297.21
6269506-26950698.41699.24
极限1265247-26524796.86197.731.0297.8398.711.01
2271216-27121699.041100.03
3265458-26545896.93897.92
4264965-26496596.75897.73
5269605-26960598.45299.42
6269266-26926698.32999.31
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125
标示量(mg)100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%
117.41 2412302403132411112409342408152408810.15
217.402418112418592418350.02
单位质量响应值RSD%判断
13835.7813898.560.33数据可信
长期30℃12月-供试品溶液-2023052811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%
5min1271404-27140499.10196.611.6299.1096.611.61
2259050-25905094.59094.59
3263501-26350196.21596.22
4261837-26183795.60895.61
5264936-26493696.73996.74
6266783-26678397.41497.41
10min1277439-277439101.30598.181.94101.4798.351.94
2262004-26200495.66995.83
3268164-26816497.91898.08
4265483-26548396.93997.10
5270345-27034598.71498.88
6269910-26991098.55598.72
15min1282122-282122103.01598.532.41103.3598.862.41
2265812-26581297.05997.38
3269115-26911598.26598.59
4263387-26338796.17496.49
5268446-26844698.02198.35
6270196-27019698.66098.99
20min1274945-274945100.39498.722.42100.9099.202.41
2266581-26658197.34097.82
3266926-26692697.46697.95
4262696-26269695.92196.40
5270244-27024498.67799.17
6280715-280715102.501102.99
30min1272343-27234399.44497.581.19100.1298.231.20
2263093-26309396.06696.71
3265513-26551396.95097.60
4267590-26759097.70898.35
5265995-26599597.12697.78
6268855-26885598.17098.83
45min1271417-27141799.10696.811.7399.9497.621.73
2258970-25897094.56195.36
3266907-26690797.45998.27
4260765-26076595.21696.02
5265312-26531296.87797.69
6267332-26733297.61498.44
极限1273424-27342499.83997.581.75100.8498.551.74
2261184-26118495.36996.33
3268600-26860098.07799.05
4262315-26231595.78296.74
5269816-26981698.52199.50
6268042-26804297.87398.86
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