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625
标示量(mg)20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%
117.471902191908071895391895661901961900650.28
217.481913181899701906440.50
单位质量响应值RSD%判断
10879.5110906.410.18数据可信
供试品溶液-2022072301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%
5min1215585-215585100.212100.410.74100.21100.410.74
2214504-21450499.71099.71
3216545-216545100.658100.66
4215838-215838100.330100.33
5214741-21474199.82099.82
6218896-218896101.751101.75
10min1216944-216944100.844100.900.96101.01101.070.96
2216023-216023100.416100.58
3216578-216578100.674100.84
4217688-217688101.190101.36
5214473-21447399.69599.86
6220684-220684102.582102.75
15min1216719-216719100.739101.260.48101.07101.590.48
2216647-216647100.706101.04
3218799-218799101.706102.04
4217663-217663101.178101.51
5218048-218048101.357101.69
6219121-219121101.856102.20
20min1217628-217628101.162101.200.81101.66101.700.81
2215672-215672100.253100.75
3217446-217446101.077101.58
4218131-218131101.396101.90
5216541-216541100.657101.16
6220795-220795102.634103.14
30min1216624-216624100.695100.820.66101.37101.500.67
2215160-215160100.015100.68
3217435-217435101.072101.75
4216360-216360100.573101.25
5216369-216369100.577101.25
6219403-219403101.987102.67
45min1215734-215734100.282100.420.41101.12101.260.41
2214855-21485599.873100.71
3216184-216184100.491101.33
4216289-216289100.539101.38
5215586-215586100.213101.05
6217492-217492101.099101.95
极限1216253-216253100.523100.460.62101.53101.460.62
2215449-215449100.149101.15
3217015-217015100.877101.89
4215348-215348100.102101.11
5214419-21441999.670100.67
6218165-218165101.412102.43
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625
标示量(mg)20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%
117.471914991905081899121896391897201902560.41
217.481900911901321901120.02
单位质量响应值RSD%判断
10890.4410875.970.10数据可信
供试品溶液-2022072401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%
5min1219099-219099101.937102.491.24101.94102.491.24
2219108-219108101.941101.94
3225475-225475104.903104.90
4220543-220543102.609102.61
5217651-217651101.263101.26
6219814-219814102.269102.27
10min1224728-224728104.556103.611.26104.73103.781.26
2220282-220282102.487102.66
3227278-227278105.742105.92
4222439-222439103.491103.66
5220586-220586102.629102.80
6220820-220820102.738102.91
15min1220835-220835102.745103.481.43103.09103.821.43
2220758-220758102.709103.05
3228273-228273106.205106.56
4221929-221929103.254103.60
5223339-223339103.910104.25
6219360-219360102.058102.40
20min1220056-220056102.382102.941.42102.90103.461.41
2220624-220624102.646103.16
3227466-227466105.830106.36
4220860-220860102.756103.27
5219262-219262102.013102.53
6219226-219226101.996102.51
30min1220136-220136102.419102.961.36103.11103.651.35
2220707-220707102.685103.37
3226494-226494105.377106.08
4222891-222891103.701104.39
5218047-218047101.447102.13
6219579-219579102.160102.84
45min1219781-219781102.254102.621.46103.11103.481.46
2218254-218254101.544102.40
3226752-226752105.497106.38
4220379-220379102.532103.39
5217919-217919101.388102.24
6220344-220344102.516103.37
极限1219260-219260102.012102.531.69103.04103.561.68
2219371-219371102.063103.09
3227719-227719105.947107.00
4219347-219347102.052103.08
5217113-217113101.013102.03
6219412-219412102.082103.11
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625
标示量(mg)20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%
117.471905601908481902221901071899631903400.19
217.481917781907921912850.37
单位质量响应值RSD%判断
10895.2510943.080.31数据可信
供试品溶液-2022072501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%
5min1211503-21150398.07999.172.1598.0899.172.15
2214108-21410899.28799.29
3209224-20922497.02297.02
4222508-222508103.182103.18
5213715-21371599.10599.10
6212096-21209698.35498.35
10min1217557-217557100.88798.871.59101.0599.041.59
2214920-21492099.66499.83
3210696-21069697.70597.87
4212871-21287198.71498.89
5208165-20816596.53196.70
6215093-21509399.74499.91
15min1214946-21494699.67698.451.36100.0198.781.36
2215041-21504199.720100.05
3210276-21027697.51097.83
4209690-20969097.23897.57
5209125-20912596.97697.30
6214714-21471499.56899.90
20min1216981-216981100.61999.372.21101.1299.872.20
2214699-21469999.561100.06
3210963-21096397.82998.32
4221816-221816102.862103.36
5208426-20842696.65297.14
6212878-21287898.71799.21
30min1217631-217631100.92199.463.68101.59100.113.66
2228758-228758106.081106.74
3208987-20898796.91297.56
4209525-20952597.16297.83
5208044-20804496.47597.12
6213884-21388499.18399.84
45min1216884-216884100.57498.401.88101.4199.231.88
2216261-216261100.286101.13
3211259-21125997.96698.78
4210659-21065997.68898.52
5206063-20606395.55696.37
6212100-21210098.35699.18
极限1217287-217287100.761100.053.82101.76101.043.79
2231389-231389107.301108.31
3212275-21227598.43799.41
4210257-21025797.50198.50
5208895-20889596.87097.84
6214386-21438699.416100.41
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625
标示量(mg)20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%
117.471898301902261893801895861898171897680.17
217.481899521899251899380.02
单位质量响应值RSD%判断
10862.5110866.020.03数据可信
供试品溶液-B514807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%
5min1208325-20832597.09398.892.2797.0998.892.27
2206462-20646296.22596.22
3211579-21157998.61098.61
4219062-219062102.097102.10
5216537-216537100.920100.92
6211147-21114798.40898.41
10min1211275-21127598.46899.661.9698.6399.831.96
2208501-20850197.17597.34
3214241-21424199.850100.01
4218561-218561101.864102.03
5218835-218835101.991102.16
6211632-21163298.63498.80
15min1210735-21073598.21699.622.1498.5499.952.14
2209634-20963497.70398.03
3214036-21403699.755100.09
4219779-219779102.431102.77
5218701-218701101.929102.27
6209558-20955897.66898.00
20min1211294-21129498.47799.892.0598.97100.392.05
2209658-20965897.71498.20
3215226-215226100.309100.81
4220779-220779102.898103.41
5217856-217856101.535102.04
6211136-21113698.40398.89
30min1211776-21177698.70299.571.7799.36100.231.77
2209183-20918397.49398.14
3212948-21294899.24899.91
4218588-218588101.876102.56
5217869-217869101.541102.22
6211418-21141898.53599.19
45min1210181-21018197.95899.702.3498.78100.532.34
2209333-20933397.56398.37
3213500-21350099.505100.33
4219742-219742102.414103.27
5220449-220449102.744103.59
6210301-21030198.01498.83
极限1213157-21315799.34599.892.12100.33100.882.12
2208859-20885997.34298.32
3211827-21182798.72599.72
4219635-219635102.364103.39
5220113-220113102.587103.60
6212323-21232398.95699.94
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