乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48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%
115.081745841733981724791736611737811735810.44
215.021740901737531739220.14
单位质量响应值RSD%判断
11510.6811579.360.43数据可信
供试品溶液-js2M批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min1152674-15267478.93385.3010.7678.9385.3010.76
2155522-15552280.40680.41
3188059-18805997.22897.23
4167655-16765586.67986.68
5143195-14319574.03374.03
6182806-18280694.51294.51
60min1169423-16942387.59395.265.3887.7295.405.39
2177282-17728291.65691.79
3192760-19276099.65899.82
4194375-194375100.493100.64
5181193-18119393.67893.80
6190446-19044698.46298.62
120min1182178-18217894.18799.013.2894.4699.313.29
2189269-18926997.85398.14
3194163-194163100.384100.71
4200967-200967103.901104.21
5189223-18922397.83098.11
6193245-19324599.909100.23
240min1193608-193608100.097100.211.91100.53100.681.92
2192520-19252099.53499.98
3195200-195200100.920101.42
4200231-200231103.521104.01
5189286-18928697.86298.30
6192119-19211999.32799.81
360min1195729-195729101.193101.201.80101.79101.841.80
2194429-194429100.521101.14
3196817-196817101.756102.42
4201843-201843104.354105.01
5191331-19133198.91999.53
6194333-194333100.471101.13
480min1195482-195482101.066100.832.08101.84101.632.08
2192769-19276999.663100.45
3196499-196499101.591102.42
4201891-201891104.379105.21
5190093-19009398.27999.05
6193411-19341199.995100.82
600min1195202-195202100.921100.581.72101.86101.551.73
2192774-19277499.665100.61
3194537-194537100.577101.58
4200387-200387103.601104.61
5190328-19032898.40199.34
6194002-194002100.300101.29
720min1194315-194315100.462100.241.95101.57101.381.96
2192799-19279999.678100.79
3194562-194562100.590101.76
4200073-200073103.439104.62
5188332-18833297.36998.47
6193214-19321499.893101.05
960min1194030-194030100.31599.941.93101.59101.241.94
2190789-19078998.63999.92
3193697-193697100.143101.48
4199590-199590103.189104.54
5188527-18852797.47098.73
6193182-19318299.876101.20
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1194099-194099100.350100.152.00101.79101.622.00
2191794-19179499.159100.60
3194711-194711100.667102.17
4199880-199880103.339104.86
5188078-18807897.23898.66
6193661-193661100.124101.61
1440min1192853-19285399.70699.461.53101.31101.091.55
2191049-19104998.774100.38
3193260-19326099.917101.59
4197122-197122101.913103.61
5188194-18819497.29898.88
6191722-19172299.122100.78
极限1192907-19290799.734100.032.66101.51101.832.65
2189996-18999698.229100.01
3192182-19218299.359101.20
4202135-202135104.505106.37
5187491-18749196.93498.68
6196135-196135101.403103.22
乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48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%
115.081741501737751743101737811739401739910.14
215.021743631741841742740.08
单位质量响应值RSD%判断
11537.8611602.800.40数据可信
供试品溶液-js2M批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min133810-3381017.44216.385.0817.4416.385.09
229811-2981115.37915.38
333605-3360517.33617.34
430693-3069315.83415.83
531213-3121316.10216.10
631376-3137616.18616.19
60min155350-5535028.55427.162.6928.5827.192.69
251729-5172926.68626.71
352365-5236527.01427.04
451653-5165326.64726.67
551831-5183126.73826.77
652998-5299827.34027.37
120min190654-9065446.76645.072.2846.8445.142.28
288381-8838145.59445.66
385896-8589644.31244.39
485917-8591744.32244.39
585511-8551144.11344.18
687804-8780445.29645.37
240min1133191-13319168.71067.331.6268.8667.481.62
2132645-13264568.42868.57
3128767-12876766.42866.58
4129414-12941466.76166.91
5128049-12804966.05766.20
6131047-13104767.60467.75
360min1158361-15836181.69580.201.4781.9680.461.47
2156617-15661780.79581.05
3152442-15244278.64178.90
4155320-15532080.12680.38
5153176-15317679.02079.27
6156866-15686680.92381.18
480min1171676-17167688.56387.391.4488.9787.791.43
2169565-16956587.47487.87
3164803-16480385.01885.41
4169254-16925487.31487.70
5170180-17018087.79288.18
6170981-17098188.20588.60
600min1179644-17964492.67491.471.6593.2392.021.65
2178736-17873692.20592.75
3172029-17202988.74689.28
4177239-17723991.43391.97
5176404-17640491.00291.54
6179867-17986792.78993.33
720min1184920-18492095.39694.061.5096.1094.751.50
2183111-18311194.46295.16
3177462-17746291.54892.23
4182559-18255994.17894.87
5181318-18131893.53794.22
6184601-18460195.23195.93
960min1190201-19020198.12096.991.6698.9997.841.65
2190354-19035498.19999.05
3182332-18233294.06194.89
4187962-18796296.96597.81
5187037-18703796.48897.33
6190183-19018398.11198.97
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1193934-193934100.04698.841.70101.0899.851.69
2193278-19327899.707100.72
3185328-18532895.60696.59
4191808-19180898.94999.95
5191430-19143098.75499.76
6193796-19379699.975100.99
1440min1194817-194817100.50199.031.51101.70100.201.50
2193211-19321199.673100.85
3186578-18657896.25197.40
4191732-19173298.910100.08
5191795-19179598.942100.11
6193628-19362899.888101.07
极限1194081-194081100.12298.731.49101.49100.071.49
2192923-19292399.524100.87
3186236-18623696.07597.38
4191314-19131498.694100.03
5190495-19049598.27299.60
6193231-19323199.683101.04
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