盐酸伐地那非片项目信息
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)5供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.973813293815453815863815253815853815140.03
211.993836243838823837530.05
单位质量响应值RSD%判断
31872.5132006.090.30数据可信
供试品溶液-2024072521批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1203935-20393596.79594.502.4296.7994.502.42
2195987-19598793.02293.02
3204388-20438897.01097.01
4200110-20011094.97994.98
5198342-19834294.14094.14
6191810-19181091.04091.04
10min1209510-20951099.44197.602.4599.6097.762.45
2202066-20206695.90896.06
3211504-211504100.387100.55
4208663-20866399.03999.20
5198494-19849494.21294.37
6203582-20358296.62796.78
15min1210236-21023699.78698.511.94100.1198.831.94
2201861-20186195.81096.13
3211894-211894100.573100.90
4210849-210849100.077100.40
5204744-20474497.17997.49
6205672-20567297.61997.93
20min1210011-21001199.67998.202.68100.1798.692.68
2201653-20165395.71296.19
3211930-211930100.590101.09
4211731-211731100.495100.99
5198681-19868194.30194.78
6207365-20736598.42398.90
30min1209133-20913399.26298.052.8599.9298.702.84
2201199-20119995.49696.13
3211934-211934100.591101.26
4212413-212413100.819101.48
5197958-19795893.95894.59
6206802-20680298.15698.80
45min1208931-20893199.16697.982.9899.9998.802.97
2200435-20043595.13495.93
3211241-211241100.263101.09
4213816-213816101.485102.31
5198187-19818794.06794.86
6206017-20601797.78398.59
60min1208479-20847998.95297.662.7199.9498.642.71
2200545-20054595.18696.14
3211376-211376100.327101.33
4210790-210790100.049101.04
5197771-19777193.86994.82
6205636-20563697.60298.57
极限1208214-20821498.82697.472.8699.9898.612.85
2199807-19980794.83695.95
3210263-21026399.798100.96
4211649-211649100.456101.62
5197035-19703593.52094.62
6205169-20516997.38198.51
盐酸伐地那非片项目信息
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)5供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.973814863818683818483819363820463818370.06
211.993838903836633837760.05
单位质量响应值RSD%判断
31899.5032008.010.25数据可信
供试品溶液-2024072522批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1198661-19866194.24995.351.6394.2595.351.63
2197589-19758993.74093.74
3199190-19919094.50094.50
4206401-20640197.92197.92
5202927-20292796.27396.27
6201124-20112495.41795.42
10min1206138-20613897.79698.030.6197.9598.190.61
2205661-20566197.57097.73
3205588-20558897.53597.69
4208959-20895999.13499.30
5206935-20693598.17498.33
6206489-20648997.96398.12
15min1206875-20687598.14698.520.5998.4798.840.59
2206434-20643497.93798.26
3207589-20758998.48498.80
4209945-20994599.60299.93
5207363-20736398.37798.70
6207755-20775598.56398.89
20min1206843-20684398.13198.550.5898.6199.040.58
2206610-20661098.02098.50
3207876-20787698.62199.10
4209839-20983999.552100.05
5207103-20710398.25498.74
6208086-20808698.72099.21
30min1206880-20688098.14898.660.8898.8099.310.88
2206257-20625797.85398.50
3207359-20735998.37599.02
4211377-211377100.282100.94
5207378-20737898.38499.04
6208479-20847998.90799.56
45min1206254-20625497.85198.711.1198.6699.521.11
2205757-20575797.61598.42
3206648-20664898.03898.85
4210171-21017199.709100.54
5211440-211440100.311101.13
6208079-20807998.71799.53
60min1205867-20586797.66898.360.9298.6499.340.92
2205444-20544497.46798.44
3206361-20636197.90298.88
4210456-21045699.845100.84
5207244-20724498.32199.30
6208603-20860398.96699.95
极限1205621-20562197.55198.340.9998.6999.480.98
2204698-20469897.11398.25
3208800-20880099.059100.20
4210283-21028399.763100.92
5207077-20707798.24299.39
6207181-20718198.29199.44
盐酸伐地那非片项目信息
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)5供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.973827713819793832353827973828653827290.12
211.993821693820023820860.04
单位质量响应值RSD%判断
31974.0231867.060.24数据可信
供试品溶液-2024072621批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1205396-20539697.54595.783.1097.5595.783.10
2207012-20701298.31398.31
3203038-20303896.42696.43
4192861-19286191.59291.59
5194908-19490892.56592.56
6206833-20683398.22898.23
10min1209772-20977299.62498.562.9099.7998.732.90
2214127-214127101.692101.86
3206601-20660198.11898.28
4203285-20328596.54396.70
5198439-19843994.24294.40
6213020-213020101.166101.33
15min1209836-20983699.65499.513.7699.9899.843.76
2214560-214560101.898102.23
3207628-20762898.60598.93
4203928-20392896.84897.16
5199518-19951894.75495.07
6221749-221749105.312105.64
20min1209599-20959999.54299.042.58100.0499.542.58
2214410-214410101.826102.33
3208020-20802098.79299.28
4204381-20438197.06397.54
5200799-20079995.36295.83
6214101-214101101.680102.19
30min1209667-20966799.57499.592.73100.23100.252.73
2213686-213686101.483102.16
3207395-20739598.49599.15
4213882-213882101.576102.21
5199453-19945394.72395.35
6214173-214173101.714102.39
45min1208973-20897399.24498.562.72100.0799.382.72
2212975-212975101.145101.99
3208238-20823898.89599.71
4204108-20410896.93497.74
5198165-19816594.11194.90
6212749-212749101.038101.88
60min1208218-20821898.88698.342.4899.8899.332.49
2212668-212668100.999102.01
3207636-20763698.60999.59
4203245-20324596.52497.49
5199085-19908594.54895.49
6211581-211581100.483101.50
极限1208558-20855899.04797.942.67100.2099.092.67
2211810-211810100.592101.77
3205310-20531097.50598.65
4202300-20230096.07597.20
5197837-19783793.95695.06
6211540-211540100.463101.65
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