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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
112.103876423837383845033840813847763849480.41
212.013813633794743804180.36
单位质量响应值RSD%判断
31813.8831675.100.31数据可信
供试品溶液-6021201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%
5min1168817-16881740.14046.3324.0540.1446.3324.05
2259956-25995661.81061.81
3145386-14538634.56934.57
4184083-18408343.77043.77
5245934-24593458.47658.48
6165011-16501139.23539.23
10min1209619-20961949.84156.0817.6449.9156.1617.65
2287774-28777468.42568.53
3187432-18743244.56644.62
4237267-23726756.41556.49
5283196-28319667.33667.43
6209852-20985249.89749.96
15min1243289-24328957.84762.3014.3958.0062.4714.41
2310029-31002973.71673.93
3215498-21549851.23951.37
4264701-26470162.93863.11
5302192-30219271.85372.06
6236264-23626456.17756.33
20min1268000-26800063.72367.4012.3963.9767.6712.42
2327235-32723577.80778.15
3235249-23524955.93656.15
4293951-29395169.89370.17
5315818-31581875.09375.42
6260513-26051361.94362.18
30min1297884-29788470.82872.9710.2071.1873.3610.23
2346080-34608082.28882.76
3264559-26455962.90563.22
4311618-31161874.09474.48
5337380-33738080.21980.67
6283878-28387867.49867.84
45min1327980-32798077.98478.688.5978.4679.198.63
2366590-36659087.16587.77
3288403-28840368.57468.99
4336198-33619879.93880.45
5354506-35450684.29284.88
6311876-31187674.15574.61
60min1342171-34217181.35981.907.6781.9682.547.71
2374774-37477489.11189.86
3305563-30556372.65473.18
4348457-34845782.85383.50
5370228-37022888.03088.76
6325379-32537977.36677.95
90min1353468-35346884.04584.856.9384.7885.636.98
2386368-38636891.86792.77
3321600-32160076.46777.12
4356527-35652784.77285.56
5382646-38264690.98291.86
6340624-34062480.99181.70
120min1363172-36317286.35287.444.4787.2388.364.54
2389714-38971492.66393.72
3349378-34937883.07283.85
4367755-36775587.44288.37
5384152-38415291.34192.37
6352395-35239583.79084.64
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1416921-41692199.13292.244.47100.1593.304.47
2395540-39554094.04895.26
3374416-37441689.02689.94
4378033-37803389.88690.96
5392236-39223693.26394.44
6370521-37052188.09989.08
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
112.103839553832793825603841483828643833610.18
212.013780283822463801370.79
单位质量响应值RSD%判断
31682.7331651.710.07数据可信
供试品溶液-6021201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%
5min1213390-21339050.86250.005.3450.8650.005.34
2224181-22418153.43453.43
3212910-21291050.74750.75
4200999-20099947.90847.91
5192566-19256645.89845.90
6214651-21465151.16251.16
10min1243252-24325257.97958.673.3658.0658.753.36
2253549-25354960.43460.52
3252934-25293460.28760.37
4237706-23770656.65756.74
5235892-23589256.22556.30
6253514-25351460.42560.51
15min1274351-27435165.39265.681.5465.5765.861.55
2280557-28055766.87167.06
3272997-27299765.06965.25
4270494-27049464.47364.65
5274094-27409465.33165.50
6280944-28094466.96367.15
20min1296468-29646870.66370.511.3570.9570.801.36
2298592-29859271.17071.47
3298624-29862471.17771.47
4294644-29464470.22970.51
5288355-28835568.73069.01
6298355-29835571.11371.41
30min1321938-32193876.73477.151.4977.1477.561.48
2315250-31525075.14075.56
3326847-32684777.90478.32
4328229-32822978.23478.63
5326947-32694777.92878.32
6322955-32295576.97777.39
45min1344670-34467082.15282.421.1782.6982.961.16
2345623-34562382.38082.92
3348414-34841483.04583.59
4351766-35176683.84484.37
5339870-33987081.00881.53
6344477-34447782.10682.65
60min1357942-35794285.31686.671.5685.9987.351.54
2367813-36781387.66988.35
3359131-35913185.59986.28
4371321-37132188.50589.17
5366566-36656687.37188.03
6359046-35904685.57986.26
90min1369292-36929288.02190.461.9888.8491.281.96
2376905-37690589.83690.66
3379109-37910990.36191.18
4387483-38748392.35793.17
5388992-38899292.71793.52
6375371-37537189.47090.29
120min1396004-39600494.38892.151.9595.3593.121.92
2384617-38461791.67492.65
3381767-38176790.99591.97
4386550-38655092.13593.10
5394500-39450094.02994.99
6376363-37636389.70690.68
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1393105-39310593.69794.571.4894.8295.701.46
2397618-39761894.77395.90
3392082-39208293.45394.58
4396585-39658594.52695.65
5407846-40784697.21098.33
6393385-39338593.76494.89
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
112.103830403837733837563831553839913835430.11
212.013856823853893855360.06
单位质量响应值RSD%判断
31697.7732101.250.90数据可信
供试品溶液-6021301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%
5min1186761-18676144.19251.3012.5644.1951.3012.56
2235269-23526955.67055.67
3181847-18184743.02943.03
4223027-22302752.77452.77
5250894-25089459.36859.37
6223048-22304852.77952.78
10min1230651-23065154.57858.089.5654.6558.169.55
2261517-26151761.88161.97
3208320-20832049.29449.37
4251094-25109459.41559.50
5274760-27476065.01565.11
6246317-24631758.28558.37
15min1257177-25717760.85464.318.5861.0264.498.58
2291338-29133868.93869.13
3233582-23358255.27155.43
4277882-27788265.75465.94
5296600-29660070.18370.39
6274060-27406064.84965.03
20min1301914-30191471.44070.588.2371.7170.878.23
2328513-32851377.73478.05
3256070-25607060.59260.84
4294654-29465469.72270.02
5314643-31464374.45274.78
6293835-29383569.52969.82
30min1325216-32521676.95477.095.9577.3477.505.96
2333193-33319378.84279.28
3288348-28834868.23068.58
4334444-33444479.13879.55
5343864-34386481.36781.82
6329629-32962977.99878.41
45min1349617-34961782.72883.645.2683.2484.175.28
2362061-36206185.67386.24
3317873-31787375.21775.68
4359921-35992185.16685.71
5369628-36962887.46388.05
6361645-36164585.57486.11
60min1370627-37062787.70088.855.4888.3589.525.50
2399122-39912294.44295.16
3339171-33917180.25680.84
4383098-38309890.65091.34
5387748-38774891.75192.48
6373051-37305188.27388.95
90min1378069-37806989.46091.424.3790.2692.254.39
2389198-38919892.09492.97
3357586-35758684.61485.33
4401004-40100494.88795.73
5403666-40366695.51796.40
6388620-38862091.95792.79
120min1399664-39966494.57094.432.8895.5295.412.92
2400356-40035694.73495.76
3377225-37722589.26190.12
4402884-40288495.33296.33
5411268-41126897.31698.36
6403056-40305695.37396.36
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1407736-40773696.48096.062.3897.5897.202.42
2411579-41157997.39098.57
3389201-38920192.09593.10
4402085-40208595.14396.30
5417348-41734898.75599.96
6407926-40792696.52597.67
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
112.103847703842093817313811833814333826650.45
212.013800693819323810000.35
单位质量响应值RSD%判断
31625.2131723.560.22数据可信
供试品溶液-6021301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%
5min1239256-23925657.01447.9331.5557.0147.9331.55
2228231-22823154.38754.39
3199762-19976247.60347.60
4221041-22104152.67452.67
5242990-24299057.90457.90
675479-7547917.98617.99
10min1263273-26327362.73757.0418.9862.8357.1218.99
2261707-26170762.36462.45
3241392-24139257.52357.60
4247217-24721758.91159.00
5273015-27301565.05965.16
6149669-14966935.66635.70
15min1287058-28705868.40564.2515.4268.6064.4215.44
2290805-29080569.29869.49
3281373-28137367.05067.23
4273031-27303165.06365.25
5298701-29870171.18071.38
6186653-18665344.47944.57
20min1304842-30484272.64369.1912.4772.9669.4712.51
2310631-31063174.02374.33
3297480-29748070.88971.18
4291947-29194769.57069.86
5318266-31826675.84276.17
6218941-21894152.17352.34
30min1335560-33556079.96377.849.1380.4078.239.18
2350441-35044183.50983.94
3328870-32887078.36978.77
4325063-32506377.46277.87
5350116-35011683.43283.88
6269735-26973564.27764.53
45min1364625-36462586.88986.208.0787.4686.738.11
2401859-40185995.76296.33
3360289-36028985.85686.39
4357318-35731885.14885.69
5374146-37414689.15889.75
6312140-31214074.38274.74
60min1378887-37888790.28889.445.7891.0090.105.83
2403892-40389296.24696.98
3364061-36406186.75587.43
4372472-37247288.75989.44
5390960-39096093.16593.90
6341587-34158781.39981.88
90min1393546-39354693.78193.524.3494.6494.344.40
2418173-41817399.650100.54
3390021-39002192.94193.76
4389245-38924592.75693.59
5398396-39839694.93795.83
6365383-36538387.07087.69
120min1416935-41693599.35597.953.29100.3798.923.35
2431542-431542102.835103.89
3402506-40250695.91696.89
4405697-40569796.67797.66
5416489-41648999.248100.30
6392964-39296493.64294.40
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1412987-41298798.41499.182.5299.60100.322.57
2436030-436030103.905105.14
3413197-41319798.46499.60
4413069-41306998.43399.58
5416919-41691999.351100.57
6405098-40509896.53497.45
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