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%
117.579550989550639541449551899553809549750.06
217.529518759504179511460.11
单位质量响应值RSD%判断
54352.5954289.160.09数据可信
长期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%
5min11024564-102456495.50491.092.6395.5091.092.63
2975417-97541790.92290.92
3973520-97352090.74690.75
4964793-96479389.93289.93
5977354-97735491.10391.10
6947562-94756288.32688.33
10min11055488-105548898.38697.231.8098.5597.381.80
21032210-103221096.21696.37
31026917-102691795.72395.87
41074653-1074653100.173100.32
51028036-102803695.82795.98
61041350-104135097.06897.22
15min11068881-106888199.63599.211.4599.9699.521.44
21061916-106191698.98599.30
31050806-105080697.95098.26
41092164-1092164101.805102.12
51050943-105094397.96398.27
61060953-106095398.89699.20
20min11077884-1077884100.474100.201.36100.96100.681.36
21079423-1079423100.617101.09
31062062-106206298.99999.47
41100803-1100803102.610103.10
51064180-106418099.19699.67
61065555-106555599.32599.80
30min11083479-1083479100.995100.881.31101.65101.531.31
21092452-1092452101.832102.48
31070411-107041199.777100.42
41104815-1104815102.984103.64
51072640-107264099.985100.63
61069887-106988799.728100.37
45min11083352-1083352100.984100.921.24101.81101.741.24
21091396-1091396101.733102.55
31071723-107172399.900100.70
41104620-1104620102.966103.80
51074252-1074252100.135100.94
61070712-107071299.805100.61
极限11079381-1079381100.613100.541.22101.61101.521.22
21086193-1086193101.248102.23
31067802-106780299.534100.51
41100705-1100705102.601103.60
51070493-107049399.785100.76
61066947-106694799.454100.43
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%
117.579592209576199584709569219561659576790.13
217.529533319519369526340.11
单位质量响应值RSD%判断
54506.4954374.090.18数据可信
长期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%
5min11002505-100250593.24393.241.2893.2493.241.28
21000915-100091593.09593.09
3980374-98037491.18491.18
41001517-100151793.15193.15
51017633-101763394.65094.65
61012084-101208494.13494.13
10min11043671-104367197.07198.180.9497.2398.340.94
21047835-104783597.45997.61
31055531-105553198.17498.33
41053290-105329097.96698.12
51070717-107071799.58799.74
61062567-106256798.82998.99
15min11061322-106132298.71399.890.8599.03100.200.85
21065314-106531499.08499.40
31075280-1075280100.011100.33
41076678-1076678100.141100.46
51079385-1079385100.393100.72
61085614-1085614100.972101.29
20min11069937-106993799.514100.680.89100.00101.170.89
21074535-107453599.942100.42
31084955-1084955100.911101.39
41088583-1088583101.249101.73
51080610-1080610100.507101.00
61096335-1096335101.970102.46
30min11080619-1080619100.508101.330.86101.16101.980.86
21082855-1082855100.716101.37
31088917-1088917101.280101.93
41098278-1098278102.150102.80
51082725-1082725100.704101.36
61103385-1103385102.625103.29
45min11080204-1080204100.469101.460.83101.28102.280.82
21086538-1086538101.058101.88
31089544-1089544101.338102.16
41098640-1098640102.184103.01
51085874-1085874100.997101.82
61104302-1104302102.711103.54
极限11078875-1078875100.346101.140.85101.33102.130.84
21080836-1080836100.528101.51
31086791-1086791101.082102.07
41096419-1096419101.977102.97
51080676-1080676100.513101.51
61100646-1100646102.371103.37
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