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%
117.619558299558639560409559239576779562660.09
217.639548539548659548590.01
单位质量响应值RSD%判断
54302.4454161.030.19数据可信
中间条件3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%
5min1929844-92984486.81793.263.8686.8293.263.85
21016480-101648094.90694.91
31009821-100982194.28494.28
4998847-99884793.26093.26
51045381-104538197.60497.60
6992450-99245092.66292.66
10min11077629-1077629100.615100.102.20100.76100.262.20
21044962-104496297.56597.72
31055162-105516298.51898.67
41099382-1099382102.646102.80
51099095-1099095102.619102.78
61056635-105663598.65598.81
15min11093550-1093550102.102101.631.72102.41101.961.72
21062118-106211899.16799.49
31091540-1091540101.914102.24
41097132-1097132102.436102.76
51114575-1114575104.065104.40
61072277-1072277100.116100.43
20min11097302-1097302102.452101.841.85102.93102.321.85
21068125-106812599.728100.21
31075759-1075759100.441100.93
41103254-1103254103.008103.51
51121458-1121458104.707105.21
61078307-1078307100.679101.16
30min11097344-1097344102.456102.161.74103.11102.821.74
21073522-1073522100.232100.88
31079159-1079159100.758101.42
41107680-1107680103.421104.09
51123321-1123321104.881105.56
61083717-1083717101.184101.84
45min11097894-1097894102.507102.361.67103.33103.201.67
21074622-1074622100.335101.15
31077808-1077808100.632101.46
41107653-1107653103.419104.26
51123110-1123110104.862105.72
61097055-1097055102.429103.25
极限11094299-1094299102.172102.151.58103.17103.161.58
21083665-1083665101.179102.17
31075899-1075899100.454101.45
41104784-1104784103.151104.16
51122611-1122611104.815105.85
61083312-1083312101.146102.14
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%
117.619542489550889557309546119551519549660.06
217.639567699568889568280.01
单位质量响应值RSD%判断
54228.6254272.720.06数据可信
中间条件3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%
5min1998275-99827593.17493.141.0293.1793.141.02
2995918-99591892.95492.95
3990759-99075992.47292.47
4998582-99858293.20293.20
51016599-101659994.88494.88
6987646-98764692.18192.18
10min11063784-106378499.28898.321.0099.4498.471.00
21060900-106090099.01999.17
31050739-105073998.07098.22
41056677-105667798.62498.78
51053879-105387998.36398.52
61034356-103435696.54196.69
15min11084107-1084107101.18599.770.99101.51100.080.99
21063907-106390799.29999.62
31068055-106805599.686100.00
41074300-1074300100.269100.59
51070328-107032899.899100.22
61052752-105275298.25898.57
20min11092835-1092835101.999101.081.77102.49101.571.76
21070069-107006999.874100.36
31079536-1079536100.758101.24
41083087-1083087101.089101.58
51113856-1113856103.961104.45
61058656-105865698.80999.29
30min11099881-1099881102.657101.001.19103.32101.651.19
21075142-1075142100.348101.00
31086299-1086299101.389102.04
41091210-1091210101.848102.50
51076114-1076114100.439101.10
61064095-106409599.31799.96
45min11103927-1103927103.035101.161.17103.87101.981.17
21077269-1077269100.546101.37
31089051-1089051101.646102.47
41087617-1087617101.512102.34
51077683-1077683100.585101.41
61067346-106734699.620100.43
极限11101038-1101038102.765100.921.12103.77101.911.12
21075236-1075236100.357101.34
31087215-1087215101.475102.46
41082922-1082922101.074102.07
51075044-1075044100.339101.34
61066241-106624199.517100.49
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%
117.619566929558539561089555349560549560480.05
217.639566419562929564660.03
单位质量响应值RSD%判断
54290.0654252.180.05数据可信
中间条件3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%
5min11003618-100361893.63793.901.3393.6493.901.33
21012755-101275594.48994.49
3997919-99791993.10593.11
41025427-102542795.67295.67
51012131-101213194.43194.43
6987043-98704392.09092.09
10min11046554-104655497.64398.421.7197.8098.571.70
21080435-1080435100.804100.96
31061101-106110199.00099.16
41065930-106593099.45199.61
51045352-104535297.53197.69
61029680-102968096.06896.22
15min11063901-106390199.26199.641.6399.5899.961.62
21067924-106792499.63799.96
31072846-1072846100.096100.42
41098544-1098544102.493102.82
51056265-105626598.54998.87
61048308-104830897.80698.12
20min11071769-107176999.99599.901.07100.48100.391.07
21074165-1074165100.219100.71
31077386-1077386100.519101.01
41085874-1085874101.311101.81
51061194-106119499.00999.49
61054193-105419398.35698.83
30min11076052-1076052100.395100.171.05101.05100.831.05
21078119-1078119100.588101.25
31081224-1081224100.878101.53
41086407-1086407101.361102.03
51063105-106310599.18799.84
61056971-105697198.61599.26
45min11075036-1075036100.300100.051.10101.12100.871.10
21076012-1076012100.391101.22
31079355-1079355100.703101.53
41087048-1087048101.421102.25
51061742-106174299.06099.87
61055204-105520498.45099.25
极限11075476-1075476100.34199.971.07101.33100.961.07
21073744-1073744100.180101.17
31079535-1079535100.720101.71
41084533-1084533101.186102.19
51061098-106109899.00099.98
61054675-105467598.40199.37
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