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%
115.041740331738501743081748081740191742040.22
215.161740681745661743170.21
单位质量响应值RSD%判断
11582.7111498.480.52数据可信
供试品溶液-2025032321批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min127623-2762314.28714.334.0014.2914.334.01
226493-2649313.70213.70
328245-2824514.60914.61
428956-2895614.97614.98
528601-2860114.79314.79
626295-2629513.60013.60
60min148294-4829424.97825.103.0725.0025.123.08
246959-4695924.28824.31
349365-4936525.53225.56
450552-5055226.14626.17
549258-4925825.47725.50
646728-4672824.16824.19
120min178091-7809140.38940.471.6840.4540.541.68
278302-7830240.49840.56
379280-7928041.00441.07
478618-7861840.66240.73
579427-7942741.08041.15
675798-7579839.20339.27
240min1118950-11895061.52261.861.8361.6561.991.83
2118054-11805461.05861.19
3119515-11951561.81461.95
4122372-12237263.29263.43
5121906-12190663.05163.19
6116791-11679160.40560.53
360min1143920-14392074.43674.581.2774.6774.821.27
2142995-14299573.95874.19
3144181-14418174.57174.81
4144399-14439974.68474.93
5147507-14750776.29276.53
6142178-14217873.53573.76
480min1160284-16028482.90082.991.1483.2683.351.15
2159222-15922282.35182.71
3159641-15964182.56782.93
4161316-16131683.43483.80
5163670-16367084.65185.02
6158601-15860182.03082.38
600min1170776-17077688.32788.341.0088.8288.841.01
2170320-17032088.09188.58
3169640-16964087.73988.24
4170872-17087288.37688.88
5174025-17402590.00790.52
6169210-16921087.51788.00
720min1176919-17691991.50491.921.2292.1592.571.22
2177195-17719591.64792.29
3175808-17580890.92991.58
4179237-17923792.70393.36
5181325-18132593.78394.44
6175837-17583790.94491.58
960min1187711-18771197.08595.321.2697.8896.121.25
2182544-18254494.41395.21
3182490-18249094.38595.18
4184833-18483395.59796.40
5186124-18612496.26597.08
6182038-18203894.15194.94
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1195239-195239100.97999.121.30101.94100.081.29
2189669-18966998.09899.05
3190368-19036898.46099.41
4191663-19166399.129100.10
5193951-193951100.313101.29
6189029-18902997.76798.71
1440min1195558-195558101.14499.931.02102.27101.051.02
2192821-19282199.728100.84
3191775-19177599.187100.31
4193135-19313599.891101.02
5195354-195354101.038102.18
6190570-19057098.56499.67
极限1195759-195759101.24899.811.24102.54101.101.24
2190953-19095398.762100.04
3192862-19286299.750101.03
4193426-193426100.041101.34
5195264-195264100.992102.30
6189629-18962998.07799.35
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%
115.041739711741371739391746181742351741800.16
215.161748251745531746890.12
单位质量响应值RSD%判断
11581.1211523.020.36数据可信
供试品溶液-2025032321批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min129138-2913815.05514.872.3215.0614.882.31
228739-2873914.84914.85
327987-2798714.46114.46
428981-2898114.97414.97
529770-2977015.38215.38
628112-2811214.52514.53
60min149574-4957425.61425.741.6625.6425.771.65
250997-5099726.35026.37
349135-4913525.38825.41
450098-5009825.88525.91
550379-5037926.03026.06
648775-4877525.20225.23
120min180531-8053141.61041.031.6041.6841.101.60
280554-8055441.62141.69
378432-7843240.52540.59
479388-7938841.01941.09
580165-8016541.42041.49
677423-7742340.00440.07
240min1122524-12252463.30762.061.8463.4462.201.84
2122350-12235063.21763.36
3118762-11876261.36361.50
4119322-11932261.65261.79
5120803-12080362.41862.56
6116873-11687360.38760.52
360min1147235-14723576.07574.691.6576.3274.931.65
2147504-14750476.21476.46
3142853-14285373.81174.05
4143862-14386274.33274.57
5144325-14432574.57174.81
6141561-14156173.14373.38
480min1165166-16516685.34082.932.0985.7183.292.09
2163825-16382584.64785.02
3158724-15872482.01182.37
4157734-15773481.50081.86
5160554-16055482.95783.32
6156958-15695881.09981.45
600min1173658-17365889.72787.951.9290.2488.451.92
2174318-17431890.06890.58
3168261-16826186.93987.43
4167667-16766786.63287.13
5170874-17087488.28988.79
6166500-16650086.02986.52
720min1180525-18052593.27591.321.8793.9491.961.87
2180531-18053193.27993.94
3174712-17471290.27290.91
4173864-17386489.83490.48
5177598-17759891.76392.41
6173180-17318089.48090.11
960min1187404-18740496.83095.301.7597.6596.101.76
2188351-18835197.31998.14
3182523-18252394.30895.10
4182330-18233094.20895.00
5185840-18584096.02296.83
6180227-18022793.12193.90
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1195852-195852101.19599.171.88102.17100.131.88
2195906-195906101.223102.20
3190447-19044798.40299.35
4187864-18786497.06798.02
5193213-19321399.831100.80
6188296-18829697.29198.23
1440min1196234-196234101.392100.121.46102.54101.241.46
2196329-196329101.441102.59
3192613-19261399.521100.63
4193669-193669100.067101.18
5194894-194894100.700101.83
6188839-18883997.57198.67
极限1195749-195749101.14299.531.66102.46100.831.67
2195937-195937101.239102.56
3191417-19141798.903100.18
4189935-18993598.13899.42
5194444-194444100.467101.77
6188337-18833797.31298.57
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