利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.863166643160883159963159743159173161280.10
210.023161523159643160580.05
单位质量响应值RSD%判断
32061.6631542.711.16数据可信
供试品溶液-2批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1219834-21983461.96869.8114.0361.9769.8114.03
2279783-27978378.86778.87
3219599-21959961.90261.90
4287087-28708780.92680.93
5210151-21015159.23959.24
6269497-26949775.96775.97
10min1313396-31339688.34291.964.9088.4592.084.92
2341536-34153696.27496.41
3313338-31333888.32688.43
4347001-34700197.81597.95
5310410-31041087.50087.60
6331784-33178493.52593.65
15min1337336-33733695.09097.273.5095.3497.543.51
2359717-359717101.399101.69
3337761-33776195.21095.46
4360068-360068101.498101.80
5331989-33198993.58393.83
6343547-34354796.84197.12
20min1343994-34399496.96798.963.0597.3899.393.07
2365305-365305102.974103.44
3344626-34462697.14597.55
4363709-363709102.525102.99
5340588-34058896.00796.41
6348102-34810298.12598.57
30min1350026-35002698.667100.542.6899.24101.132.69
2370539-370539104.450105.08
3351008-35100898.94499.52
4366859-366859103.412104.05
5348405-34840598.21198.77
6353070-35307099.526100.13
45min1354049-35404999.802101.302.45100.54102.072.47
2373016-373016105.148105.95
3355188-355188100.123100.86
4367872-367872103.698104.51
5351840-35184099.17999.90
6354274-35427499.865100.64
60min1354923-354923100.048101.352.26100.95102.292.28
2372065-372065104.880105.86
3356056-356056100.367101.27
4367363-367363103.555104.54
5351990-35199099.221100.11
6354924-354924100.048100.99
极限1354795-354795100.012101.191.88101.08102.291.90
2370136-370136104.336105.49
3355580-355580100.233101.30
4364329-364329102.699103.86
5352946-35294699.491100.55
6356047-356047100.365101.47
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.863155053158403158423163423158723158800.10
210.023158233160013159120.04
单位质量响应值RSD%判断
32036.5131528.141.14数据可信
供试品溶液-2批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1252804-25280471.30666.024.8271.3166.024.82
2217863-21786361.45161.45
3237192-23719266.90366.90
4232043-23204365.45065.45
5232212-23221265.49865.50
6232320-23232065.52965.53
10min1323299-32329991.19086.922.9391.3187.032.93
2305121-30512186.06386.17
3312367-31236788.10788.22
4302390-30239085.29385.40
5308435-30843586.99887.11
6297317-29731783.86283.97
15min1339932-33993295.88292.792.1096.1593.042.10
2329038-32903892.80993.05
3333811-33381194.15594.41
4322745-32274591.03491.29
5326290-32629092.03492.29
6322042-32204290.83691.08
20min1345177-34517797.36195.231.5497.7995.641.55
2335547-33554794.64595.05
3342942-34294296.73197.15
4334288-33428894.29094.69
5335517-33551794.63695.04
6332155-33215593.68894.09
30min1350091-35009198.74796.871.1299.3497.431.13
2342574-34257496.62797.19
3345615-34561597.48598.06
4340497-34049796.04196.60
5341928-34192896.44597.01
6339804-33980495.84696.40
45min1353162-35316299.61397.961.11100.3798.691.11
2344170-34417097.07797.80
3349755-34975598.65299.39
4343784-34378496.96897.69
5348592-34859298.32499.05
6344266-34426697.10497.82
60min1354736-354736100.05798.711.31100.9899.601.31
2344189-34418997.08297.96
3355095-355095100.159101.06
4345836-34583697.54798.43
5351517-35151799.149100.04
6348417-34841798.27599.15
极限1352238-35223899.35398.430.55100.4499.480.56
2347668-34766898.06499.11
3350323-35032398.81399.88
4347878-34787898.12399.17
5348057-34805798.17499.23
6347593-34759398.04399.08
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