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)10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%
111.913764783773593772463774793759703769060.18
211.913773243771263772250.04
单位质量响应值RSD%判断
31646.1831672.960.06数据可信
供试品溶液-2024072521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%
5min1231131-23113155.33650.3417.8255.3450.3417.83
2227398-22739854.44254.44
3234026-23402656.02956.03
4195483-19548346.80146.80
5233663-23366355.94255.94
6139842-13984233.48033.48
10min1272207-27220765.17059.8213.9965.2659.9013.99
2269061-26906164.41764.51
3270944-27094464.86864.96
4236394-23639456.59656.67
5266557-26655763.81763.91
6184054-18405444.06544.12
15min1300787-30078772.01366.5111.4272.2166.7011.43
2297157-29715771.14371.34
3296506-29650670.98871.19
4262852-26285262.93063.10
5290104-29010469.45569.65
6219482-21948252.54752.68
20min1321455-32145576.96171.588.9077.2871.888.92
2317563-31756376.02976.35
3313641-31364175.09075.41
4285667-28566768.39368.67
5304282-30428272.84973.16
6251391-25139160.18660.40
30min1349009-34900983.55878.656.3084.0179.076.33
2337083-33708380.70281.15
3342319-34231981.95682.40
4318569-31856976.27076.66
5332228-33222879.54079.98
6291923-29192369.89070.21
45min1370301-37030188.65585.214.4189.2485.754.45
2368212-36821288.15588.73
3365049-36504987.39887.98
4347025-34702583.08383.60
5355591-35559185.13385.70
6329260-32926078.82979.26
60min1382430-38243091.55988.553.0192.3089.243.06
2380959-38095991.20791.93
3372767-37276789.24689.97
4362941-36294186.89387.55
5366657-36665787.78388.49
6353398-35339884.60885.17
90min1392166-39216693.89092.051.6394.7892.881.67
2390305-39030593.44494.32
3387492-38749292.77193.65
4378472-37847290.61191.41
5380105-38010591.00291.86
6378371-37837190.58791.29
120min1396434-39643494.91293.421.1495.9694.411.16
2393539-39353994.21995.25
3391166-39116693.65194.68
4386009-38600992.41693.37
5384934-38493492.15993.17
6389096-38909693.15594.01
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1395843-39584394.77095.070.8795.9796.220.86
2398809-39880995.48096.67
3401648-40164896.16097.35
4392244-39224493.90995.02
5394790-39479094.51895.68
6399265-39926595.59096.60
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)10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%
111.913756853756783758003773423771893763390.23
211.913770973767833769400.06
单位质量响应值RSD%判断
31598.5731649.030.12数据可信
供试品溶液-2024072621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%
5min1224896-22489653.90451.0315.8453.9051.0415.84
2194376-19437646.58946.59
3237750-23775056.98556.99
4159531-15953138.23738.24
5206928-20692849.59749.60
6254068-25406860.89660.90
10min1253701-25370160.80858.6411.4860.9058.7311.49
2235592-23559256.46856.55
3264489-26448963.39463.49
4198178-19817847.50047.56
5237228-23722856.86056.94
6278813-27881366.82766.93
15min1278719-27871966.80564.149.5567.0064.329.57
2260143-26014362.35262.52
3284593-28459368.21368.41
4224343-22434353.77253.91
5260569-26056962.45462.63
6297196-29719671.23371.45
20min1303219-30321972.67769.358.4472.9869.648.45
2281368-28136867.44067.72
3305260-30526073.16673.48
4249453-24945359.79060.02
5279489-27948966.98967.27
6317228-31722876.03576.37
30min1336542-33654280.66476.547.0981.0976.947.11
2310145-31014574.33774.73
3336901-33690180.75081.19
4283992-28399268.06968.40
5307200-30720073.63174.02
6341131-34113181.76482.22
45min1365781-36578187.67283.045.5688.2383.585.59
2337345-33734580.85681.37
3361955-36195586.75587.33
4320417-32041776.79977.24
5331155-33115579.37379.89
6362132-36213286.79787.39
60min1378711-37871190.77186.844.6191.4887.514.64
2352032-35203284.37785.02
3376725-37672590.29591.01
4343392-34339282.30682.88
5346446-34644683.03883.69
6376443-37644390.22890.97
90min1389363-38936393.32490.033.8394.1890.843.87
2366873-36687387.93488.72
3389851-38985193.44194.31
4362068-36206886.78287.49
5359213-35921386.09886.88
6386282-38628292.58693.48
120min1397017-39701795.15991.354.2596.1792.324.26
2372898-37289889.37890.31
3395994-39599494.91495.94
4374450-37445089.75090.61
5355977-35597785.32286.25
6390492-39049293.59594.64
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1398090-39809095.41692.752.7296.5993.872.75
2380327-38032791.15992.24
3396716-39671695.08796.27
4381677-38167791.48292.49
5371979-37197989.15890.23
6392929-39292994.17995.38
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)10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%
111.913778683775453776963773303771303775140.08
211.913770363768213769280.05
单位质量响应值RSD%判断
31697.2331648.030.11数据可信
供试品溶液-2024072621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%
5min1263745-26374563.11851.6425.7163.1251.6425.71
2226783-22678354.27354.27
3130645-13064531.26531.27
4258762-25876261.92661.93
5164218-16421839.30039.30
6250480-25048059.94459.94
10min1291265-29126569.70459.1122.0569.8159.2022.06
2262158-26215862.73862.83
3164889-16488939.46039.51
4288364-28836469.01069.11
5192873-19287346.15746.22
6282448-28244867.59467.69
15min1309778-30977874.13564.5619.1674.3664.7519.18
2286011-28601168.44768.64
3192905-19290546.16546.28
4310122-31012274.21774.44
5216560-21656051.82651.97
6303321-30332172.58972.80
20min1328000-32800078.49569.3316.5878.8469.6216.59
2305984-30598473.22773.54
3218213-21821352.22252.42
4326692-32669278.18278.52
5240212-24021257.48657.72
6319075-31907576.36076.69
30min1355266-35526685.02176.3512.9685.5076.7613.01
2333013-33301379.69580.13
3257282-25728261.57161.85
4347385-34738583.13583.61
5276859-27685966.25766.58
6344349-34434982.40882.87
45min1379779-37977990.88782.6610.0491.5083.1910.10
2354000-35400084.71885.28
3294968-29496870.59070.97
4368275-36827588.13488.74
5309677-30967774.11074.55
6365691-36569187.51588.11
60min1394148-39414894.32686.288.0595.0986.958.11
2367148-36714887.86488.57
3318360-31836076.18876.69
4375888-37588889.95690.71
5332305-33230579.52680.08
6375330-37533089.82290.57
90min1403064-40306496.45989.866.1097.3990.686.18
2378032-37803290.46991.32
3341176-34117681.64982.28
4383955-38395591.88692.79
5356199-35619985.24485.93
6390597-39059793.47694.37
120min1403482-40348296.55990.965.4097.6591.935.49
2379264-37926490.76491.77
3347477-34747783.15783.92
4390114-39011493.36094.42
5366106-36610687.61588.45
6394027-39402794.29795.35
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1405784-40578497.11092.184.7398.3693.294.82
2384172-38417291.93893.09
3357906-35790685.65286.56
4394092-39409294.31295.53
5370320-37032088.62389.60
6398709-39870995.41796.62
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