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%
114.844694954700714697674695504695394696840.06
214.874692084696784694430.08
单位质量响应值RSD%判断
31649.8731569.800.18数据可信
供试品溶液-1批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1115885-11588521.82120.336.0421.8220.336.04
298486-9848618.54518.54
3112011-11201121.09121.09
4111852-11185221.06121.06
5102793-10279319.35619.36
6106769-10676920.10420.10
10min1162576-16257630.61230.061.8330.6530.091.85
2155243-15524329.23229.26
3162789-16278930.65330.69
4159891-15989130.10730.14
5157472-15747229.65129.68
6159803-15980330.09030.12
15min1192471-19247136.24235.911.0236.3336.001.02
2188531-18853135.50035.58
3193450-19345036.42636.51
4189796-18979635.73835.82
5189142-18914235.61535.70
6190887-19088735.94336.03
20min1213474-21347440.19639.900.7340.3440.050.73
2210495-21049539.63539.77
3214105-21410540.31540.46
4211288-21128839.78539.93
5210469-21046939.63039.77
6211732-21173239.86840.01
30min1241261-24126145.42945.320.3845.6445.530.38
2240888-24088845.35845.56
3241745-24174545.52045.73
4240175-24017545.22445.44
5239154-23915445.03245.24
6240799-24079945.34245.55
45min1267652-26765250.39850.180.3750.6950.470.37
2266224-26622450.12950.41
3267147-26714750.30350.59
4265148-26514849.92650.21
5265676-26567650.02650.31
6267177-26717750.30850.59
60min1281592-28159253.02352.970.3353.4053.340.33
2281349-28134952.97753.34
3281683-28168353.04053.41
4280220-28022052.76453.13
5280379-28037952.79453.16
6282645-28264553.22153.59
极限1293328-29332855.23355.110.2355.7055.570.23
2292685-29268555.11155.56
3293153-29315355.20055.66
4291498-29149854.88855.35
5292559-29255955.08855.54
6292819-29281955.13755.59
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%
114.844675394678034673624672794675564675080.05
214.874657614660274658940.05
单位质量响应值RSD%判断
31503.2331331.140.39数据可信
供试品溶液-2批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1113762-11376221.55219.775.4821.5519.765.47
2101180-10118019.16919.17
3105171-10517119.92519.92
499953-9995318.93618.94
598436-9843618.64918.65
6107468-10746820.36020.36
10min1159706-15970630.25728.952.8430.2928.982.85
2151371-15137128.67828.71
3152960-15296028.97929.01
4150218-15021828.45928.49
5147224-14722427.89227.92
6155355-15535529.43229.47
15min1186226-18622635.28134.661.2135.3734.751.21
2181819-18181934.44634.53
3182096-18209634.49834.58
4183500-18350034.76434.84
5179885-17988534.08034.16
6184303-18430334.91735.00
20min1206801-20680139.17938.570.8339.3238.710.83
2202709-20270938.40438.54
3202994-20299438.45838.60
4203983-20398338.64538.78
5202238-20223838.31438.45
6202807-20280738.42238.56
30min1233468-23346844.23143.820.5344.4444.020.53
2230288-23028843.62843.83
3230420-23042043.65443.86
4230534-23053443.67543.88
5231751-23175143.90644.10
6231250-23125043.81144.02
45min1256950-25695048.68048.530.3348.9648.800.32
2255776-25577648.45748.73
3255664-25566448.43648.71
4257160-25716048.71948.99
5256281-25628148.55348.82
6255002-25500248.31148.59
60min1273834-27383451.87851.480.4252.2451.840.43
2271900-27190051.51251.87
3270531-27053151.25351.61
4271334-27133451.40551.76
5271092-27109251.35951.71
6271684-27168451.47151.83
极限1283635-28363553.73553.620.2554.1954.060.26
2283521-28352153.71454.15
3282507-28250753.52153.96
4283744-28374453.75654.20
5282552-28255253.53053.97
6282098-28209853.44453.89
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