利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院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%
19.983257843261433260883261893262793260970.06
210.043265853262873264360.07
单位质量响应值RSD%判断
32675.0532513.550.36数据可信
长期6月-供试品溶液-2024010612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%
5min1227738-22773862.63266.219.9862.6366.219.98
2248609-24860968.37268.37
3267695-26769573.62173.62
4200099-20009955.03155.03
5243220-24322066.89066.89
6257154-25715470.72270.72
10min1297752-29775281.88781.344.6182.0381.484.62
2296535-29653581.55381.70
3304963-30496383.87184.03
4268989-26898973.97774.10
5300438-30043882.62682.77
6305833-30583384.11084.27
15min1323675-32367589.01788.772.3689.3489.092.37
2325764-32576489.59189.92
3328791-32879190.42490.77
4307618-30761884.60184.89
5324966-32496689.37289.70
6325756-32575689.58989.93
20min1334333-33433391.94892.141.4292.4792.661.43
2335618-33561892.30192.83
3341433-34143393.90194.45
4326867-32686789.89590.37
5336817-33681792.63193.16
6335074-33507492.15292.69
30min1343162-34316294.37694.900.9395.1095.630.93
2343458-34345894.45895.19
3350780-35078096.47197.23
4345257-34525794.95295.63
5346011-34601195.16095.90
6341748-34174893.98794.74
45min1348725-34872595.90696.240.9796.8497.180.97
2347583-34758395.59296.54
3355981-35598197.90298.88
4351488-35148896.66697.55
5349087-34908796.00696.95
6346730-34673095.35796.31
60min1350791-35079196.47496.540.7697.6297.690.74
2349107-34910796.01197.17
3353818-35381897.30798.50
4353279-35327997.15898.26
5352202-35220296.86298.02
6346933-34693395.41396.58
极限1352216-35221696.86697.280.7598.2398.650.74
2354908-35490897.60698.98
3356152-35615297.94999.36
4355869-35586997.87199.19
5353879-35387997.32398.70
6349204-34920496.03897.42
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院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%
19.983252723254083253293251713251043252570.04
210.043259623263313261460.09
单位质量响应值RSD%判断
32590.8832484.660.24数据可信
加速6月-供试品溶液-2024010612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%
5min1225198-22519862.04166.078.3662.0466.078.36
2239526-23952665.98865.99
3224807-22480761.93361.93
4256533-25653370.67470.67
5270958-27095874.64874.65
6221912-22191261.13661.14
10min1291506-29150680.30981.623.3180.4581.773.32
2300820-30082082.87583.02
3288521-28852179.48679.62
4304606-30460683.91884.07
5308462-30846284.98085.15
6283732-28373278.16778.30
15min1315431-31543186.90088.121.8087.2288.451.81
2321597-32159788.59988.93
3316934-31693487.31487.63
4323588-32358889.14789.49
5328509-32850990.50390.86
6313192-31319286.28386.59
20min1326270-32627089.88691.291.5590.4091.821.56
2330492-33049291.04991.58
3333021-33302191.74692.25
4334452-33445292.14092.68
5338779-33877993.33293.89
6325231-32523189.60090.10
30min1335517-33551792.43493.681.1693.1494.411.17
2341843-34184394.17694.91
3342996-34299694.49495.21
4341904-34190494.19394.94
5343423-34342394.61295.37
6334638-33463892.19192.89
45min1341288-34128894.02395.581.4094.9496.521.41
2348305-34830595.95796.90
3350055-35005596.43997.36
4347420-34742095.71396.67
5353350-35335097.34698.32
6341295-34129594.02594.93
60min1342772-34277294.43295.911.4395.5697.061.44
2349871-34987196.38897.54
3352250-35225097.04398.18
4349625-34962596.32097.49
5353067-35306797.26998.46
6341226-34122694.00695.12
极限1345055-34505595.06196.361.4296.3997.721.42
2348615-34861596.04297.41
3354486-35448697.65999.01
4351841-35184196.93198.31
5355292-35529297.88299.29
6343324-34332494.58495.91
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