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%
1 12.233826113830443825693821213829263826540.10
2 12.243833673832473833070.03
单位质量响应值RSD%判断
31288.1431315.930.07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%
5min1134017-13401732.31636.8916.0932.3236.8916.09
2151260-15126036.47436.47
3168761-16876140.69440.69
4122739-12273929.59629.60
5191608-19160846.20346.20
6149638-14963836.08236.08
10min1174704-17470442.12749.1613.8942.1849.2213.89
2201081-20108148.48748.55
3222318-22231853.60853.68
4174205-17420542.00642.06
5247774-24777459.74659.82
6203190-20319048.99649.06
15min1219195-21919552.85558.029.9952.9858.1610.01
2233305-23330556.25756.40
3257455-25745562.08162.24
4214291-21429151.67251.79
5278024-27802467.04067.22
6241384-24138458.20558.35
20min1250920-25092060.50564.967.9360.7265.207.95
2256609-25660961.87762.11
3287964-28796469.43769.70
4248074-24807459.81860.02
5300463-30046372.45172.74
6272309-27230965.66265.90
30min1295995-29599571.37474.565.6871.6974.905.70
2293662-29366270.81171.15
3329889-32988979.54779.92
4292535-29253570.53970.84
5328998-32899879.33279.74
6314119-31411975.74476.09
45min1336675-33667581.18382.614.1281.6183.084.14
2323012-32301277.88878.34
3361775-36177587.23587.74
4333626-33362680.44880.87
5352591-35259185.02185.56
6347835-34783583.87484.35
60min1362072-36207287.30787.723.1087.8788.333.11
2347239-34723983.73084.32
3380678-38067891.79492.45
4357447-35744786.19286.75
5367692-36769288.66289.35
6367554-36755488.62989.24
90min1381890-38189092.08692.302.5592.8093.062.54
2369636-36963689.13189.86
3397117-39711795.75796.56
4385425-38542592.93893.64
5374805-37480590.37791.21
6387770-38777093.50494.27
120min1389280-38928093.86894.472.1794.7395.382.15
2383514-38351492.47793.35
3403701-40370197.34598.31
4397595-39759595.87396.73
5381827-38182792.07193.05
6394713-39471395.17896.10
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1399998-39999896.45295.941.5397.4797.011.52
2390620-39062094.19195.22
3402966-40296697.16898.30
4397933-39793395.95496.97
5390729-39072994.21795.35
6405000-40500097.65898.73
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%
1 12.233823383822013824083823113816983821910.08
2 12.243835573839093837330.07
单位质量响应值RSD%判断
31250.2931350.740.23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%
5min1202293-20229348.78244.2115.4648.7844.2115.46
2126853-12685330.59030.59
3199690-19969048.15448.15
4186405-18640544.95044.95
5195773-19577347.20947.21
6189020-18902045.58145.58
10min1250278-25027860.35355.8310.4260.4355.9010.43
2183511-18351144.25344.30
3243571-24357158.73658.82
4236476-23647657.02557.10
5239650-23965057.79057.87
6235667-23566756.83056.91
15min1276934-27693466.78162.977.8266.9663.137.83
2222023-22202353.54053.66
3272586-27258665.73265.91
4269279-26927964.93565.10
5269978-26997865.10465.28
6255949-25594961.72161.89
20min1299497-29949772.22269.596.7372.5269.866.74
2249524-24952460.17160.39
3300525-30052572.47072.76
4296192-29619271.42571.70
5293560-29356070.79071.07
6292192-29219270.46070.73
30min1329378-32937879.42877.715.2479.8478.105.26
2288410-28841069.54869.86
3332845-33284580.26480.67
4331690-33169079.98580.38
5325807-32580778.56678.97
6325483-32548378.48878.88
45min1352027-35202784.88984.044.2685.4484.564.28
2319207-31920776.97577.41
3359430-35943086.67487.22
4358392-35839286.42486.95
5351333-35133384.72285.25
6350560-35056084.53585.06
60min1366124-36612488.28987.283.6988.9887.943.72
2335982-33598281.02081.58
3370364-37036489.31190.00
4373161-37316189.98690.66
5362574-36257487.43388.11
6363456-36345687.64588.31
90min1378885-37888591.36690.373.3492.2091.173.37
2350674-35067484.56385.26
3383747-38374792.53893.37
4384883-38488392.81293.64
5375390-37539090.52391.34
6374872-37487290.39891.21
120min1383183-38318392.40291.263.1093.3992.213.13
2356048-35604885.85986.69
3389607-38960793.95194.94
4383697-38369792.52693.51
5381261-38126191.93992.91
6376791-37679190.86191.82
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1385738-38573893.01893.852.0494.1694.952.07
2376564-37656490.80691.78
3398917-39891796.19697.34
4395962-39596295.48496.62
5389557-38955793.93995.06
6388287-38828793.63394.74
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%
1 12.233839993834733842013841313841463839900.08
2 12.243844013842633843320.03
单位质量响应值RSD%判断
31397.3831399.670.01数据可信
供试品溶液-6021401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%
5min1209154-20915450.27948.446.1050.2848.446.10
2220502-22050253.00753.01
3189664-18966445.59345.59
4195658-19565847.03447.03
5189302-18930245.50645.51
6204792-20479249.23049.23
10min1252429-25242960.68258.924.6260.7759.014.62
2262626-26262663.13363.22
3235502-23550256.61256.69
4243179-24317958.45858.54
5231598-23159855.67455.75
6245381-24538158.98759.07
15min1286183-28618368.79667.513.6168.9867.693.61
2296555-29655571.28971.48
3269089-26908964.68664.86
4279495-27949567.18867.36
5271171-27117165.18765.36
6282593-28259367.93368.11
20min1308506-30850674.16273.342.9574.4673.632.96
2319702-31970276.85377.17
3292927-29292770.41770.70
4305322-30532273.39773.68
5299505-29950571.99872.28
6304586-30458673.22073.51
30min1337935-33793581.23681.022.3381.6681.432.34
2350504-35050484.25884.70
3326421-32642178.46978.86
4337113-33711381.03981.45
5333601-33360180.19580.59
6336526-33652680.89881.31
45min1356694-35669485.74686.472.2886.3087.012.29
2373673-37367389.82790.41
3348284-34828483.72484.25
4360566-36056686.67787.22
5359055-35905586.31386.84
6359862-35986286.50787.06
60min1372156-37215689.46389.172.3290.1689.862.33
2384500-38450092.43093.16
3359861-35986186.50787.17
4372724-37272489.59990.29
5363610-36361087.40888.08
6372737-37273789.60290.30
90min1381436-38143691.69491.652.2992.5492.492.30
2396095-39609595.21896.10
3369916-36991688.92489.73
4384153-38415392.34793.19
5378522-37852290.99391.81
6377425-37742590.72991.57
120min1385094-38509492.57392.912.1193.5893.902.12
2399605-39960596.06197.10
3374459-37445990.01690.97
4389382-38938293.60494.60
5386238-38623892.84893.82
6384230-38423092.36593.36
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1393333-39333394.55494.981.9695.7196.121.97
2406441-40644197.70598.91
3382707-38270791.99993.11
4398542-39854295.80696.95
5395506-39550695.07696.20
6394027-39402794.72095.87
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