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%
114.801710931707941714231710891712971711390.14
214.811707351706121706740.06
单位质量响应值RSD%判断
11563.4511524.240.25数据可信
供试品溶液-2025032321-bc1-js1M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%
30min138715-3871520.01820.256.4620.0220.256.47
242144-4214421.79121.79
339980-3998020.67220.67
434647-3464717.91417.91
540508-4050820.94520.94
638988-3898820.15920.16
60min170383-7038336.39235.887.9436.4335.927.94
275627-7562739.10339.14
368976-6897635.66435.70
459359-5935930.69230.72
569367-6936735.86735.90
672671-7267137.57537.61
120min1113127-11312758.49357.057.6958.5957.147.69
2117899-11789960.96061.06
3110348-11034857.05657.15
494448-9444848.83548.92
5109410-10941056.57156.67
6116762-11676260.37360.47
240min1163694-16369484.63981.724.1584.8381.914.16
2164133-16413384.86685.07
3157516-15751681.44581.63
4146201-14620175.59475.76
5156789-15678981.06981.26
6159995-15999582.72682.92
360min1189140-18914097.79694.813.0398.1395.133.03
2186527-18652796.44596.79
3181801-18180194.00194.33
4173766-17376689.84790.14
5181899-18189994.05294.38
6187009-18700996.69497.03
480min1197830-197830102.28999.641.61102.78100.121.62
2192838-19283899.708100.21
3190214-19021498.35198.83
4189025-18902597.73798.17
5192341-19234199.45199.93
6193992-193992100.305100.80
600min1199157-199157102.975100.881.32103.64101.531.33
2194405-194405100.518101.19
3192617-19261799.594100.24
4192256-19225699.407100.01
5196151-196151101.421102.07
6196011-196011101.349102.01
720min1199648-199648103.229101.291.17104.07102.111.17
2194477-194477100.556101.39
3193070-19307099.828100.64
4195106-195106100.881101.65
5197008-197008101.864102.68
6196110-196110101.400102.23
960min1198721-198721102.750100.921.28103.76101.911.26
2192443-19244399.504100.51
3192379-19237999.471100.45
4196350-196350101.524102.46
5196376-196376101.537102.52
6194836-194836100.741101.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1198888-198888102.836100.771.59104.02101.931.56
2191657-19165799.097100.27
3191534-19153499.034100.18
4197915-197915102.333103.44
5195230-195230100.945102.10
6194161-194161100.392101.56
1440min1198645-198645102.711100.361.49104.06101.681.47
2191127-19112798.823100.16
3191108-19110898.814100.12
4195059-195059100.856102.13
5195280-195280100.971102.29
6193375-19337599.986101.32
极限1197385-197385102.059100.401.18103.58101.881.17
2191587-19158799.061100.56
3191658-19165899.098100.57
4195301-195301100.982102.42
5195366-195366101.015102.51
6193735-193735100.172101.67
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%
114.801703411708991705911703811703301705080.15
214.811715431711241713340.18
单位质量响应值RSD%判断
11520.8111568.800.30数据可信
供试品溶液-2025032321-bc2-js1M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%
30min132497-3249716.80114.518.7316.8014.518.73
225239-2523913.04913.05
327119-2711914.02114.02
428205-2820514.58214.58
526914-2691413.91513.91
628467-2846714.71814.72
60min153085-5308527.44625.914.0827.4725.934.08
247147-4714724.37624.40
348843-4884325.25325.28
451205-5120526.47426.50
549722-4972225.70725.73
650657-5065726.19026.21
120min186813-8681344.88442.983.0644.9643.053.07
279227-7922740.96141.02
383146-8314642.98843.05
483466-8346643.15343.22
581799-8179942.29142.36
684370-8437043.62043.69
240min1127989-12798966.17263.842.3266.3263.982.32
2120504-12050462.30262.43
3123017-12301763.60163.74
4123286-12328663.74163.88
5120701-12070162.40462.54
6125368-12536864.81764.96
360min1154635-15463579.94877.591.9480.2177.841.95
2147852-14785276.44276.68
3149542-14954277.31577.56
4149625-14962577.35877.60
5146630-14663075.81076.05
6152141-15214178.65978.91
480min1168639-16863987.18985.141.6887.5885.521.69
2162358-16235883.94184.30
3164199-16419984.89385.27
4163899-16389984.73885.11
5161658-16165883.57983.95
6167352-16735286.52386.90
600min1177600-17760091.82289.911.4592.3690.431.45
2172286-17228689.07489.58
3173349-17334989.62490.14
4173078-17307889.48490.00
5170928-17092888.37288.88
6176198-17619891.09791.62
720min1183733-18373394.99393.351.4095.6894.021.39
2181520-18152093.84894.50
3180364-18036493.25193.91
4178524-17852492.29992.97
5176914-17691491.46792.12
6182312-18231294.25894.93
960min1190668-19066898.57896.761.0999.4397.591.10
2185745-18574596.03396.84
3186984-18698496.67397.49
4185987-18598796.15896.98
5185247-18524795.77596.58
6188338-18833897.37398.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1194154-194154100.38098.321.32101.3999.301.33
2188904-18890497.66698.63
3189812-18981298.13599.11
4189035-18903597.73498.71
5187140-18714096.75497.72
6191976-19197699.254100.25
1440min1196584-196584101.63799.471.33102.82100.611.34
2191582-19158299.051100.18
3191157-19115798.83199.97
4191811-19181199.169100.31
5189228-18922897.83498.96
6193942-193942100.271101.43
极限1196300-196300101.49099.181.37102.84100.491.38
2190535-19053598.50999.80
3191679-19167999.101100.41
4190356-19035698.41799.72
5188878-18887897.65398.94
6193226-19322699.901101.23
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%
114.801699501704541701151698381706771702070.21
214.811709371704141706760.22
单位质量响应值RSD%判断
11500.4711524.380.15数据可信
供试品溶液-2025032321-kd-30℃1M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%
30min128170-2817014.60514.674.7014.6114.674.71
227914-2791414.47214.47
329352-2935215.21815.22
427497-2749714.25614.26
526540-2654013.76013.76
630254-3025415.68615.69
60min150483-5048326.17426.412.6626.2026.442.66
250796-5079626.33626.36
351562-5156226.73326.76
450344-5034426.10226.13
549241-4924125.53025.55
653237-5323727.60227.63
120min180940-8094041.96543.142.5642.0343.202.56
283734-8373443.41343.48
384259-8425943.68543.76
484793-8479343.96244.03
580171-8017141.56641.63
685294-8529444.22244.29
240min1120660-12066062.55863.191.5062.7063.331.50
2121304-12130462.89263.03
3123229-12322963.89064.03
4122579-12257963.55363.69
5119237-11923761.82061.96
6124212-12421264.40064.55
360min1146985-14698576.20776.981.5276.4577.221.52
2148879-14887977.18977.43
3149854-14985477.69477.94
4149916-14991677.72677.97
5144647-14464774.99575.23
6150540-15054078.05078.30
480min1163063-16306384.54385.071.2784.9185.451.27
2164443-16444385.25885.63
3165557-16555785.83686.21
4164770-16477085.42885.80
5160462-16046283.19483.56
6166240-16624086.19086.57
600min1173287-17328789.84489.951.2190.3590.461.21
2173990-17399090.20890.72
3174020-17402090.22490.75
4174178-17417890.30590.82
5169607-16960787.93688.44
6175858-17585891.17691.70
720min1179441-17944193.03493.501.3893.6994.171.39
2181944-18194494.33295.00
3180563-18056393.61694.29
4181218-18121893.95594.62
5175907-17590791.20291.85
6183002-18300294.88095.56
960min1186624-18662496.75896.911.0697.5797.731.07
2187389-18738997.15597.98
3187979-18797997.46198.29
4187740-18774097.33798.16
5183103-18310394.93395.73
6188638-18863897.80298.64
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1190123-19012398.57298.861.3199.5599.841.31
2190643-19064398.84299.83
3192144-19214499.620100.61
4191482-19148299.277100.26
5186212-18621296.54597.50
6193477-193477100.311101.31
1440min1192136-19213699.61699.771.26100.76100.911.27
2192402-19240299.754100.90
3193891-193891100.526101.68
4193681-193681100.417101.57
5187851-18785197.39498.51
6194582-194582100.884102.05
极限1192733-19273399.92699.671.29101.23100.981.29
2192526-19252699.818101.13
3193456-193456100.300101.62
4193053-193053100.092101.41
5187357-18735797.13898.42
6194330-194330100.754102.09
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