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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
115.224804904807744807474803794811594807100.07
215.224825944823414824680.04
单位质量响应值RSD%判断
31584.1031699.610.26数据可信
供试品溶液-24080501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%
5min1252632-25263247.52249.504.7847.5249.504.78
2243648-24364845.83245.83
3269460-26946050.68750.69
4265012-26501249.85049.85
5271097-27109750.99550.99
6277049-27704952.11552.11
10min1353151-35315166.43068.112.5966.5168.192.59
2350542-35054265.93966.02
3362032-36203268.10068.18
4370867-37086769.76269.85
5374283-37428370.40570.49
6361626-36162668.02468.11
15min1394992-39499274.30074.732.0074.4974.932.00
2389232-38923273.21773.40
3391299-39129973.60673.80
4406109-40610976.39276.59
5408168-40816876.77976.98
6393953-39395374.10574.31
20min1414742-41474278.01578.102.1278.3378.422.11
2410746-41074677.26477.57
3407111-40711176.58076.90
4423201-42320179.60779.93
5428289-42828980.56480.89
6407184-40718476.59476.92
30min1436540-43654082.11681.732.0482.5682.182.04
2429322-42932280.75881.20
3424943-42494379.93480.38
4442604-44260483.25683.72
5446549-44654983.99984.46
6426870-42687080.29780.75
45min1451146-45114684.86384.242.2785.4484.832.26
2440716-44071682.90183.47
3437149-43714982.23082.81
4458707-45870786.28686.88
5459959-45995986.52187.13
6439387-43938782.65183.24
60min1457935-45793586.14085.462.3686.8686.182.36
2446202-44620283.93384.64
3443227-44322783.37484.09
4465765-46576587.61388.36
5467134-46713487.87188.62
6445573-44557383.81584.54
极限1474516-47451689.25988.042.1990.1288.912.19
2458527-45852786.25287.10
3459323-45932386.40187.26
4481138-48113890.50591.39
5475808-47580889.50290.40
6458884-45888486.31987.18
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
115.224814584807204807934806574811754809610.08
215.224836784835614836200.02
单位质量响应值RSD%判断
31600.5931775.300.39数据可信
供试品溶液-24080502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%
5min1279146-27914652.43352.110.7352.4352.110.73
2276314-27631451.90151.90
3278433-27843352.29952.30
4278305-27830552.27552.27
5273800-27380051.42951.43
6278516-27851652.31552.31
10min1386664-38666472.62872.121.0672.7272.211.06
2382146-38214671.78071.87
3385593-38559372.42772.51
4386717-38671772.63872.73
5376490-37649070.71770.80
6386138-38613872.53072.62
15min1419163-41916378.73378.080.9978.9478.290.98
2411641-41164177.32077.53
3418431-41843178.59578.80
4418380-41838078.58678.79
5409472-40947276.91277.12
6417018-41701878.33078.54
20min1433578-43357881.44081.130.7481.7881.470.74
2428699-42869980.52480.86
3434249-43424981.56681.91
4434000-43400081.52081.86
5427062-42706280.21680.55
6434017-43401781.52381.86
30min1451326-45132684.77484.300.7285.2584.770.72
2445243-44524383.63184.10
3452244-45224484.94685.42
4450670-45067084.65185.13
5444725-44472583.53484.00
6448481-44848184.24084.71
45min1463379-46337987.03886.680.8087.6587.290.80
2456389-45638985.72586.33
3465287-46528787.39688.01
4463404-46340487.04387.66
5457343-45734385.90486.51
6462892-46289286.94687.56
60min1469262-46926288.14387.910.7488.9088.660.74
2464101-46410187.17487.93
3471699-47169988.60189.36
4470873-47087388.44689.21
5463586-46358687.07787.82
6468558-46855888.01188.77
极限1474482-47448289.12389.520.6690.0390.420.66
2473423-47342388.92589.82
3480208-48020890.19991.11
4479035-47903589.97990.89
5473544-47354488.94789.84
6478883-47888389.95090.86
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