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%
117.609287599285739283569294759284489287220.05
217.639288839299959294390.09
单位质量响应值RSD%判断
52768.3052719.170.07数据可信
供试品溶液-2024051711批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1591345-59134556.77053.004.2256.7753.004.22
2553572-55357253.14453.14
3526303-52630350.52650.53
4539290-53929051.77251.77
5563785-56378554.12454.12
6537997-53799751.64851.65
10min1592023-59202356.83552.1410.4256.9352.2310.41
2558769-55876953.64253.73
3431194-43119441.39541.48
4552717-55271753.06153.15
5566212-56621254.35754.45
6557628-55762853.53353.62
15min1589904-58990456.63153.563.1756.8253.733.18
2556576-55657653.43253.61
3539571-53957151.79951.95
4549350-54935052.73852.91
5563569-56356954.10354.28
6548469-54846952.65452.83
20min1573616-57361655.06852.882.5655.3553.142.57
2548441-54844152.65152.92
3536172-53617251.47351.71
4539755-53975551.81752.08
5561057-56105753.86254.13
6545868-54586852.40452.67
30min1572790-57279054.98952.142.9355.3652.492.93
2541998-54199852.03252.39
3528352-52835250.72251.05
4532562-53256251.12751.48
5546266-54626652.44252.80
6536605-53660551.51551.87
45min1557080-55708053.48050.883.1853.9551.323.18
2528557-52855750.74251.18
3519908-51990849.91250.32
4523357-52335750.24350.68
5541354-54135451.97152.42
6509929-50992948.95449.39
极限1518826-51882649.80847.752.4050.3648.282.41
2497100-49710047.72248.25
3487319-48731946.78347.28
4487484-48748446.79947.32
5501874-50187448.18148.72
6491951-49195147.22847.75
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%
117.609301789299829298779297879298549299360.02
217.639299179304439301800.04
单位质量响应值RSD%判断
52837.2752761.200.11数据可信
供试品溶液-t2批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1567182-56718254.39347.2914.2154.3947.2914.20
2528626-52862650.69550.70
3424160-42416040.67740.68
4491474-49147447.13347.13
5551808-55180852.91952.92
6395310-39531037.91037.91
10min1579735-57973555.59750.509.4755.6950.589.48
2529534-52953450.78250.87
3450954-45095443.24743.31
4517005-51700549.58149.66
5582261-58226155.83955.93
6500357-50035747.98448.05
15min1575679-57567955.20850.628.9155.3950.788.91
2533360-53336051.14951.32
3454812-45481243.61743.76
4519078-51907849.78049.94
5580194-58019455.64155.82
6503856-50385648.32048.46
20min1571231-57123154.78150.388.3655.0650.638.37
2525921-52592150.43650.69
3455964-45596443.72743.94
4521733-52173350.03450.28
5572851-57285154.93755.21
6504246-50424648.35748.58
30min1561016-56101653.80248.9510.4054.1749.2810.39
2524007-52400750.25250.59
3451481-45148143.29743.58
4516058-51605849.49049.82
5567450-56745054.41954.78
6442784-44278442.46342.77
45min1553077-55307753.04049.067.8053.5049.477.82
2515875-51587549.47349.89
3450224-45022443.17743.53
4505279-50527948.45648.87
5555407-55540753.26453.72
6489363-48936346.93047.31
极限1513948-51394849.28846.246.8249.8346.736.84
2486727-48672746.67747.18
3431165-43116541.34941.78
4477724-47772445.81446.30
5519703-51970349.84050.38
6463753-46375344.47444.93
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%
117.609303879300689290149299379290069296820.07
217.639305729302119303920.03
单位质量响应值RSD%判断
52822.8452773.230.07数据可信
供试品溶液-2024051712批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1603100-60310057.83950.189.8457.8450.189.84
2464510-46451044.54844.55
3534015-53401551.21351.21
4552438-55243852.98052.98
5509865-50986548.89748.90
6475541-47554145.60645.61
10min1547328-54732852.49051.215.0252.5951.305.02
2555344-55534453.25953.33
3540395-54039551.82551.91
4557332-55733253.45053.54
5514196-51419649.31349.39
6489528-48952846.94747.02
15min1581036-58103655.72351.665.7955.9151.835.79
2546754-54675452.43552.60
3551034-55103452.84653.02
4547259-54725952.48352.66
5513960-51396049.29049.45
6492180-49218047.20147.36
20min1581056-58105655.72551.396.4156.0051.646.41
2546083-54608352.37152.62
3538797-53879751.67251.93
4555344-55534453.25953.52
5509050-50905048.81949.06
6484563-48456346.47146.70
30min1581732-58173255.79050.916.1456.1651.256.14
2536276-53627651.43051.77
3529502-52950250.78151.13
4545014-54501452.26852.62
5502432-50243248.18448.51
6489894-48989446.98247.29
45min1570221-57022154.68649.616.4655.1550.036.46
2508366-50836648.75449.18
3520959-52095949.96150.39
4536537-53653751.45551.90
5489510-48951046.94547.35
6478006-47800645.84246.23
极限1533750-53375051.18846.816.2051.7447.326.20
2501486-50148648.09448.60
3487532-48753246.75647.27
4496165-49616547.58348.11
5460101-46010144.12544.61
6449812-44981243.13843.60
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