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%
117.364738744739754740854738164737784739060.03
217.314735654743294739470.12
单位质量响应值RSD%判断
27298.7327379.950.22数据可信
供试品溶液-2024051711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%
5min1537179-53717999.49097.542.6399.4997.542.63
2514247-51424795.24395.24
3513211-51321195.05195.05
4515028-51502895.38795.39
5537803-53780399.60699.61
6542522-542522100.480100.48
10min1542585-542585100.49199.072.13100.6699.242.13
2522047-52204796.68796.85
3529635-52963598.09398.25
4523338-52333896.92797.09
5543065-543065100.580100.75
6548841-548841101.650101.82
15min1542324-542324100.44398.722.73100.7899.052.73
2511255-51125594.68995.01
3531447-53144798.42898.75
4521366-52136696.56196.88
5542581-542581100.490100.82
6549268-549268101.729102.07
20min1541532-541532100.29698.972.07100.8099.462.07
2523891-52389197.02997.51
3529316-52931698.03498.52
4521861-52186196.65397.13
5539832-53983299.981100.48
6549761-549761101.820102.33
30min1542976-542976100.56499.151.96101.2399.811.96
2527107-52710797.62598.26
3529094-52909497.99398.64
4523284-52328496.91797.56
5539518-53951899.923100.59
6550135-550135101.890102.57
45min1540998-540998100.19799.231.91101.03100.051.91
2527272-52727297.65598.46
3529929-52992998.14798.96
4524963-52496397.22798.03
5539494-53949499.919100.75
6551841-551841102.206103.05
极限1540989-540989100.19699.691.81101.20100.681.82
2529384-52938498.04699.01
3536582-53658299.379100.36
4528671-52867197.91498.88
5538679-53867999.768100.77
6555372-555372102.859103.88
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%
117.364730824732354737554732264727884732170.08
217.314742324727974735140.22
单位质量响应值RSD%判断
27259.0427354.940.25数据可信
供试品溶液-2024051711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%
5min1514973-51497395.49097.742.0695.4997.742.06
2537451-53745199.65899.66
3524595-52459597.27597.27
4521440-52144096.68996.69
5543106-543106100.707100.71
6521087-52108796.62496.62
10min1532925-53292598.81999.781.6698.9899.951.66
2548004-548004101.615101.78
3535657-53565799.32699.49
4529876-52987698.25498.41
5550597-550597102.096102.26
6531724-53172498.59698.76
15min1534306-53430699.075100.011.8599.40100.341.85
2550013-550013101.988102.32
3537677-53767799.700100.03
4528763-52876398.04798.37
5553035-553035102.548102.89
6532138-53213898.67399.00
20min1535776-53577699.348100.121.7999.84100.621.79
2550754-550754102.125102.63
3537618-53761899.689100.18
4528992-52899298.09098.58
5552810-552810102.506103.02
6533666-53366698.95799.45
30min1534811-53481199.169100.031.8199.82100.691.81
2549141-549141101.826102.50
3538860-53886099.920100.58
4528553-52855398.00898.66
5553140-553140102.568103.25
6532247-53224798.69399.35
45min1533866-53386698.99499.821.7199.81100.651.71
2547867-547867101.590102.44
3537425-53742599.654100.48
4528487-52848797.99698.81
5551031-551031102.176103.03
6531250-53125098.50999.33
极限1531761-53176198.60399.621.6499.59100.621.64
2547568-547568101.534102.55
3537620-53762099.690100.68
4528208-52820897.94498.92
5548130-548130101.639102.66
6530307-53030798.33499.32
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%
117.364716564732714732224724904729654727210.15
217.314719034723854721440.08
单位质量响应值RSD%判断
27230.4727275.790.12数据可信
供试品溶液-2024051711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%
5min1521929-52192996.97198.401.9696.9798.401.96
2535754-53575499.54099.54
3544920-544920101.243101.24
4528576-52857698.20698.21
5515386-51538695.75695.76
6531113-53111398.67898.68
10min1534475-53447599.302100.471.7999.46100.631.79
2545101-545101101.276101.44
3554152-554152102.958103.13
4541940-541940100.689100.85
5525846-52584697.69997.86
6542910-542910100.869101.03
15min1535570-53557099.506100.661.7499.83100.991.74
2543615-543615101.000101.34
3554815-554815103.081103.42
4545007-545007101.259101.59
5527251-52725197.96098.28
6544342-544342101.135101.47
20min1535037-53503799.407100.471.7599.90100.971.76
2544509-544509101.166101.67
3552716-552716102.691103.20
4543559-543559100.990101.49
5525201-52520197.57998.06
6543558-543558100.990101.49
30min1536779-53677999.730100.521.70100.39101.191.70
2543020-543020100.890101.56
3553422-553422102.822103.51
4543900-543900101.053101.72
5525864-52586497.70298.35
6543174-543174100.918101.59
45min1536914-53691499.755100.491.66100.58101.321.66
2542746-542746100.839101.68
3551638-551638102.491103.35
4545358-545358101.324102.16
5525390-52539097.61498.43
6543132-543132100.911101.75
极限1534928-53492899.386100.341.63100.38101.341.63
2541648-541648100.635101.64
3551674-551674102.498103.52
4544581-544581101.180102.19
5525889-52588997.70798.68
6541528-541528100.613101.62
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