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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
1 15.174903454898604903124898994891994899230.10
2 15.124896974892254894610.07
单位质量响应值RSD%判断
32295.5232371.760.17数据可信
供试品溶液-2024122821批-pH6.8(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1332708-33270861.49258.515.0861.4958.515.08
2308603-30860357.03757.04
3331722-33172261.31061.31
4306206-30620656.59456.59
5326665-32666560.37560.38
6293593-29359354.26354.26
10min1438966-43896681.13181.420.6981.2381.520.69
2440496-44049681.41481.51
3446321-44632182.49182.59
4440673-44067381.44781.54
5438995-43899581.13681.24
6437839-43783980.92381.01
15min1466556-46655686.23087.370.8086.4787.600.79
2473507-47350787.51587.75
3478183-47818388.37988.62
4472303-47230387.29387.52
5473667-47366787.54587.78
6472093-47209387.25487.48
20min1490193-49019390.59990.290.5190.9890.670.51
2486522-48652289.92190.30
3491639-49163990.86691.25
4485412-48541289.71590.09
5490175-49017590.59690.98
6487220-48722090.05090.42
30min1494860-49486091.46292.490.6591.9993.020.65
2498982-49898292.22392.75
3501984-50198492.77893.32
4500093-50009392.42992.95
5503340-50334093.02993.56
6503380-50338093.03693.56
45min1502476-50247692.86994.140.7893.5594.830.78
2507980-50798093.88794.57
3509672-50967294.19994.89
4509801-50980194.22394.90
5513557-51355794.91795.61
6512768-51276894.77195.45
60min1507400-50740093.77994.850.7494.6295.690.73
2511264-51126494.49395.33
3512947-51294794.80595.65
4513207-51320794.85395.69
5518114-51811495.76096.61
6516250-51625095.41596.25
极限1510666-51066694.38395.931.3295.3896.931.31
2517663-51766395.67696.67
3514537-51453795.09896.11
4521519-52151996.38997.38
5530685-53068598.08399.09
6519211-51921195.96296.96
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
1 15.174903224905124902914895794914574904320.14
2 15.124889804890904890350.02
单位质量响应值RSD%判断
32329.0732343.580.04数据可信
供试品溶液-2024122921批-pH6.8(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1324264-32426459.92662.902.8359.9362.902.83
2347991-34799164.31164.31
3334502-33450261.81961.82
4342069-34206963.21763.22
5342981-34298163.38663.39
6350420-35042064.76064.76
10min1446644-44664482.54383.611.2682.6483.721.26
2449519-44951983.07583.18
3446436-44643682.50582.61
4456445-45644584.35584.46
5455478-45547884.17684.28
6460000-46000085.01285.12
15min1477416-47741688.23088.781.1288.4789.021.12
2475011-47501187.78688.03
3475978-47597887.96488.20
4484375-48437589.51689.76
5480751-48075188.84689.09
6488736-48873690.32290.57
20min1490963-49096390.73490.941.0491.1291.341.04
2484107-48410789.46789.86
3489666-48966690.49490.88
4495887-49588791.64492.04
5493309-49330991.16791.56
6498602-49860292.14592.55
30min1505065-50506593.34093.370.9593.8893.920.95
2497501-49750191.94292.48
3502357-50235792.83993.38
4508751-50875194.02194.57
5507069-50706993.71094.26
6510730-51073094.38794.94
45min1511426-51142694.51594.620.9295.2195.320.92
2504600-50460093.25493.95
3508835-50883594.03794.73
4514270-51427095.04195.75
5516345-51634595.42496.13
6516524-51652495.45896.17
60min1514459-51445995.07695.060.9195.9295.920.91
2507221-50722193.73894.59
3511296-51129694.49195.34
4515851-51585195.33396.20
5517057-51705795.55696.42
6520516-52051696.19597.07
极限1518264-51826495.77995.730.5096.7996.740.51
2513893-51389394.97195.98
3516565-51656595.46596.47
4518250-51825095.77796.80
5519368-51936895.98397.00
6521521-52152196.38197.41
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
1 15.174896324899654904194900764893264898840.09
2 15.124905494898904902200.10
单位质量响应值RSD%判断
32292.9532421.960.29数据可信
供试品溶液-2024123021批-pH6.8(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1325049-32504960.03362.003.9060.0362.003.91
2351227-35122764.86764.87
3317744-31774458.68358.68
4344575-34457563.63963.64
5331046-33104661.14061.14
6344564-34456463.63763.64
10min1439613-43961381.19183.081.7081.2983.181.70
2457984-45798484.58484.69
3446220-44622082.41182.51
4451290-45129083.34883.45
5445153-44515382.21482.32
6458836-45883684.74184.85
15min1469079-46907986.63388.721.3086.8788.961.30
2485384-48538489.64489.89
3479527-47952788.56388.80
4480566-48056688.75589.00
5481070-48107088.84889.09
6486598-48659889.86990.12
20min1482511-48251189.11491.311.3589.4991.701.35
2502193-50219392.74993.15
3492911-49291191.03591.42
4494703-49470391.36691.76
5495847-49584791.57791.96
6498179-49817992.00892.40
30min1495634-49563491.53893.751.3792.0794.301.37
2516052-51605295.30895.86
3505367-50536793.33593.87
4507171-50717193.66894.21
5510360-51036094.25794.80
6511181-51118194.40994.96
45min1506030-50603093.45895.431.1994.1496.121.19
2524079-52407996.79197.50
3514919-51491995.09995.79
4516327-51632795.35996.06
5519968-51996896.03296.73
6518792-51879295.81596.52
60min1509837-50983794.16196.141.2195.0097.001.21
2528552-52855297.61798.49
3518494-51849495.75996.61
4520288-52028896.09196.95
5523552-52355296.69497.55
6522501-52250196.50097.37
极限1516353-51635395.36496.780.9996.3697.800.99
2531724-53172498.20399.24
3522184-52218496.44197.45
4522485-52248596.49797.52
5527004-52700497.33198.35
6524371-52437196.84597.87
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