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%
111.963845693834423838833845473838973840680.13
2 12.003850453849403849920.02
单位质量响应值RSD%判断
32112.7132082.670.07数据可信
供试品溶液-6021201批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1385729-38572990.70688.984.8890.7188.984.88
2406221-40622195.52595.52
3360158-36015884.69384.69
4364874-36487485.80285.80
5389896-38989691.68691.69
6363419-36341985.46085.46
10min1388846-38884691.43991.583.2691.5991.733.26
2409093-40909396.20096.36
3372856-37285687.67987.82
4381769-38176989.77589.92
5397953-39795393.58093.73
6386175-38617590.81190.95
15min1389788-38978891.66091.533.3591.9691.833.35
2409436-40943696.28196.60
3373762-37376287.89288.18
4384240-38424090.35690.65
5398456-39845693.69994.01
6379703-37970389.28989.58
20min1387115-38711591.03291.603.3191.4992.063.31
2409089-40908996.19996.68
3371094-37109487.26487.70
4382871-38287190.03490.48
5396846-39684693.32093.79
6390212-39021291.76092.20
30min1388232-38823291.29491.703.0191.9092.313.02
2407210-40721095.75796.40
3373940-37394087.93488.51
4381813-38181389.78590.38
5398014-39801493.59594.22
6390565-39056591.84392.44
45min1388880-38888091.44790.822.2792.2191.582.27
2391017-39101791.94992.75
3371268-37126887.30588.03
4381740-38174089.76890.51
5396478-39647893.23494.01
6387996-38799691.23991.99
60min1387368-38736891.09191.882.6292.0092.792.63
2407998-40799895.94396.90
3378562-37856289.02189.89
4383970-38397090.29291.18
5395059-39505992.90093.83
6391344-39134492.02692.93
极限1382021-38202189.83491.522.6990.9092.582.69
2405313-40531395.31196.42
3378989-37898989.12190.14
4380333-38033389.43790.48
5393677-39367792.57593.66
6394766-39476692.83193.89
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%
111.963856023850983852153846023851203851270.10
2 12.003858693863383861040.09
单位质量响应值RSD%判断
32201.2532175.330.06数据可信
供试品溶液-6021201批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1397446-39744693.19890.584.0693.2090.584.06
2363974-36397485.34985.35
3402872-40287294.47094.47
4396295-39629592.92892.93
5371192-37119287.04287.04
6385826-38582690.47390.47
10min1393969-39396992.38393.641.9392.5493.791.94
2401902-40190294.24394.39
3408204-40820495.72195.88
4405247-40524795.02795.18
5387172-38717290.78990.93
6399451-39945193.66893.82
15min1400887-40088794.00593.501.3994.3193.811.38
2404072-40407294.75295.05
3391698-39169891.85092.17
4404942-40494294.95695.27
5393357-39335792.23992.54
6397423-39742393.19393.50
20min1400391-40039193.88993.921.6594.3594.381.65
2401048-40104894.04394.50
3410098-41009896.16596.63
4402647-40264794.41894.89
5389600-38960091.35891.81
6399280-39928093.62894.09
30min1398993-39899393.56193.981.7794.1894.601.77
2402741-40274194.44095.05
3411411-41141196.47397.10
4401586-40158694.16994.80
5389385-38938591.30891.91
6400556-40055693.92794.55
45min1399397-39939793.65693.801.3794.4394.581.36
2402995-40299594.49995.27
3407102-40710295.46296.25
4402269-40226994.32995.11
5391414-39141491.78492.54
6396930-39693093.07793.85
60min1402159-40215994.30394.031.8295.2494.961.82
2404289-40428994.80395.73
3409928-40992896.12597.08
4402519-40251994.38895.33
5388145-38814591.01791.92
6398880-39888093.53494.46
极限1393107-39310792.18193.531.7693.2794.621.75
2401083-40108394.05195.14
3409670-40967096.06597.17
4402059-40205994.28095.38
5390170-39017091.49292.55
6397107-39710793.11994.20
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%
111.963857083857113852593854113856963855570.06
2 12.003853313849563851440.07
单位质量响应值RSD%判断
32237.2132095.330.32数据可信
供试品溶液-6021301批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1394466-39446692.56396.092.9492.5696.092.94
2427370-427370100.284100.28
3419131-41913198.35198.35
4407508-40750895.62395.62
5407889-40788995.71395.71
6400588-40058894.00094.00
10min1406069-40606995.28698.182.7095.4498.342.70
2437964-437964102.770102.94
3424298-42429899.56399.73
4416354-41635497.69997.86
5412158-41215896.71596.87
6413472-41347297.02397.18
15min1398145-39814593.42698.033.3793.7498.353.37
2439470-439470103.123103.46
3427028-427028100.204100.53
4415352-41535297.46497.79
5412251-41225196.73697.06
6414314-41431497.22097.54
20min1409727-40972796.14497.941.9796.6198.431.98
2429783-429783100.850101.36
3425618-42561899.873100.37
4412543-41254396.80597.29
5413082-41308296.93197.41
6413564-41356497.04497.52
30min1410368-41036896.29598.012.8796.9298.662.87
2438907-438907102.991103.67
3425072-42507299.745100.41
4411170-41117096.48397.13
5411402-41140296.53797.18
6409044-40904495.98496.63
45min1408626-40862695.88697.402.9296.6898.222.92
2436472-436472102.420103.27
3419346-41934698.40199.23
4411451-41145196.54997.36
5400894-40089494.07194.88
6413795-41379597.09997.90
60min1405826-40582695.22996.743.9396.1897.713.91
2437724-437724102.714103.73
3421650-42165098.94299.94
4389804-38980491.46992.44
5407265-40726595.56696.53
6411245-41124596.50097.46
极限1406471-40647195.38097.102.5296.4998.242.52
2432313-432313101.444102.64
3420177-42017798.59699.75
4407084-40708495.52496.64
5407564-40756495.63796.76
6409233-40923396.02897.15
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%
111.963851683864163864813856553852323857900.17
2 12.003857823864733861280.13
单位质量响应值RSD%判断
32256.6932177.330.18数据可信
供试品溶液-6021301批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1419738-41973898.33892.605.1398.3492.605.13
2381247-38124789.32089.32
3382285-38228589.56389.56
4383578-38357889.86689.87
5381676-38167689.42089.42
6422937-42293799.08799.09
10min1423380-42338099.19195.983.6899.3596.133.68
2391989-39198991.83791.99
3394785-39478592.49292.64
4407091-40709195.37595.52
5410980-41098096.28696.43
6429765-429765100.687100.85
15min1415249-41524997.28696.483.6597.6296.793.65
2388533-38853391.02791.33
3402660-40266094.33794.64
4417142-41714297.73098.04
5414078-41407897.01297.32
6433115-433115101.472101.80
20min1407919-40791995.56995.724.4296.0696.204.42
2381160-38116089.30089.75
3398428-39842893.34593.81
4414553-41455397.12397.59
5414194-41419497.03997.51
6435156-435156101.950102.45
30min1418059-41805997.94494.684.7798.6095.314.76
2383896-38389689.94190.54
3390235-39023591.42692.04
4387284-38728490.73491.37
5415768-41576897.40898.04
6429384-429384100.598101.27
45min1412036-41203696.53395.543.7697.3596.343.76
2387148-38714890.70291.45
3394093-39409392.33093.10
4410545-41054596.18496.97
5412691-41269196.68797.48
6430320-430320100.817101.66
60min1419688-41968898.32696.054.1999.3097.004.19
2387392-38739290.76091.66
3393328-39332892.15093.07
4411509-41150996.41097.35
5414062-41406297.00897.96
6433911-433911101.658102.67
极限1417433-41743397.79895.573.5798.9496.683.58
2389280-38928091.20292.26
3395243-39524392.59993.68
4405683-40568395.04596.15
5410756-41075696.23397.35
6429095-429095100.530101.71
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