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%
117.579582439604609594649590059592129592770.09
217.529588489588889588680.01
单位质量响应值RSD%判断
54597.4454729.910.18数据可信
加速6月-供试品溶液-2024051911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%
5min1964369-96436989.32990.802.7189.3390.802.71
2964816-96481689.37089.37
3967502-96750289.61989.62
4983880-98388091.13691.14
5968591-96859189.72089.72
61032410-103241095.63295.63
10min11031349-103134995.53396.591.7595.6896.741.75
21033675-103367595.74995.90
31030275-103027595.43495.58
41057000-105700097.90998.06
51030585-103058595.46395.61
61073475-107347599.43599.59
15min11054437-105443797.67298.550.9897.9898.860.98
21059982-105998298.18698.49
31058100-105810098.01198.32
41072836-107283699.37699.69
51057697-105769797.97498.28
61080522-1080522100.088100.41
20min11064650-106465098.61899.450.6099.0999.930.61
21071857-107185799.28699.76
31075830-107583099.654100.13
41077267-107726799.787100.27
51069380-106938099.05699.53
61082943-1082943100.312100.80
30min11074896-107489699.567100.360.52100.20101.000.52
21083006-1083006100.318100.96
31090939-1090939101.053101.69
41081934-1081934100.219100.87
51081916-1081916100.217100.85
61088151-1088151100.795101.45
45min11075538-107553899.627100.390.60100.43101.200.60
21082305-1082305100.253101.06
31093543-1093543101.294102.10
41080202-1080202100.059100.87
51081892-1081892100.215101.02
61089122-1089122100.885101.71
极限11075299-107529999.604100.310.70100.57101.280.70
21079446-107944699.989100.96
31090838-1090838101.044102.02
41078363-107836399.888100.87
51079616-1079616100.004100.98
61093721-1093721101.311102.31
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%
117.579577399588519590869590969592419588030.07
217.529583389592259587820.07
单位质量响应值RSD%判断
54570.4654725.000.20数据可信
加速6月-供试品溶液-2024052011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%
5min1963148-96314889.24289.801.7189.2489.801.71
2969067-96906789.79089.79
3973290-97329090.18290.18
4983018-98301891.08391.08
5985965-98596591.35691.36
6940347-94034787.12987.13
10min11050238-105023897.31196.311.8497.4696.461.84
21039135-103913596.28396.43
31060235-106023598.23898.39
41033231-103323195.73695.89
51048190-104819097.12297.27
61005449-100544993.16193.31
15min11072703-107270399.39398.361.7999.7098.671.79
21061592-106159298.36398.67
31083825-1083825100.423100.74
41051924-105192497.46897.78
51069651-106965199.11099.42
61029707-102970795.40995.71
20min11085263-1085263100.55799.461.72101.0399.931.72
21074749-107474999.583100.06
31092509-1092509101.228101.71
41062480-106248098.44698.92
51083100-1083100100.356100.84
61042207-104220796.56797.03
30min11097286-1097286101.671100.661.52102.31101.301.52
21092345-1092345101.213101.85
31102628-1102628102.166102.82
41072649-107264999.388100.03
51093408-1093408101.311101.96
61060078-106007898.22398.84
45min11101163-1101163102.030100.901.46102.84101.701.46
21097421-1097421101.683102.49
31102285-1102285102.134102.95
41073522-107352299.469100.27
51094657-1094657101.427102.24
61064656-106465698.64799.43
极限11100425-1100425101.962100.651.58102.95101.631.58
21096464-1096464101.595102.57
31099735-1099735101.898102.89
41067623-106762398.92299.89
51091827-1091827101.165102.15
61061725-106172598.37699.32
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%
117.579587509582439585979584409590819586220.04
217.529596229596059596140.01
单位质量响应值RSD%判断
54560.1654772.490.28数据可信
加速6月-供试品溶液-2024052111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%
5min1995546-99554692.21390.851.9692.2190.851.96
2987905-98790591.50591.50
3995563-99556392.21492.21
4979728-97972890.74890.75
5944048-94404887.44387.44
6982360-98236090.99190.99
10min11036793-103679396.03395.971.7096.1996.121.70
21036457-103645796.00296.15
31050148-105014897.27097.42
41049600-104960097.21997.37
51002464-100246492.85393.00
61041410-104141096.46196.61
15min11050777-105077797.32898.041.4797.6498.351.47
21060573-106057398.23698.55
31068431-106843198.96499.28
41075628-107562899.63099.94
51031808-103180895.57195.87
61063741-106374198.52998.84
20min11059259-105925998.11499.081.1198.5999.551.10
21075718-107571899.639100.11
31075981-107598199.663100.14
41082880-1082880100.302100.78
51051616-105161697.40697.87
61072364-107236499.32899.80
30min11074474-107447499.523100.230.65100.16100.870.65
21091917-1091917101.139101.78
31086198-1086198100.609101.26
41083917-1083917100.398101.04
51073971-107397199.477100.10
61082016-1082016100.222100.86
45min11079236-107923699.964100.480.57100.77101.280.57
21096490-1096490101.563102.37
31085730-1085730100.566101.38
41082942-1082942100.308101.12
51081021-1081021100.130100.92
61083094-1083094100.322101.13
极限11076985-107698599.756100.240.58100.73101.210.59
21094252-1094252101.355102.34
31083121-1083121100.324101.31
41078888-107888899.932100.91
51078805-107880599.925100.88
61081104-1081104100.137101.11
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%
117.579583389575489587009583529581449582160.05
217.529597459593569595500.03
单位质量响应值RSD%判断
54537.0554768.840.30数据可信
长期6月-供试品溶液-2024051911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%
5min11001778-100177892.81392.661.1792.8192.661.17
2999128-99912892.56792.57
31017499-101749994.26994.27
41005585-100558593.16593.17
5982557-98255791.03291.03
6994466-99446692.13592.14
10min11056016-105601697.83897.390.8997.9997.550.89
21054867-105486797.73197.89
31063676-106367698.54798.70
41052167-105216797.48197.64
51039062-103906296.26796.42
61041625-104162596.50496.66
15min11083457-1083457100.38099.310.80100.7099.630.80
21071082-107108299.23499.55
31079931-1079931100.053100.37
41069441-106944199.08299.40
51067667-106766798.91799.23
61060116-106011698.21898.53
20min11098261-1098261101.752100.380.86102.24100.860.86
21079962-1079962100.056100.54
31090918-1090918101.071101.56
41077821-107782199.858100.34
51080468-1080468100.103100.58
61073434-107343499.45199.93
30min11109138-1109138102.759101.310.86103.41101.960.86
21088803-1088803100.875101.52
31099118-1099118101.831102.49
41085675-1085675100.586101.23
51093188-1093188101.282101.93
61084808-1084808100.505101.15
45min11113244-1113244103.140101.191.05103.97102.001.05
21087803-1087803100.783101.60
31096853-1096853101.621102.45
41083649-1083649100.398101.21
51088217-1088217100.821101.63
61083248-1083248100.361101.17
极限11110402-1110402102.876100.921.04103.87101.911.03
21081440-1081440100.193101.18
31092262-1092262101.196102.19
41082905-1082905100.329101.31
51088405-1088405100.838101.82
61080632-1080632100.118101.10
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