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 12.073747283742573745403739903737973742620.11
2 12.143738293744273741280.12
单位质量响应值RSD%判断
31007.6230817.790.44数据可信
供试品溶液-BXJVV51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%
5min1347068-34706884.74489.533.0184.7489.533.01
2361960-36196088.38088.38
3371710-37171090.76190.76
4378694-37869492.46692.47
5368948-36894890.08690.09
6371689-37168990.75690.76
10min1373689-37368991.24495.562.8991.3995.712.89
2391634-39163495.62695.77
3386416-38641694.35294.50
4407222-40722299.43299.59
5390875-39087595.44095.59
6398445-39844597.28997.44
15min1377500-37750092.17496.782.8792.4797.102.87
2397796-39779697.13097.44
3392195-39219595.76396.07
4411096-411096100.378100.70
5395997-39599796.69197.00
6403709-40370998.57498.89
20min1380690-38069092.95397.262.8293.4097.732.82
2401283-40128397.98298.45
3393624-39362496.11296.58
4414254-414254101.149101.64
5396290-39629096.76297.23
6403805-40380598.59799.08
30min1383965-38396593.75397.332.4594.3597.962.45
2402836-40283698.36198.99
3393591-39359196.10396.73
4411804-411804100.551101.21
5395175-39517596.49097.12
6404225-40422598.70099.34
45min1386338-38633894.33297.762.4295.0998.552.42
2402993-40299398.39999.19
3395392-39539296.54397.33
4414912-414912101.309102.13
5397643-39764397.09397.89
6404950-40495098.87799.68
60min1385547-38554794.13997.952.3795.0598.912.38
2402898-40289898.37699.34
3402942-40294298.38799.34
4412342-412342100.682101.67
5395436-39543696.55497.51
6407780-40778099.568100.54
极限1392544-39254495.84897.822.1596.9298.942.15
2401677-40167798.07899.20
3392141-39214195.74996.86
4414389-414389101.182102.34
5396930-39693096.91998.03
6405963-40596399.124100.26
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 12.073737363736163735383731503725553733190.13
2 12.143732573736443734500.08
单位质量响应值RSD%判断
30929.4930761.940.39数据可信
供试品溶液-BXJVV51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%
5min1351489-35148986.01086.052.7186.0186.052.71
2363230-36323088.88388.88
3346281-34628184.73584.74
4350023-35002385.65185.65
5361283-36128388.40688.41
6337674-33767482.62982.63
10min1391954-39195495.91194.980.7796.0595.120.77
2387773-38777394.88895.04
3383564-38356493.85894.00
4388350-38835095.02995.17
5390579-39057995.57595.72
6386564-38656494.59294.73
15min1396612-39661297.05196.481.1697.3596.781.16
2393264-39326496.23296.54
3387842-38784294.90595.20
4399611-39961197.78598.09
5397870-39787097.35997.67
6390527-39052795.56295.86
20min1400629-40062998.03498.061.0598.5098.531.05
2403399-40339998.71299.18
3405373-40537399.19599.65
4403531-40353198.74499.21
5396880-39688097.11797.59
6394649-39464996.57197.03
30min1402841-40284198.57597.921.0699.2098.551.06
2396244-39624496.96197.59
3395278-39527896.72597.35
4405965-40596599.34099.97
5402544-40254498.50399.13
6398123-39812397.42198.04
45min1399094-39909497.65998.061.1598.4598.851.14
2398657-39865797.55298.34
3393680-39368096.33497.12
4406302-40630299.422100.22
5402163-40216398.41099.20
6404612-40461299.00999.79
60min1399545-39954597.76998.141.3998.7299.091.38
2398495-39849597.51298.47
3392215-39221595.97596.92
4407327-40732799.673100.63
5402541-40254198.50299.46
6406200-40620099.397100.34
极限1410724-410724100.50499.391.46101.62100.501.45
2396464-39646497.01598.13
3407518-40751899.720100.82
4413115-413115101.089102.22
5402948-40294898.60299.72
6406191-40619199.395100.50
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