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%
117.249579249574559576419570489577119575560.04
217.249571619570339570970.01
单位质量响应值RSD%判断
55542.6955516.070.04数据可信
供试品溶液-8184807批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11104013-1104013100.670100.510.92100.67100.510.92
21096253-109625399.96299.96
31120534-1120534102.176102.18
41104388-1104388100.704100.70
51095979-109597999.93799.94
61092629-109262999.63299.63
10min11112081-1112081101.405100.750.91101.57100.920.91
21098902-1098902100.204100.37
31121218-1121218102.239102.41
41104690-1104690100.731100.90
51095047-109504799.852100.02
61097603-1097603100.085100.25
15min11112455-1112455101.439101.050.96101.78101.390.96
21117279-1117279101.879102.21
31118885-1118885102.026102.37
41110255-1110255101.239101.57
51093166-109316699.681100.01
61097300-1097300100.058100.39
20min11110173-1110173101.231100.580.87101.74101.090.87
21095128-109512899.860100.36
31115628-1115628101.729102.24
41101565-1101565100.446100.95
51089850-108985099.37899.88
61106012-1106012100.852101.35
30min11108948-1108948101.120100.370.85101.79101.040.85
21094087-109408799.765100.43
31113812-1113812101.563102.24
41100114-1100114100.314100.99
51088627-108862799.26799.93
61098918-1098918100.205100.87
45min11110237-1110237101.237100.260.92102.08101.090.92
21092186-109218699.591100.43
31113058-1113058101.494102.34
41097552-1097552100.081100.92
51087488-108748899.16399.99
61096279-109627999.964100.80
极限11105909-1105909100.843100.170.89101.85101.170.88
21091128-109112899.495100.50
31110194-1110194101.233102.25
41097141-1097141100.043101.05
51084192-108419298.86299.86
61102417-1102417100.524101.53
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%
117.249566199565979561269567319558659563880.04
217.249588519594639591570.05
单位质量响应值RSD%判断
55474.9455635.560.21数据可信
供试品溶液-8184807批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11105106-1105106100.72397.254.87100.7297.244.87
21053082-105308295.98195.98
3967394-96739488.17188.17
41093572-109357299.67199.67
51089820-108982099.32999.33
61092760-109276099.59799.60
10min11109016-1109016101.07999.651.62101.2599.811.62
21059688-105968896.58396.74
31101241-1101241100.370100.52
41103970-1103970100.619100.79
51092933-109293399.61399.78
61092927-109292799.61399.78
15min11109292-1109292101.10499.671.66101.44100.001.66
21059942-105994296.60696.93
31103177-1103177100.547100.86
41106384-1106384100.839101.17
51090791-109079199.41899.75
61091607-109160799.49299.82
20min11107938-1107938100.98199.231.70101.4999.721.70
21055898-105589896.23896.72
31084233-108423398.82099.30
41103966-1103966100.619101.12
51089676-108967699.31699.81
61090757-109075799.41599.91
30min11104021-1104021100.62499.311.76101.3099.971.76
21054472-105447296.10896.75
31103581-1103581100.584101.23
41102768-1102768100.510101.18
51084573-108457398.85199.51
61088109-108810999.17399.84
45min11101725-1101725100.41599.271.75101.26100.101.75
21052616-105261695.93996.74
31097885-1097885100.065100.88
41099536-1099536100.215101.05
51099319-1099319100.195101.02
61084177-108417798.81599.64
极限11099973-1099973100.25598.841.74101.2699.821.74
21049459-104945995.65196.61
31095632-109563299.859100.84
41097354-1097354100.016101.02
51080944-108094498.52099.51
61083047-108304798.71299.71
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%
117.249570079568949576189569509567629570460.04
217.249629359584579606960.33
单位质量响应值RSD%判断
55513.1155724.830.27数据可信
供试品溶液-8184807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%
5min11024253-102425393.24792.417.0993.2592.417.09
21029637-102963793.73793.74
31074659-107465997.83697.84
41050013-105001395.59295.59
51038990-103899094.58894.59
6872792-87279279.45879.46
10min11039408-103940894.62696.672.5794.7896.822.57
21048971-104897195.49795.65
31096248-109624899.80199.96
41087533-108753399.00899.17
51070339-107033997.44297.60
61028457-102845793.62993.76
15min11044476-104447695.08897.532.4395.4097.842.43
21058548-105854896.36996.68
31102145-1102145100.338100.67
41097976-109797699.958100.28
51080434-108043498.36198.68
61044150-104415095.05895.35
20min11047007-104700795.31897.962.5895.7998.442.58
21063251-106325196.79797.27
31108512-1108512100.917101.41
41104867-1104867100.586101.08
51085780-108578098.84899.33
61046983-104698395.31695.76
30min11051334-105133495.71298.412.6596.3499.052.66
21070312-107031297.44098.08
31111548-1111548101.194101.86
41112487-1112487101.279101.94
51091834-109183499.399100.05
61048437-104843795.44896.05
45min11054771-105477196.02598.632.7196.8199.442.71
21071254-107125497.52698.33
31113959-1113959101.413102.25
41117259-1117259101.714102.54
51093417-109341799.543100.36
61049572-104957295.55296.32
极限11071740-107174097.57099.192.5398.52100.162.54
21076309-107630997.98698.95
31120433-1120433102.003103.01
41121379-1121379102.089103.09
51093958-109395899.593100.57
61053242-105324295.88696.81
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%
117.249562439558239558519556839558049558810.03
217.249610749611879611300.01
单位质量响应值RSD%判断
55445.5355750.000.39数据可信
供试品溶液-8184807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%
5min11004276-100427691.46388.397.4891.4688.397.48
2977631-97763189.03789.04
3827260-82726075.34275.34
41021228-102122893.00793.01
5977589-97758989.03389.03
61015381-101538192.47592.47
10min11031917-103191793.98194.111.7894.1394.251.78
21029340-102934093.74693.89
31048460-104846095.48795.61
41054509-105450996.03896.19
51001858-100185891.24391.39
61033800-103380094.15294.31
15min11053767-105376795.97195.031.9896.2895.341.97
21034700-103470094.23494.54
31053938-105393895.98696.27
41066601-106660197.13997.45
51007505-100750591.75792.06
61044379-104437995.11695.43
20min11050694-105069495.69195.472.1796.1695.932.16
21037446-103744694.48494.95
31053880-105388095.98196.43
41083043-108304398.63799.11
51013657-101365792.31892.77
61050950-105095095.71496.18
30min11058977-105897796.44595.651.7797.0796.261.77
21039220-103922094.64695.26
31055389-105538996.11896.72
41071204-107120497.55998.20
51018600-101860092.76893.37
61057879-105787996.34596.97
45min11063430-106343096.85195.781.9797.6496.561.97
21041097-104109794.81795.59
31054017-105401795.99396.76
41075477-107547797.94898.75
51016254-101625492.55493.32
61059965-105996596.53597.32
极限11062426-106242696.75996.712.0497.7197.652.03
21071291-107129197.56798.50
31079209-107920998.28899.21
41076335-107633598.02698.99
51020217-102021792.91593.83
61061918-106191896.71397.66
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