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%
112.134864064854734855864854784856104857110.09
212.034893274894264893760.02
单位质量响应值RSD%判断
40042.1340679.631.12数据可信
供试品溶液-2024010911批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1329891-32989161.06069.2510.0661.0669.2510.06
2407639-40763975.45175.45
3430177-43017779.62279.62
4367993-36799368.11268.11
5360044-36004466.64166.64
6349196-34919664.63364.63
10min1434679-43467980.45585.545.2480.5985.695.25
2483035-48303589.40689.57
3498290-49829092.22992.41
4461001-46100185.32785.48
5451422-45142283.55483.70
6444325-44432582.24182.38
15min1479190-47919088.69492.303.1089.0192.653.11
2510694-51069494.52594.89
3522540-52254096.71897.10
4495116-49511691.64291.98
5492148-49214891.09391.43
6492425-49242591.14491.47
20min1496630-49663091.92295.532.2692.4396.082.28
2521098-52109896.45197.03
3530346-53034698.16398.76
4511461-51146194.66795.21
5522986-52298696.80097.34
6514205-51420595.17595.70
30min1509126-50912694.23597.602.0094.9598.362.01
2529198-52919897.95098.74
3537196-53719699.431100.25
4524118-52411897.01097.76
5526163-52616397.38898.14
6537910-53791099.563100.30
45min1510900-51090094.56398.402.1295.4999.382.13
2531285-53128598.33699.34
3542801-542801100.468101.50
4538751-53875199.718100.69
5529636-52963698.03199.00
6536315-53631599.267100.23
60min1508428-50842894.10697.932.1095.2499.132.11
2530950-53095098.27499.50
3540933-540933100.122101.38
4528302-52830297.78498.98
5530385-53038598.17099.36
6535549-53554999.126100.31
极限1510734-51073494.53398.171.9895.8899.581.99
2532114-53211498.49099.94
3539610-53961099.877101.36
4528321-52832197.78899.20
5533160-53316098.684100.09
6538340-53834099.642101.04
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%
112.134865814868654877364866764876884871090.12
212.034877854878494878170.01
单位质量响应值RSD%判断
40157.3840550.040.69数据可信
供试品溶液-2024010911批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1311065-31106557.58467.327.1757.5867.327.18
2378920-37892070.14570.14
3378022-37802269.97869.98
4368745-36874568.26168.26
5370464-37046468.57968.58
6374666-37466669.35769.36
10min1404804-40480474.93684.665.7875.0684.815.79
2465943-46594386.25486.41
3468134-46813486.66086.82
4462233-46223385.56785.72
5463537-46353785.80985.96
6479253-47925388.71888.87
15min1458402-45840284.85890.243.0685.1590.583.07
2498699-49869992.31892.67
3486455-48645590.05190.40
4491152-49115290.92191.26
5493024-49302491.26791.61
6497070-49707092.01692.37
20min1487869-48786990.31393.512.1390.8094.052.14
2516093-51609395.53896.09
3497955-49795592.18092.73
4504828-50482893.45294.00
5509817-50981794.37694.92
6514270-51427095.20095.76
30min1516677-51667795.64696.321.9796.3397.061.97
2527896-52789697.72398.49
3505039-50503993.49294.24
4514809-51480995.30096.05
5533616-53361698.78299.54
6523816-52381696.96797.73
45min1533099-53309998.68696.921.8999.5897.881.87
2533216-53321698.70899.69
3508412-50841294.11695.08
4516667-51666795.64496.61
5521471-52147196.53397.51
6528340-52834097.80598.79
60min1525454-52545497.27196.591.6398.3997.761.62
2531894-53189498.46399.66
3508823-50882394.19295.36
4515419-51541995.41396.59
5521262-52126296.49597.68
6527803-52780397.70698.91
极限1525256-52525697.23496.801.5798.5798.191.56
2531784-53178498.44399.86
3510080-51008094.42595.80
4516884-51688495.68497.07
5523608-52360896.92998.33
6529981-52998198.10999.53
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%
112.134905994907634907964899514895704903360.12
212.034937654932834935240.07
单位质量响应值RSD%判断
40423.4141024.441.05数据可信
供试品溶液-JPS5451批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1408705-40870574.97376.652.2774.9776.652.27
2412093-41209375.59475.59
3408811-40881174.99274.99
4424535-42453577.87777.88
5421333-42133377.28977.29
6431769-43176979.20479.20
10min1474393-47439387.02387.390.9187.1987.560.92
2473029-47302986.77386.94
3470947-47094786.39186.56
4477571-47757187.60687.78
5480262-48026288.09988.27
6482061-48206188.42988.61
15min1497543-49754391.26991.580.7491.6391.940.74
2496766-49676691.12791.49
3495671-49567190.92691.28
4500344-50034491.78392.15
5499133-49913391.56191.93
6505856-50585692.79493.17
20min1509391-50939193.44393.550.5994.0194.120.60
2507645-50764593.12393.69
3506964-50696492.99893.56
4511189-51118993.77394.34
5509478-50947893.45994.03
6515300-51530094.52795.11
30min1517974-51797495.01795.110.5695.7995.880.56
2516158-51615894.68495.45
3516240-51624094.69995.47
4518917-51891795.19095.97
5517615-51761594.95195.73
6523962-52396296.11696.90
45min1525448-52544896.38896.320.4297.3797.310.42
2522959-52295995.93296.91
3523528-52352896.03697.01
4524866-52486696.28297.27
5524566-52456696.22797.22
6529122-52912297.06298.06
60min1527895-52789596.83796.480.5998.0397.680.59
2523610-52361096.05197.24
3524662-52466296.24497.44
4526635-52663596.60697.81
5522303-52230395.81197.01
6530711-53071197.35498.57
极限1527396-52739696.74696.610.4998.1698.020.50
2525304-52530496.36297.77
3524550-52455096.22497.63
4526869-52686996.64998.07
5524458-52445896.20797.62
6531258-53125897.45498.89
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%
112.134925844936124923614922954909044923510.20
212.034942044926114934080.23
单位质量响应值RSD%判断
40589.5341014.800.74数据可信
供试品溶液-JPS5451批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1398721-39872172.99973.413.0273.0073.423.01
2386690-38669070.79770.80
3416494-41649476.25376.25
4413647-41364775.73275.73
5400230-40023073.27673.28
6390135-39013571.42771.43
10min1462303-46230384.64085.482.6484.8085.652.64
2458168-45816883.88384.04
3484110-48411088.63388.80
4480325-48032587.94088.11
5462439-46243984.66584.83
6454134-45413483.14483.30
15min1489436-48943689.60890.362.2989.9690.722.29
2492670-49267090.20090.54
3508899-50889993.17193.54
4503786-50378692.23592.60
5489030-48903089.53389.88
6477508-47750887.42487.77
20min1501748-50174891.86292.682.1392.4193.242.13
2509115-50911593.21193.75
3519553-51955395.12295.70
4514318-51431894.16394.73
5503823-50382392.24292.79
6488902-48890289.51090.05
30min1512966-51296693.91694.822.2894.6795.582.28
2523212-52321295.79196.54
3532362-53236297.46798.25
4526979-52697996.48197.26
5511903-51190393.72194.48
6500093-50009391.55992.30
45min1517851-51785194.81095.602.2995.7796.572.29
2527874-52787496.64597.61
3535824-53582498.10199.10
4531062-53106297.22998.22
5517383-51738394.72495.69
6502899-50289992.07393.01
60min1518805-51880594.98595.792.1996.1696.972.19
2528595-52859596.77797.96
3537838-53783898.46999.69
4530249-53024997.08098.29
5518132-51813294.86196.04
6505502-50550292.54993.69
极限1521204-52120495.42496.212.1896.8197.612.17
2531031-53103197.22398.62
3540717-54071798.996100.43
4532554-53255497.50298.93
5518694-51869494.96496.35
6508944-50894493.17994.53
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