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%
115.251748111740371751821746221742641745830.26
215.331738761740961739860.09
单位质量响应值RSD%判断
11448.0711349.380.62数据可信
供试品溶液-2025081121批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min134486-3448618.05918.091.9718.0618.091.95
233936-3393617.77017.77
334310-3431017.96617.97
434157-3415717.88617.89
534498-3449818.06518.06
635852-3585218.77418.77
60min158383-5838330.57230.840.6830.6030.870.68
259216-5921631.00831.04
358545-5854530.65730.69
458721-5872130.74930.78
559185-5918530.99231.02
659327-5932731.06631.10
120min194809-9480949.64649.670.4449.7349.750.44
295100-9510049.79949.88
394384-9438449.42449.50
494350-9435049.40649.49
595104-9510449.80149.88
695350-9535049.93050.01
240min1139317-13931772.95372.670.5773.1272.840.57
2139522-13952273.06073.22
3137488-13748871.99572.16
4138283-13828372.41272.57
5139374-13937472.98373.15
6138684-13868472.62272.79
360min1166495-16649587.18586.010.9687.4786.290.96
2165027-16502786.41686.70
3161767-16176784.70984.99
4163567-16356785.65185.94
5164391-16439186.08386.37
6164229-16422985.99886.29
480min1184225-18422596.46994.231.3896.9094.661.38
2180755-18075594.65295.08
3176863-17686392.61493.04
4178492-17849293.46793.89
5179873-17987394.19094.62
6179524-17952494.00794.44
600min1188588-18858898.75497.780.7099.3598.370.70
2187250-18725098.05398.64
3184719-18471996.72897.31
4185955-18595597.37597.96
5187123-18712397.98698.57
6186765-18676597.79998.39
720min1192273-192273100.68399.700.57101.44100.450.57
2190655-19065599.836100.59
3189869-18986999.424100.16
4189649-18964999.309100.05
5190676-19067699.847100.60
6189305-18930599.12999.88
960min1194006-194006101.591100.260.85102.51101.170.85
2191729-191729100.398101.32
3188951-18895198.94499.85
4190944-19094499.987100.90
5191752-191752100.410101.33
6191370-191370100.210101.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1194340-194340101.766100.270.97102.86101.350.97
2192049-192049100.566101.65
3189023-18902398.981100.05
4189959-18995999.472100.55
5191869-191869100.472101.56
6191664-191664100.364101.45
1440min1194136-194136101.659100.271.00102.92101.521.00
2191489-191489100.273101.53
3188574-18857498.74699.98
4190200-19020099.598100.84
5192170-192170100.629101.88
6192299-192299100.697101.95
极限1194089-194089101.634100.491.09103.07101.901.08
2192155-192155100.621102.04
3189078-18907899.010100.41
4190364-19036499.684101.09
5194372-194372101.782103.20
6191331-191331100.190101.61
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%
115.251734451739421737251736841740701737730.14
215.331741091743831742460.12
单位质量响应值RSD%判断
11394.9511366.340.18数据可信
供试品溶液-2025081221批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min133459-3345917.54817.634.3917.5517.634.38
233394-3339417.51417.51
336350-3635019.06419.06
433799-3379917.72717.73
532126-3212616.84916.85
632586-3258617.09017.09
60min157240-5724030.02129.673.0730.0529.703.07
254835-5483528.75928.79
359404-5940431.15631.19
457265-5726530.03430.06
555229-5522928.96628.99
655460-5546029.08729.12
120min191769-9176948.13047.942.1848.2148.022.17
289499-8949946.94047.02
394722-9472249.67949.76
492404-9240448.46348.54
590090-9009047.25047.33
689919-8991947.16047.24
240min1136828-13682871.76270.961.1171.9271.121.11
2134331-13433170.45370.61
3137449-13744972.08872.25
4134754-13475470.67470.83
5134804-13480470.70170.86
6133635-13363570.08870.24
360min1164376-16437686.21084.850.9786.4985.120.97
2162185-16218585.06185.33
3162326-16232685.13585.42
4160268-16026884.05684.33
5161226-16122684.55884.83
6160265-16026584.05484.33
480min1181576-18157695.23193.141.3595.6593.561.35
2178882-17888293.81894.23
3177551-17755193.12093.55
4175114-17511491.84292.26
5176942-17694292.80193.21
6175477-17547792.03292.44
600min1190113-19011399.70997.471.45100.2998.041.45
2187403-18740398.28798.86
3185846-18584697.47198.05
4182876-18287695.91396.48
5185572-18557297.32797.90
6183250-18325096.10996.68
720min1194122-194122101.81199.301.45102.56100.041.45
2190763-190763100.050100.78
3188530-18853098.87899.62
4186396-18639697.75998.49
5188379-18837998.79999.53
6187814-18781498.50399.23
960min1196268-196268102.937100.371.59103.85101.271.59
2193637-193637101.557102.46
3190249-19024999.780100.69
4188262-18826298.73899.63
5190881-190881100.111101.01
6188924-18892499.08599.98
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1198122-198122103.909100.871.77105.00101.941.76
2194365-194365101.939103.01
3190760-190760100.048101.13
4188629-18862998.93099.99
5191606-191606100.492101.55
6190507-19050799.915100.97
1440min1199065-199065104.404101.461.96105.67102.701.95
2195534-195534102.552103.79
3190299-19029999.806101.05
4189029-18902999.140100.36
5195139-195139102.345103.57
6191631-191631100.505101.73
极限1199739-199739104.757101.142.16106.19102.542.14
2195274-195274102.415103.83
3190166-19016699.736101.15
4187925-18792598.56199.95
5191980-191980100.688102.09
6191955-191955100.675102.06
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%
115.251741891740471737601741511742111740720.11
215.331736441740231738340.16
单位质量响应值RSD%判断
11414.5611339.470.47数据可信
供试品溶液-2025081321批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min135398-3539818.57117.874.3918.5717.864.38
236052-3605218.91418.91
332677-3267717.14417.14
433161-3316117.39817.40
534546-3454618.12418.12
632497-3249717.04917.05
60min159343-5934331.13430.452.6231.1630.482.62
260218-6021831.59331.62
357208-5720830.01430.04
457198-5719830.00930.04
558132-5813230.49930.53
656123-5612329.44529.47
120min196009-9600950.37049.241.8350.4549.321.84
295255-9525549.97550.06
393044-9304448.81548.89
493897-9389749.26249.34
593843-9384349.23449.32
691118-9111847.80447.88
240min1139111-13911172.98472.650.6673.1572.810.66
2138971-13897172.91073.08
3138593-13859372.71272.87
4139035-13903572.94473.10
5138371-13837172.59572.76
6136715-13671571.72771.88
360min1165825-16582586.99986.780.4187.2987.060.41
2165555-16555586.85787.15
3165682-16568286.92487.20
4166167-16616787.17887.46
5164748-16474886.43486.72
6164430-16443086.26786.54
480min1182080-18208095.52795.260.4195.9695.690.41
2181410-18141095.17595.61
3181352-18135295.14595.57
4182226-18222695.60496.03
5180257-18025794.57195.00
6182076-18207695.52595.95
600min1189999-18999999.68299.750.43100.27100.340.43
2190524-19052499.957100.55
3190954-190954100.183100.77
4190451-19045199.919100.51
5188608-18860898.95299.54
6190288-19028899.833100.41
720min1194522-194522102.055101.320.59102.81102.080.59
2193739-193739101.644102.40
3192221-192221100.847101.60
4193322-193322101.425102.18
5191390-191390100.411101.16
6193581-193581101.561102.31
960min1196439-196439103.060102.040.87103.99102.960.87
2195471-195471102.552103.48
3193514-193514101.526102.45
4195008-195008102.310103.23
5191664-191664100.555101.47
6194899-194899102.252103.17
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1196729-196729103.212102.150.88104.31103.240.88
2196189-196189102.929104.03
3193528-193528101.533102.62
4194656-194656102.125103.22
5192087-192087100.777101.86
6194992-194992102.301103.39
1440min1197080-197080103.397102.060.97104.67103.330.96
2195351-195351102.489103.76
3193175-193175101.348102.61
4194959-194959102.284103.55
5191662-191662100.554101.81
6194989-194989102.300103.56
极限1196582-196582103.135101.820.97104.58103.260.97
2194554-194554102.071103.51
3192964-192964101.237102.66
4194804-194804102.202103.64
5191052-191052100.234101.66
6194523-194523102.055103.48
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