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%
110.673382163378983370803370643371913374900.16
210.743385583387943386760.05
单位质量响应值RSD%判断
31629.8031534.080.22数据可信
供试品溶液-2024010612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%
5min1242364-24236468.79171.793.5068.7971.793.50
2250715-25071571.16171.16
3249711-24971170.87670.88
4268534-26853476.21976.22
5249984-24998470.95470.95
6256207-25620772.72072.72
10min1298404-29840484.69787.643.4984.8587.803.48
2304620-30462086.46186.62
3300846-30084685.39085.55
4327464-32746492.94593.11
5314730-31473089.33189.49
6306563-30656387.01387.17
15min1321954-32195491.38193.623.0991.7293.973.09
2328344-32834493.19593.55
3325085-32508592.27092.62
4347992-34799298.77299.15
5334546-33454694.95595.31
6321042-32104291.12391.48
20min1334638-33463894.98296.042.4995.5396.602.49
2338226-33822696.00096.56
3334768-33476895.01895.57
4353486-353486100.331100.93
5340333-34033396.59897.17
6328680-32868093.29093.85
30min1340083-34008396.52797.082.7397.2897.862.73
2342202-34220297.12897.90
3340447-34044796.63097.39
4357015-357015101.333102.15
5344560-34456097.79898.58
6327949-32794993.08393.85
45min1339736-33973696.42997.272.9197.4098.262.91
2344453-34445397.76798.75
3340770-34077096.72297.70
4358422-358422101.732102.78
5345290-34529098.00599.00
6327632-32763292.99393.96
60min1339239-33923996.28797.232.9197.4798.442.91
2343480-34348097.49198.70
3340374-34037496.61097.80
4358544-358544101.767103.04
5345662-34566298.11199.33
6327989-32798993.09494.27
极限1340021-34002196.50997.262.8497.9198.682.84
2342706-34270697.27298.69
3340982-34098296.78298.19
4357653-357653101.514103.01
5346786-34678698.43099.86
6327823-32782393.04794.43
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%
110.673386903387813392393378733375823384330.21
210.743400343401603400970.03
单位质量响应值RSD%判断
31718.1831666.390.12数据可信
供试品溶液-2024010612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%
5min1248212-24821270.20671.493.5470.2171.493.54
2242472-24247268.58268.58
3268418-26841875.92175.92
4250543-25054370.86570.86
5256755-25675572.62272.62
6250169-25016970.75970.76
10min1304503-30450386.12787.423.4486.2887.573.44
2298940-29894084.55484.71
3301313-30131385.22585.39
4327304-32730492.57692.73
5315628-31562889.27489.44
6306658-30665886.73786.89
15min1328590-32859092.94093.312.8093.2993.662.79
2323072-32307291.37991.72
3345783-34578397.80398.16
4324620-32462091.81792.18
5321837-32183791.03091.39
6335445-33544594.87995.23
20min1338629-33862995.78095.522.6396.3396.082.62
2332665-33266594.09394.64
3353400-35340099.957100.53
4334035-33403594.48095.05
5327624-32762492.66793.23
6339871-33987196.13196.69
30min1342078-34207896.75596.652.7897.5297.422.78
2338693-33869395.79896.55
3357325-357325101.068101.87
4339844-33984496.12396.90
5328009-32800992.77693.54
6344307-34430797.38698.16
45min1342915-34291596.99296.912.6697.9797.902.65
2339765-33976596.10197.07
3357964-357964101.248102.27
4340720-34072096.37197.36
5329844-32984493.29594.27
6344617-34461797.47398.46
60min1342979-34297997.01096.812.9598.2198.012.93
2339211-33921195.94497.12
3358331-358331101.352102.60
4339880-33988096.13397.34
5327411-32741192.60793.79
6345786-34578697.80499.01
极限1341089-34108996.47596.912.8997.8998.332.88
2339714-33971496.08697.48
3358076-358076101.280102.75
4341326-34132696.54297.96
5328004-32800492.77494.16
6347568-34756898.30899.73
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%
110.673393213395953397173391553392693394110.07
210.743415683409583412630.13
单位质量响应值RSD%判断
31809.8431774.950.08数据可信
供试品溶液-JPS6768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%
5min1270568-27056876.28874.536.1676.2974.536.16
2232737-23273765.62165.62
3262216-26221673.93373.93
4269992-26999276.12576.13
5272811-27281176.92076.92
6277605-27760578.27278.27
10min1310716-31071687.60888.551.1887.7888.711.18
2315398-31539888.92889.07
3310483-31048387.54287.71
4311800-31180087.91388.08
5316035-31603589.10789.28
6319856-31985690.18590.36
15min1326465-32646592.04892.810.8992.4193.180.89
2331896-33189693.58093.92
3326753-32675392.12992.49
4327339-32733992.29592.66
5329152-32915292.80693.17
6333472-33347294.02494.40
20min1334396-33439694.28494.930.7994.8595.500.78
2338648-33864895.48396.03
3334247-33424794.24294.81
4335210-33521094.51495.08
5336730-33673094.94295.52
6340852-34085296.10596.69
30min1338165-33816595.34796.341.0396.1397.121.02
2345291-34529197.35698.12
3337834-33783495.25496.03
4340617-34061796.03896.82
5342080-34208096.45197.24
6346070-34607097.57698.37
45min1340959-34095996.13596.940.9697.1397.940.95
2346565-34656597.71598.70
3341685-34168596.34097.32
4340847-34084796.10397.10
5344117-34411797.02598.03
6348743-34874398.33099.34
60min1339833-33983395.81796.851.1397.0298.061.12
2347318-34731897.92899.12
3339787-33978795.80497.00
4341012-34101296.15097.36
5344546-34454697.14698.36
6348536-34853698.27199.50
极限1342928-34292896.69097.601.1298.1199.021.12
2348926-34892698.38199.80
3342190-34219096.48297.89
4343972-34397296.98498.40
5346823-34682397.78899.22
6352125-35212599.283100.73
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%
110.673376253384283395323394543393613388800.25
210.743405253403023404140.05
单位质量响应值RSD%判断
31760.0731695.900.15数据可信
供试品溶液-JPS6768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%
5min1278542-27854278.69677.481.8778.7077.481.87
2282674-28267479.86379.86
3270748-27074876.49476.49
4271049-27104976.57976.58
5270951-27095176.55176.55
6271500-27150076.70676.71
10min1316881-31688189.52789.521.1889.7089.691.18
2323640-32364091.43791.61
3312465-31246588.28088.45
4316642-31664289.46089.63
5314800-31480088.93989.11
6316694-31669489.47589.65
15min1331643-33164393.69893.871.1494.0794.241.14
2338956-33895695.76496.14
3327425-32742592.50692.87
4332141-33214193.83994.21
5330611-33061193.40693.77
6332824-33282494.03294.40
20min1337385-33738595.32095.831.0795.9096.411.07
2344751-34475197.40197.99
3333879-33387994.33094.90
4340918-34091896.31896.90
5339170-33917095.82596.40
6339086-33908695.80196.38
30min1341890-34189096.59397.201.1897.3997.991.18
2350567-35056799.04599.85
3338633-33863395.67396.45
4342990-34299096.90497.70
5344070-34407097.20998.00
6346089-34608997.77998.57
45min1343218-34321896.96897.521.0297.9898.531.02
2351287-35128799.248100.28
3340992-34099296.33997.33
4344167-34416797.23698.24
5344922-34492297.45098.45
6346427-34642797.87598.88
60min1344339-34433997.28598.021.3998.5199.241.38
2351751-35175199.379100.63
3341258-34125896.41597.62
4344666-34466697.37798.60
5345855-34585597.71398.93
6353765-35376599.948101.17
极限1346100-34610097.78398.291.0999.2299.731.09
2353562-35356299.891101.36
3342431-34243196.74698.17
4346568-34656897.91599.35
5348834-34883498.55599.99
6349906-34990698.858100.31
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