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%
117.279536509533679541259545869537249538900.05
217.239518179519879519020.02
单位质量响应值RSD%判断
55233.9355246.780.02数据可信
供试品溶液-2024051911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%
5min1913667-91366783.74993.205.0083.7593.205.00
21034757-103475794.84894.85
31040088-104008895.33795.34
41038206-103820695.16495.16
51044955-104495595.78395.78
61028759-102875994.29894.30
10min11087368-108736899.67198.940.8899.8199.100.88
21074240-107424098.46798.63
31069834-106983498.06398.22
41088403-108840399.76699.92
51088039-108803999.73299.89
61068822-106882297.97198.13
15min11106115-1106115101.389100.011.04101.69100.331.03
21084896-108489699.44499.77
31080161-108016199.01099.33
41096306-1096306100.490100.81
51099941-1099941100.823101.15
61078873-107887398.89299.21
20min11111441-1111441101.87799.921.39102.35100.401.38
21089187-108918799.837100.33
31084043-108404399.36699.85
41069301-106930198.01598.51
51103195-1103195101.121101.62
61083199-108319999.28999.77
30min11109764-1109764101.724100.431.05102.37101.081.05
21082457-108245799.22199.87
31087914-108791499.721100.37
41104246-1104246101.218101.87
51103449-1103449101.145101.81
61086298-108629899.573100.22
45min11107557-1107557101.521100.221.03102.34101.041.03
21080705-108070599.06099.88
31084687-108468799.425100.24
41101005-1101005100.921101.75
51101425-1101425100.959101.79
61084985-108498599.452100.27
极限11105808-1105808101.361100.150.99102.34101.130.98
21081064-108106499.093100.08
31084689-108468999.425100.41
41099805-1099805100.811101.80
51100777-1100777100.900101.90
61083202-108320299.289100.27
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%
117.279527639524289529949526219516589524930.06
217.239538009536279537140.02
单位质量响应值RSD%判断
55153.0455351.940.26数据可信
供试品溶液-2024051911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%
5min11011073-101107392.65793.961.3192.6693.961.31
21020186-102018693.49293.49
31035428-103542894.88994.89
41038534-103853495.17495.17
51037120-103712095.04495.04
61009626-100962692.52592.52
10min11050321-105032196.25497.681.6496.4197.841.64
21052164-105216496.42396.58
31076399-107639998.64498.80
41091541-1091541100.032100.19
51074547-107454798.47498.63
61050409-105040996.26296.42
15min11061147-106114797.24698.651.6097.5698.971.60
21058802-105880297.03197.35
31087786-108778699.687100.01
41100175-1100175100.823101.15
51086020-108602099.52699.85
61064770-106477097.57897.89
20min11063877-106387797.49699.001.6797.9799.491.67
21060966-106096697.23097.71
31095867-1095867100.428100.92
41103291-1103291101.108101.60
51089007-108900799.799100.29
61068953-106895397.96298.44
30min11066481-106648197.73599.161.6998.3799.811.69
21060107-106010797.15197.79
31094778-1094778100.328100.98
41105867-1105867101.344102.01
51092497-1092497100.119100.77
61072385-107238598.27698.92
45min11064288-106428897.53498.941.7598.3499.761.75
21056856-105685696.85397.66
31092009-1092009100.074100.90
41104814-1104814101.248102.08
51090684-109068499.953100.77
61069218-106921897.98698.79
极限11062341-106234197.35698.761.6898.3299.741.67
21055751-105575196.75297.72
31089983-108998399.889100.88
41100909-1100909100.890101.89
51088742-108874299.775100.76
61068066-106806697.88098.85
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%
117.279518819514959511629510879510729513390.04
217.239516249517289516760.01
单位质量响应值RSD%判断
55086.2255233.660.19数据可信
供试品溶液-2024052011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%
5min1992287-99228791.08891.942.6591.0991.942.64
21003119-100311992.08292.08
31011003-101100392.80692.81
4954160-95416087.58887.59
51021882-102188293.80593.80
61027228-102722894.29694.30
10min11054306-105430696.78198.231.2796.9398.381.26
21066251-106625197.87898.03
31059289-105928997.23997.39
41085001-108500199.59999.74
51087537-108753799.83299.99
61068090-106809098.04798.20
15min11075211-107521198.70098.861.7499.0199.181.74
21048961-104896196.29196.61
31064645-106464597.73098.05
41093996-1093996100.425100.74
51099639-1099639100.943101.27
61079398-107939899.08599.41
20min11077750-107775098.93399.661.1099.41100.141.10
21077383-107738398.90099.38
31073067-107306798.50398.98
41098160-1098160100.807101.29
51101765-1101765101.138101.63
61085794-108579499.672100.16
30min11080844-108084499.21799.901.2199.86100.541.20
21076655-107665598.83399.47
31075839-107583998.75899.40
41097974-1097974100.790101.44
51108576-1108576101.763102.42
61089628-1089628100.024100.68
45min11080246-108024699.16299.611.8499.97100.421.83
21075649-107564998.74099.55
31053426-105342696.70097.51
41102832-1102832101.236102.05
51108134-1108134101.722102.55
61090468-1090468100.101100.92
极限11078709-107870999.02199.220.6699.99100.200.67
21073652-107365298.55799.53
31073263-107326398.52199.49
41081267-108126799.256100.24
51089952-1089952100.053101.05
61088356-108835699.907100.89
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%
117.279540419540159537549543819535939539570.04
217.239535219532449533820.03
单位质量响应值RSD%判断
55237.8155332.680.13数据可信
供试品溶液-2024052011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%
5min1968238-96823888.67991.414.0088.6891.414.00
2929908-92990885.16885.17
31024417-102441793.82493.82
41022648-102264893.66293.66
51023340-102334093.72693.73
61019896-101989693.41093.41
10min11073194-107319498.29298.040.8298.4498.200.81
21078663-107866398.79398.93
31075545-107554598.50798.66
41076601-107660198.60498.76
51058821-105882196.97597.13
61060157-106015797.09897.25
15min11083603-108360399.24599.210.8699.5699.530.85
21091550-109155099.973100.28
31089973-108997399.828100.15
41090350-109035099.863100.18
51073926-107392698.35998.68
61070044-107004498.00398.32
20min11091269-109126999.94799.581.09100.42100.061.08
21096567-1096567100.432100.91
31092627-1092627100.072100.56
41096913-1096913100.464100.95
51067502-106750297.77098.25
61078601-107860198.78799.27
30min11093233-1093233100.12799.501.56100.77100.151.55
21054765-105476596.60497.24
31097959-1097959100.560101.21
41101891-1101891100.920101.57
51085657-108565799.433100.08
61084871-108487199.361100.01
45min11087482-108748299.60099.940.85100.41100.750.84
21095186-1095186100.306101.11
31097406-1097406100.509101.33
41103823-1103823101.097101.92
51083613-108361399.246100.06
61079555-107955598.87499.69
极限11093587-1093587100.15999.990.71101.14100.970.70
21094968-1094968100.286101.25
31095450-1095450100.330101.32
41101243-1101243100.861101.85
51084009-108400999.282100.26
61080953-108095399.00299.98
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