枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.824661384704964697234702654687144690670.38
213.884754024721644737830.49
单位质量响应值RSD%判断
33941.1734134.220.41数据可信
供试品溶液-2024041221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%
2min1244827-24482745.52638.4617.2445.5338.4617.24
2159546-15954629.66829.67
3227671-22767142.33642.34
4239508-23950844.53744.54
5174903-17490332.52432.52
6194581-19458136.18336.18
5min1329256-32925661.22660.025.8161.2360.025.81
2285812-28581253.14753.15
3324161-32416160.27860.28
4338728-33872862.98762.99
5330908-33090861.53361.53
6327729-32772960.94260.94
10min1316688-31668858.88961.085.3658.8961.085.36
2347710-34771064.65764.66
3340412-34041263.30063.30
4327178-32717860.83960.84
5338650-33865062.97362.97
6300356-30035655.85255.85
15min1312415-31241558.09459.674.8058.0959.674.79
2323605-32360560.17560.17
3311641-31164157.95057.95
4321584-32158459.79959.80
5349395-34939564.97164.97
6306622-30662257.01757.02
20min1303821-30382156.49659.162.7856.5059.162.78
2316591-31659158.87158.87
3316607-31660758.87458.87
4326399-32639960.69560.69
5328624-32862461.10861.11
6316963-31696358.94058.94
30min1301549-30154956.07457.041.6956.0757.041.69
2305391-30539156.78856.79
3303580-30358056.45156.45
4312746-31274658.15658.16
5313696-31369658.33258.33
6303557-30355756.44756.45
45min1297723-29772355.36254.732.4055.3654.732.40
2286936-28693653.35653.36
3289990-28999053.92453.92
4287539-28753953.46853.47
5303403-30340356.41856.42
6300274-30027455.83755.84
极限1283053-28305352.63453.181.0252.6353.181.02
2284328-28432852.87152.87
3285672-28567253.12153.12
4287923-28792353.54053.54
5290776-29077654.07054.07
6284077-28407752.82552.82
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.824701974715224719744714034711274712450.15
213.884693864687304690580.10
单位质量响应值RSD%判断
34098.7733793.800.64数据可信
供试品溶液-2024041221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%
2min1184479-18447934.39738.1315.5334.4038.1415.53
2209977-20997739.15139.15
3232735-23273543.39543.39
4205604-20560438.33638.34
5240215-24021544.78944.79
6154121-15412128.73728.74
5min1303527-30352756.59453.054.4856.5953.064.47
2271308-27130850.58750.59
3294586-29458654.92754.93
4279014-27901452.02452.02
5286106-28610653.34653.35
6272722-27272250.85050.85
10min1304902-30490256.85051.636.2256.8551.636.22
2258885-25888548.27048.27
3286963-28696353.50653.51
4278683-27868351.96251.96
5262210-26221048.89048.89
6269769-26976950.30050.30
15min1267058-26705849.79452.224.6249.7952.224.62
2276107-27610751.48251.48
3293002-29300254.63254.63
4299127-29912755.77455.77
5270559-27055950.44750.45
6274628-27462851.20651.21
20min1276652-27665251.58352.262.8151.5852.262.82
2288876-28887653.86253.86
3287202-28720253.55053.55
4285484-28548453.23053.23
5271441-27144150.61250.61
6271918-27191850.70050.70
30min1278213-27821351.87452.752.0651.8752.752.07
2285169-28516953.17153.17
3285560-28556053.24453.24
4292226-29222654.48754.49
5277006-27700651.64951.65
6279193-27919352.05752.06
45min1275781-27578151.42151.582.7951.4251.582.80
2285355-28535553.20653.21
3279754-27975452.16252.16
4276494-27649451.55451.55
5279932-27993252.19552.19
6262502-26250248.94548.94
极限1282570-28257052.68751.514.1752.6951.504.18
2278910-27891052.00452.00
3279665-27966552.14552.14
4280536-28053652.30752.31
5282793-28279352.72852.73
6252939-25293947.16247.16
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.824690744693114710604709214708524702440.21
213.884682604691394687000.14
单位质量响应值RSD%判断
34026.3433768.010.54数据可信
供试品溶液-2024041221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%
2min1430098-43009880.31078.629.4680.3178.629.46
2381972-38197271.32371.32
3494652-49465292.36392.36
4400555-40055574.79374.79
5419607-41960778.35178.35
6399292-39929274.55774.56
5min1540159-540159100.86199.651.91100.8699.651.91
2518706-51870696.85596.85
3547160-547160102.168102.17
4534827-53482799.86599.87
5535573-535573100.004100.00
6525734-52573498.16798.17
10min1545422-545422101.843101.141.05101.84101.141.05
2534777-53477799.85699.86
3549002-549002102.512102.51
4537400-537400100.345100.35
5545334-545334101.827101.83
6538087-538087100.474100.47
15min1544919-544919101.749101.180.89101.75101.180.89
2537408-537408100.347100.35
3549114-549114102.533102.53
4539205-539205100.683100.68
5543353-543353101.457101.46
6537055-537055100.281100.28
20min1544296-544296101.633101.271.18101.63101.261.18
2537870-537870100.433100.43
3550593-550593102.809102.81
4539218-539218100.685100.68
5547970-547970102.319102.32
6534043-53404399.71999.72
30min1545693-545693101.894101.350.96101.89101.350.96
2539825-539825100.798100.80
3548352-548352102.391102.39
4539411-539411100.721100.72
5547699-547699102.269102.27
6535596-535596100.009100.01
45min1543058-543058101.402101.351.27101.40101.351.27
2538974-538974100.639100.64
3553200-553200103.296103.30
4538244-538244100.503100.50
5548195-548195102.361102.36
6534941-53494199.88699.89
极限1548482-548482102.415101.571.14102.41101.571.15
2535997-535997100.084100.08
3552664-552664103.196103.20
4538517-538517100.554100.55
5545216-545216101.805101.80
6543008-543008101.393101.39
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.824720224700704691064688854687564697680.29
213.884712594717634715110.08
单位质量响应值RSD%判断
33991.9033970.530.05数据可信
供试品溶液-2024041221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%
2min1326396-32639660.79474.2017.6160.7974.2017.61
2296256-29625655.18155.18
3467807-46780787.13487.13
4451844-45184484.16084.16
5425570-42557079.26679.27
6422359-42235978.66878.67
5min1499319-49931993.00397.666.3293.0097.666.32
2468938-46893887.34487.34
3554004-554004103.189103.19
4543236-543236101.183101.18
5544396-544396101.399101.40
6536160-53616099.86599.86
10min1545754-545754101.652101.952.06101.65101.952.06
2529357-52935798.59898.60
3562685-562685104.805104.81
4551955-551955102.807102.81
5552191-552191102.851102.85
6542254-542254101.000101.00
15min1549132-549132102.281102.891.62102.28102.891.62
2541591-541591100.877100.88
3565531-565531105.336105.34
4556488-556488103.651103.65
5557110-557110103.767103.77
6544608-544608101.438101.44
20min1550961-550961102.622102.691.59102.62102.701.59
2541391-541391100.839100.84
3564869-564869105.212105.21
4554340-554340103.251103.25
5554211-554211103.227103.23
6542341-542341101.016101.02
30min1550633-550633102.561102.581.55102.56102.581.55
2541765-541765100.909100.91
3564312-564312105.109105.11
4551931-551931102.802102.80
5554349-554349103.253103.25
6541563-541563100.871100.87
45min1550813-550813102.594102.321.30102.59102.311.30
2540695-540695100.710100.71
3559352-559352104.185104.18
4551500-551500102.722102.72
5552189-552189102.850102.85
6541355-541355100.833100.83
极限1549326-549326102.317102.511.81102.32102.511.81
2537794-537794100.169100.17
3566488-566488105.514105.51
4554747-554747103.327103.33
5550840-550840102.599102.60
6542849-542849101.111101.11
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