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%
117.909754929756109747959750049750969751990.04
217.719765879764249765060.02
单位质量响应值RSD%判断
54480.3955138.680.85数据可信
供试品溶液-2022051801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%
5min11055618-105561897.52597.281.0397.5297.281.03
21060593-106059397.98497.98
31033953-103395395.52395.52
41048299-104829996.84896.85
51064362-106436298.33298.33
61054919-105491997.46097.46
10min11069722-106972298.82898.271.0198.9998.431.02
21068778-106877898.74098.90
31044677-104467796.51496.67
41059211-105921197.85698.02
51075177-107517799.33199.50
61064680-106468098.36298.52
15min11068219-106821998.68998.251.0999.0298.581.09
21067425-106742598.61598.94
31043518-104351896.40796.73
41056402-105640297.59797.92
51074694-107469499.28799.62
61070450-107045098.89599.22
20min11064890-106489098.38197.941.0398.8798.441.03
21066569-106656998.53699.03
31042003-104200396.26796.75
41053884-105388497.36497.85
51072578-107257899.09199.59
61061060-106106098.02798.52
30min11082218-108221899.98298.141.38100.6498.791.38
21066204-106620498.50399.16
31039555-103955596.04196.68
41053558-105355897.33497.98
51070129-107012998.86599.53
61061730-106173098.08998.74
45min11061717-106171798.08897.701.0098.9198.511.00
21064433-106443398.33999.16
31039358-103935896.02296.82
41052313-105231397.21998.03
51068739-106873998.73799.56
61058441-105844197.78598.60
极限11061090-106109098.03097.501.0499.0298.481.04
21061510-106151098.06999.05
31035558-103555895.67196.63
41050820-105082097.08198.05
51065985-106598598.48299.47
61057063-105706397.65898.64
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%
117.909773179779479784319773449770159776110.06
217.719772599778549775560.05
单位质量响应值RSD%判断
54615.1455197.970.76数据可信
供试品溶液-2022051801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%
5min11065337-106533798.24897.121.2398.2597.121.22
21057862-105786297.55897.56
31054690-105469097.26697.27
41041753-104175396.07396.07
51033770-103377095.33795.34
61065272-106527298.24298.24
10min11078822-107882299.49198.211.0499.6698.371.04
21066126-106612698.32098.48
31063382-106338298.06798.23
41057894-105789497.56197.72
51048531-104853196.69896.86
61074763-107476399.11799.28
15min11077797-107779799.39798.221.0799.7398.551.06
21066472-106647298.35298.68
31063901-106390198.11598.44
41057269-105726997.50497.83
51048401-104840196.68697.01
61076682-107668299.29499.62
20min11075897-107589799.22298.041.0899.7298.541.08
21064755-106475598.19498.68
31062627-106262797.99898.49
41054310-105431097.23197.72
51046467-104646796.50796.99
61074746-107474699.11599.61
30min11077234-107723499.34598.101.10100.0198.751.11
21066270-106627098.33498.99
31062568-106256897.99298.64
41055418-105541897.33397.98
51046163-104616396.47997.12
61074491-107449199.09299.75
45min11073856-107385699.03397.841.0799.8698.661.07
21062845-106284598.01898.84
31058517-105851797.61998.43
41053550-105355097.16197.97
51044389-104438996.31697.12
61072475-107247598.90699.73
极限11071179-107117998.78697.631.0999.7898.611.09
21061599-106159997.90398.88
31057307-105730797.50798.49
41050522-105052296.88197.85
51041459-104145996.04697.01
61070081-107008198.68599.67
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%
117.909784809780229781669774619770029778260.07
217.719778499797429787960.14
单位质量响应值RSD%判断
54627.1555267.980.83数据可信
供试品溶液-2022051901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%
5min11065076-106507698.15197.171.2798.1597.171.27
21066275-106627598.26198.26
31065203-106520398.16398.16
41035259-103525995.40395.40
51052880-105288097.02797.03
61042159-104215996.03996.04
10min11080028-108002899.52998.431.2599.6998.591.25
21075502-107550299.11299.28
31077166-107716699.26599.43
41045963-104596396.39096.55
51071772-107177298.76898.93
61058128-105812897.51197.67
15min11079182-107918299.45198.510.9699.7898.830.96
21075419-107541999.10499.43
31076261-107626199.18299.51
41058749-105874997.56897.89
51069862-106986298.59298.92
61054140-105414097.14397.47
20min11075281-107528199.09198.141.2199.5998.631.22
21075012-107501299.06799.56
31072508-107250898.83699.33
41044316-104431696.23896.72
51068950-106895098.50899.00
61053868-105386897.11897.60
30min11074006-107400698.97497.921.2699.6398.581.26
21072992-107299298.88099.54
31071976-107197698.78799.45
41041844-104184496.01096.65
51063855-106385598.03898.69
61051072-105107296.86097.51
45min11072979-107297998.87997.731.2999.7098.551.28
21066786-106678698.30899.13
31069650-106965098.57299.40
41038180-103818095.67296.48
51065867-106586798.22499.04
61049592-104959296.72497.53
极限11070469-107046998.64897.491.2799.6498.461.27
21067094-106709498.33799.32
31065336-106533698.17599.16
41035520-103552095.42796.39
51060201-106020197.70298.68
61048519-104851996.62597.59
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%
117.909770169761279763019762729767679764970.04
217.719772029772409772210.01
单位质量响应值RSD%判断
54552.9155179.050.81数据可信
供试品溶液-2022051901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%
5min11039032-103903295.89396.611.1695.8996.611.16
21064957-106495798.28698.29
31035166-103516695.53695.54
41058746-105874697.71397.71
51043601-104360196.31596.31
61039578-103957895.94395.94
10min11050558-105055896.95798.330.8697.1298.490.86
21072212-107221298.95599.12
31068254-106825498.59098.75
41068481-106848198.61198.77
51074416-107441699.15999.32
61058422-105842297.68397.84
15min11050332-105033296.93698.310.8497.2698.640.84
21072120-107212098.94799.28
31068138-106813898.57998.90
41067825-106782598.55098.88
51073991-107399199.11999.45
61059097-105909797.74598.07
20min11045578-104557896.49798.211.0696.9898.691.06
21070519-107051998.79999.29
31075635-107563599.27199.76
41065636-106563698.34898.84
51071005-107100598.84499.33
61056182-105618297.47697.96
30min11047500-104750096.67598.641.9597.3299.291.94
21069997-106999798.75199.41
31065168-106516898.30598.96
41107085-1107085102.174102.83
51069051-106905198.66499.32
61053654-105365497.24397.89
45min11044264-104426496.37697.760.8497.1898.580.84
21065345-106534598.32299.14
31062243-106224398.03598.85
41060735-106073597.89698.72
51068782-106878298.63999.46
61054340-105434097.30698.12
极限11042635-104263596.22697.440.7397.1998.420.73
21061262-106126297.94598.93
31058398-105839897.68098.66
41059038-105903897.73998.73
51062789-106278998.08699.07
61050787-105078796.97897.95
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