利伐沙班颗粒项目信息
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800
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%
112.724983984984784987414993324987454987390.08
212.655027645024555026100.05
单位质量响应值RSD%判断
39209.0439732.020.94数据可信
影响因素30天-供试品溶液-2024010711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%
5min1324580-32458061.43162.361.7361.4362.361.73
2333693-33369363.15663.16
3323077-32307761.14761.15
4328610-32861062.19462.19
5338321-33832164.03264.03
6328759-32875962.22262.22
10min1394963-39496374.75275.490.7174.8575.590.71
2397907-39790775.30975.41
3397106-39710675.15875.26
4400629-40062975.82475.93
5402903-40290376.25576.36
6399570-39957075.62475.73
15min1425335-42533580.50080.920.3380.7381.150.33
2426392-42639280.70080.93
3428676-42867681.13381.36
4428034-42803481.01181.24
5428036-42803681.01281.25
6428750-42875081.14781.38
20min1440940-44094083.45483.570.2683.8183.930.25
2440169-44016983.30883.67
3442416-44241683.73384.10
4441747-44174783.60783.97
5440802-44080283.42883.80
6443129-44312983.86884.23
30min1457893-45789386.66286.620.2587.1687.120.25
2456134-45613486.32986.83
3459114-45911486.89387.40
4457238-45723886.53887.04
5456845-45684586.46486.97
6458723-45872386.81987.32
45min1468090-46809088.59288.970.3589.2489.620.35
2469339-46933988.82989.48
3470304-47030489.01189.66
4470852-47085289.11589.76
5469169-46916988.79789.45
6472830-47283089.48990.14
60min1475353-47535389.96790.000.3090.7690.800.30
2475481-47548189.99190.79
3475516-47551689.99890.79
4476039-47603990.09790.89
5473223-47322389.56490.36
6477644-47764490.40191.20
极限1480956-48095691.02791.130.4191.9792.080.40
2480174-48017490.87991.83
3480085-48008590.86391.81
4481984-48198491.22292.17
5480532-48053290.94791.90
6485164-48516491.82492.77
利伐沙班颗粒项目信息
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800
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%
112.724924994925154926384927804926774926220.03
212.654913604920174916880.10
单位质量响应值RSD%判断
38728.1438868.620.26数据可信
影响因素30天-供试品溶液-2024010711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%
5min1323635-32363562.31163.964.4662.3163.964.45
2317954-31795461.21761.22
3341008-34100865.65665.66
4347130-34713066.83466.83
5315722-31572260.78760.79
6347842-34784266.97266.97
10min1389199-38919974.93476.312.2375.0476.422.24
2386006-38600674.31974.42
3402747-40274777.54377.65
4401872-40187277.37477.49
5390680-39068075.21975.32
6407684-40768478.49378.60
15min1416696-41669680.22881.321.3380.4681.561.33
2417966-41796680.47380.70
3428366-42836682.47582.71
4421871-42187181.22581.47
5419280-41928080.72680.95
6430110-43011082.81183.05
20min1431786-43178683.13484.160.9883.5084.530.98
2434033-43403383.56683.93
3442163-44216385.13285.51
4434994-43499483.75184.13
5437755-43775584.28384.64
6441910-44191085.08385.46
30min1449042-44904286.45687.331.0586.9687.841.04
2451653-45165386.95987.46
3457943-45794388.17088.69
4447742-44774286.20686.72
5458755-45875588.32688.83
6456297-45629787.85388.38
45min1462995-46299589.14289.941.2189.7990.591.20
2467199-46719989.95290.60
3472755-47275591.02291.69
4458185-45818588.21688.88
5471772-47177290.83291.48
6469782-46978290.44991.12
60min1467597-46759790.02990.951.0190.8291.761.00
2473057-47305791.08091.87
3475705-47570591.59092.41
4465642-46564289.65290.46
5477568-47756891.94892.75
6474761-47476191.40892.23
极限1474468-47446891.35192.201.1492.3093.151.13
2478688-47868892.16493.11
3484297-48429793.24494.21
4470666-47066690.61991.57
5484065-48406593.19994.15
6480984-48098492.60693.58
利伐沙班颗粒项目信息
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800
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%
112.724859784859454864404867914867074863720.09
212.654925694921824923760.06
单位质量响应值RSD%判断
38236.7938923.001.26数据可信
影响因素30天-供试品溶液-2024010711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%
5min1317375-31737561.45663.365.6261.4663.365.62
2310755-31075560.17460.17
3351945-35194568.15068.15
4331910-33191064.27164.27
5307148-30714859.47659.48
6344128-34412866.63766.64
10min1393927-39392776.28076.852.7276.3876.962.73
2385300-38530074.60974.71
3411137-41113779.61279.73
4401532-40153277.75277.86
5384620-38462074.47874.58
6404817-40481778.38978.50
15min1429026-42902683.07683.351.5783.3183.591.57
2422996-42299681.90982.13
3439550-43955085.11485.36
4432676-43267683.78384.02
5423013-42301381.91282.14
6435508-43550884.33284.57
20min1445807-44580786.32686.621.0086.6986.991.01
2442684-44268485.72186.08
3453971-45397187.90788.29
4448331-44833186.81587.19
5442715-44271585.72786.09
6450428-45042887.22187.60
30min1464087-46408789.86689.930.5190.3890.450.52
2462390-46239089.53790.04
3468211-46821190.66491.20
4464680-46468089.98090.50
5461672-46167289.39889.90
6465598-46559890.15890.69
45min1476480-47648092.26592.350.4492.9393.020.45
2475477-47547792.07192.72
3480166-48016692.97993.66
4477519-47751992.46793.14
5474166-47416691.81792.47
6477796-47779692.52093.20
60min1484107-48410793.74293.850.3794.5694.660.37
2486341-48634194.17594.98
3486210-48621094.14994.99
4483722-48372293.66894.49
5481802-48180293.29694.10
6485653-48565394.04294.87
极限1489904-48990494.86594.950.5295.8495.930.53
2488779-48877994.64795.61
3493105-49310595.48596.48
4489139-48913994.71795.70
5487380-48738094.37695.34
6493726-49372695.60596.59
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