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%
110.033232313229823229033227943229193229660.06
210.133257253255833256540.04
单位质量响应值RSD%判断
32200.0032147.480.12数据可信
长期3月-供试品溶液-2024010511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%
5min1210666-21066658.69467.096.8758.6967.086.87
2255784-25578471.26571.26
3234896-23489665.44565.44
4241979-24197967.41867.42
5251223-25122369.99469.99
6250155-25015569.69669.70
10min1275129-27512976.65482.844.0076.7882.994.01
2306835-30683585.48885.65
3294758-29475882.12382.27
4297545-29754582.90083.05
5304718-30471884.89885.05
6305090-30509085.00285.16
15min1303081-30308184.44288.902.7384.7489.232.74
2323611-32361190.16290.51
3316623-31662388.21588.54
4319282-31928288.95689.29
5324779-32477990.48790.83
6327049-32704991.12091.46
20min1318965-31896588.86891.771.7889.3692.301.79
2330600-33060092.10992.66
3327980-32798091.37991.90
4329267-32926791.73892.27
5333919-33391993.03493.58
6335566-33556693.49394.04
30min1334352-33435293.15594.461.2093.8495.201.21
2338833-33883394.40395.16
3335574-33557493.49594.22
4337781-33778194.11094.85
5343910-34391095.81896.57
6343791-34379195.78496.54
45min1340365-34036594.83095.690.9995.7296.641.01
2341566-34156695.16596.13
3340805-34080594.95395.89
4342586-34258695.44996.39
5347294-34729496.76097.73
6348164-34816497.00397.97
60min1341617-34161795.17996.181.0196.2897.341.02
2342793-34279395.50696.68
3344688-34468896.03497.18
4343255-34325595.63596.79
5349701-34970197.43198.61
6349302-34930297.32098.50
极限1343728-34372895.76796.611.1497.0897.981.14
2344240-34424095.91097.30
3344593-34459396.00897.37
4344481-34448195.97797.35
5352953-35295398.33799.73
6350449-35044997.63999.04
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%
110.033232173238863235553232343235103234800.09
210.133246233243063244640.07
单位质量响应值RSD%判断
32251.2532030.010.49数据可信
长期3月-供试品溶液-2024010611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%
5min1236633-23663365.99864.195.9266.0064.195.92
2214952-21495259.95159.95
3212497-21249759.26659.27
4247093-24709368.91568.91
5232640-23264064.88464.88
6237155-23715566.14366.14
10min1292859-29285981.67981.593.6181.8381.733.61
2288612-28861280.49580.63
3275841-27584176.93377.06
4308285-30828585.98286.13
5296124-29612482.59082.73
6293510-29351081.86182.01
15min1312390-31239087.12688.012.7487.4588.342.75
2316264-31626488.20788.52
3302571-30257184.38884.69
4329403-32940391.87192.22
5315662-31566288.03988.37
6317108-31710888.44288.77
20min1321412-32141289.64391.182.4490.1691.702.44
2331050-33105092.33192.84
3316196-31619688.18888.68
4339233-33923394.61395.16
5325604-32560490.81291.34
6328021-32802191.48692.01
30min1329253-32925391.83093.962.4092.5594.682.39
2344023-34402395.94996.66
3327483-32748391.33692.02
4347703-34770396.97597.73
5334326-33432693.24493.97
6338657-33865794.45295.18
45min1333861-33386193.11595.452.4094.0496.382.40
2350686-35068697.80798.73
3333396-33339692.98593.87
4352410-35241098.28899.26
5339108-33910894.57895.51
6343907-34390795.91796.86
60min1334578-33457893.31595.772.3994.4596.922.38
2352021-35202198.18099.32
3334386-33438693.26194.36
4352999-35299998.45299.64
5341063-34106395.12396.27
6345323-34532396.31197.46
极限1336770-33677093.92696.052.1995.2797.412.19
2352400-35240098.28599.65
3335452-33545293.55894.86
4352576-35257698.33499.75
5341864-34186495.34796.70
6347292-34729296.86198.23
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%
110.033241003242713241543242403235543240640.10
210.133231033236243233640.12
单位质量响应值RSD%判断
32309.4731921.420.86数据可信
长期3月-供试品溶液-2024010612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%
5min1225852-22585263.04266.776.3963.0466.776.39
2256638-25663871.63571.63
3257366-25736671.83871.84
4235395-23539565.70565.71
5220725-22072561.61161.61
6239337-23933766.80666.81
10min1282442-28244278.83881.964.0978.9882.114.09
2306205-30620585.47085.63
3304419-30441984.97285.13
4291838-29183881.46081.61
5276976-27697677.31277.45
6299857-29985783.69983.85
15min1308143-30814386.01187.852.5086.3388.182.51
2322825-32282590.11090.46
3320735-32073589.52689.87
4310486-31048686.66586.99
5304761-30476185.06785.38
6321511-32151189.74390.08
20min1322191-32219189.93390.861.8090.4491.391.81
2330550-33055092.26692.82
3328528-32852891.70192.25
4320267-32026789.39689.92
5318805-31880588.98789.49
6332796-33279692.89393.43
30min1334598-33459893.39693.891.3694.1094.621.36
2338661-33866194.53095.28
3337513-33751394.20994.96
4329747-32974792.04292.76
5334520-33452093.37494.07
6343180-34318095.79196.53
45min1339669-33966994.81195.211.3795.7396.141.37
2343797-34379795.96396.93
3341645-34164595.36396.32
4333498-33349893.08994.01
5340441-34044195.02795.93
6347463-34746396.98797.94
60min1340610-34061095.07495.471.3896.2096.611.39
2344264-34426496.09497.27
3342710-34271095.66096.83
4334480-33448093.36394.49
5341226-34122695.24696.36
6348801-34880197.36098.53
极限1342428-34242895.58195.661.3496.9297.021.34
2344703-34470396.21697.61
3342973-34297395.73397.12
4335415-33541593.62494.96
5341297-34129795.26696.59
6349453-34945397.54298.93
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