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%
117.412438092434692435372433952436422435700.07
217.42438192438012438100.01
单位质量响应值RSD%判断
13990.2414012.070.12数据可信
长期30℃12月-供试品溶液-2023052611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%
5min1113010-11301040.87041.732.5940.8741.732.58
2118526-11852642.86442.86
3110793-11079340.06840.07
4115407-11540741.73741.74
5117840-11784042.61642.62
6116728-11672842.21442.21
10min1122497-12249744.30144.721.8844.3744.791.88
2125630-12563045.43445.51
3119568-11956843.24143.31
4123733-12373344.74844.82
5125275-12527545.30545.38
6125173-12517345.26845.34
15min1126660-12666045.80646.321.7745.9546.461.77
2130859-13085947.32547.47
3124519-12451945.03245.17
4128052-12805246.31046.45
5129766-12976646.92947.08
6128631-12863146.51946.66
20min1129775-12977546.93348.264.0147.1548.483.99
2133440-13344048.25848.48
3129041-12904146.66746.88
4143733-14373351.98052.20
5133274-13327448.19848.42
6131447-13144747.53747.76
30min1134487-13448748.63750.032.3648.9350.332.34
2139907-13990750.59750.90
3143464-14346451.88352.17
4137444-13744449.70650.01
5139240-13924050.35650.66
6135532-13553249.01549.32
45min1139776-13977650.54951.641.4450.9352.031.44
2145371-14537152.57352.96
3142074-14207451.38151.76
4143888-14388852.03752.43
5144163-14416352.13652.53
6141541-14154151.18851.57
极限1159557-15955757.70358.561.0758.1759.041.07
2163411-16341159.09759.58
3161201-16120158.29858.76
4162749-16274958.85859.34
5163988-16398859.30659.78
6160707-16070758.11958.59
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%
117.412433832432492433612430582430712432240.07
217.42434092436172435130.07
单位质量响应值RSD%判断
13970.3613995.000.13数据可信
长期30℃12月-供试品溶液-2023052711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%
5min1125740-12574045.53345.742.9345.5345.742.93
2124874-12487445.22045.22
3131990-13199047.79747.80
4127654-12765446.22746.23
5126849-12684945.93545.94
6120707-12070743.71143.71
10min1132872-13287248.11649.174.3248.1949.244.32
2145285-14528552.61152.69
3139703-13970350.59050.67
4134155-13415548.58148.66
5134038-13403848.53848.61
6128587-12858746.56446.64
15min1136131-13613149.29649.682.7049.4549.842.70
2135321-13532149.00349.17
3143882-14388252.10352.27
4137343-13734349.73549.89
5137524-13752449.80149.96
6132870-13287048.11548.27
20min1138827-13882750.27350.912.6250.5151.162.63
2139912-13991250.66550.91
3147486-14748653.40853.66
4139179-13917950.40050.64
5141360-14136051.19051.43
6136835-13683549.55149.78
30min1143351-14335151.91152.662.7152.2352.982.71
2144333-14433352.26652.60
3153096-15309655.44055.78
4144079-14407952.17452.50
5145572-14557252.71553.04
6142069-14206951.44751.76
45min1148839-14883953.89854.923.0054.3155.332.99
2153092-15309255.43855.85
3159702-15970257.83258.26
4148927-14892753.93054.34
5152200-15220055.11555.53
6147147-14714753.28553.68
极限1166327-16632760.23160.772.1160.7361.282.11
2167549-16754960.67461.18
3174403-17440363.15663.68
4166732-16673260.37860.88
5168031-16803160.84861.35
6163885-16388559.34759.83
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