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%
19.873122753120763124293119273120953121600.07
29.963129123129893129500.02
单位质量响应值RSD%判断
31627.1531420.680.47数据可信
长期24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%
5min1265221-26522175.41871.307.8075.4271.307.80
2250932-25093271.35571.35
3273291-27329177.71377.71
4216286-21628661.50361.50
5249922-24992271.06771.07
6248876-24887670.77070.77
10min1307676-30767687.49084.484.0587.6684.644.06
2291115-29111582.78182.94
3308546-30854687.73887.91
4276634-27663478.66378.80
5302057-30205785.89286.05
6296427-29642784.29284.45
15min1324263-32426392.20790.371.9892.5790.721.99
2314683-31468389.48389.83
3323354-32335491.94892.32
4307993-30799387.58087.89
5321296-32129691.36391.71
6315335-31533589.66890.01
20min1333447-33344794.81993.521.0695.3994.061.07
2327861-32786193.23093.77
3330860-33086094.08394.65
4326037-32603792.71193.22
5330854-33085494.08194.63
6324195-32419592.18892.73
30min1342036-34203697.26196.140.9398.0496.900.93
2338303-33830396.19996.95
3338009-33800996.11696.90
4338326-33832696.20696.92
5339431-33943196.52097.28
6332493-33249394.54795.30
45min1347161-34716198.71897.530.9499.7198.500.94
2342569-34256997.41298.37
3343295-34329597.61998.61
4342956-34295697.52298.45
5344495-34449597.96098.94
6337397-33739795.94296.90
60min1348895-34889599.21198.070.86100.4299.260.86
2344702-34470298.01999.20
3344835-34483598.05799.27
4344744-34474498.03199.17
5346310-34631098.47699.67
6339897-33989796.65397.82
极限1349996-34999699.52498.560.73100.9699.970.74
2344859-34485998.06499.46
3347099-34709998.701100.13
4347546-34754698.828100.19
5347497-34749798.814100.23
6342678-34267897.44398.83
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%
19.873120833126933124763121033124693123650.09
29.963135983132383134180.09
单位质量响应值RSD%判断
31647.9231467.670.41数据可信
长期24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%
5min1253000-25300071.86573.883.3071.8773.883.30
2266785-26678575.78175.78
3271046-27104676.99176.99
4263761-26376174.92274.92
5257477-25747773.13773.14
6248569-24856970.60770.61
10min1298400-29840084.76185.481.3184.9285.651.31
2303610-30361086.24186.41
3306721-30672187.12587.30
4300708-30070885.41785.58
5300706-30070685.41685.58
6295506-29550683.93984.10
15min1318479-31847990.46590.450.8890.8190.800.89
2319113-31911390.64591.00
3323309-32330991.83792.20
4316542-31654289.91590.27
5318013-31801390.33290.68
6315109-31510989.50889.85
20min1328379-32837993.27792.940.7993.8393.500.79
2326468-32646892.73493.30
3331764-33176494.23894.81
4324720-32472092.23892.79
5326632-32663292.78193.33
6325270-32527092.39492.94
30min1337323-33732395.81795.340.6496.5796.100.64
2335911-33591195.41696.18
3338643-33864396.19296.97
4332758-33275894.52195.28
5335102-33510295.18795.95
6334120-33412094.90895.66
45min1342649-34264997.33096.690.9098.3097.670.90
2340299-34029996.66397.64
3344617-34461797.88998.88
4335823-33582395.39196.36
5338892-33889296.26397.23
6340193-34019396.63397.59
60min1343818-34381897.66297.050.8498.8598.240.84
2340659-34065996.76597.96
3345911-34591198.25799.47
4337648-33764895.91097.09
5341085-34108596.88698.07
6340772-34077296.79797.97
极限1345118-34511898.03297.360.8999.4398.770.89
2342993-34299397.42898.84
3346624-34662498.45999.89
4337839-33783995.96497.36
5341902-34190297.11898.52
6342144-34214497.18798.58
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%
19.873120663120703121433120403122213121080.03
29.963123363121343122350.05
单位质量响应值RSD%判断
31621.8831348.900.62数据可信
长期24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%
5min1260464-26046474.15672.733.8274.1672.733.82
2247925-24792570.58670.59
3239295-23929568.12968.13
4259800-25980073.96773.97
5264969-26496975.43975.44
6260215-26021574.08674.09
10min1306470-30647087.25586.091.8987.4286.261.90
2299840-29984085.36785.52
3292185-29218583.18883.34
4304696-30469686.75086.91
5307824-30782487.64087.81
6303335-30333586.36286.53
15min1323676-32367692.15391.460.8492.5191.820.85
2319725-31972591.02991.38
3317057-31705790.26990.61
4322329-32232991.77092.13
5324175-32417592.29592.66
6320562-32056291.26791.62
20min1333214-33321494.86994.660.8195.4395.220.82
2331544-33154494.39494.94
3330229-33022994.01994.56
4333424-33342494.92995.49
5336955-33695595.93496.50
6329544-32954493.82494.38
30min1341070-34107097.10697.120.6897.8897.890.69
2340081-34008196.82497.58
3339263-33926396.59197.34
4342470-34247097.50498.28
5345012-34501298.22899.01
6338837-33883796.47097.24
45min1345959-34595998.49898.520.5399.4999.510.53
2346447-34644798.63799.61
3345100-34510098.25399.21
4346039-34603998.52099.51
5349128-34912899.400100.40
6343624-34362497.83398.82
60min1347521-34752198.94298.910.56100.15100.110.57
2346298-34629898.59499.79
3347043-34704398.80699.98
4347482-34748298.931100.14
5350940-35094099.916101.14
6345211-34521198.28599.48
极限1348491-34849199.21899.230.56100.65100.650.57
2348018-34801899.084100.50
3348242-34824299.148100.55
4348307-34830799.166100.59
5352031-352031100.226101.67
6346015-34601598.51499.93
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