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%
115.191739251739281737601742151740611739780.10
215.151740181743451741820.14
单位质量响应值RSD%判断
11453.4611497.160.27数据可信
加速3月-供试品溶液-2025081121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%
30min125120-2512013.06612.914.6713.0712.914.68
225794-2579413.41713.42
323208-2320812.07212.07
424238-2423812.60712.61
524199-2419912.58712.59
626355-2635513.70813.71
60min145410-4541023.62024.063.4823.6424.083.48
247709-4770924.81624.84
343988-4398822.88022.90
446029-4602923.94223.96
545920-4592023.88523.91
648434-4843425.19325.22
120min177048-7704840.07640.172.1740.1440.232.17
279130-7913041.15941.22
375078-7507839.05139.11
477021-7702140.06240.12
575897-7589739.47739.54
679204-7920441.19841.26
240min1117467-11746761.10060.131.4061.2360.261.41
2116131-11613160.40560.54
3113887-11388759.23859.36
4114666-11466659.64359.77
5114073-11407359.33459.46
6117375-11737561.05261.19
360min1141798-14179873.75572.840.9273.9973.070.92
2140258-14025872.95473.19
3138762-13876272.17672.40
4139343-13934372.47972.71
5138800-13880072.19672.42
6141237-14123773.46473.70
480min1157441-15744181.89281.140.6582.2481.480.66
2155760-15576081.01881.37
3155151-15515180.70181.04
4155598-15559880.93381.28
5154969-15496980.60680.95
6157023-15702381.67582.03
600min1173194-17319490.08689.240.6490.5889.730.64
2170746-17074688.81389.30
3171029-17102988.96089.44
4171458-17145889.18389.67
5170423-17042388.64589.12
6172570-17257089.76190.26
720min1179069-17906993.14292.430.4893.7893.070.48
2177161-17716192.14992.79
3176901-17690192.01492.64
4177292-17729292.21892.85
5177397-17739792.27292.90
6178423-17842392.80693.45
960min1185654-18565496.56795.740.5197.3696.520.51
2183061-18306195.21896.01
3183276-18327695.33096.11
4183804-18380495.60596.39
5184078-18407895.74796.53
6184478-18447895.95596.75
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1187464-18746497.50897.000.5398.4697.940.52
2185212-18521296.33797.29
3185358-18535896.41397.35
4186637-18663797.07898.02
5186914-18691497.22298.16
6187296-18729697.42198.38
1440min1190616-19061699.14898.880.64100.2799.990.64
2188170-18817097.87698.99
3189280-18928098.45399.55
4190199-19019998.931100.04
5191579-19157999.649100.75
6190799-19079999.243100.36
极限1190171-19017198.91698.700.46100.2099.980.46
2188515-18851598.05599.33
3188882-18888298.24699.51
4189952-18995298.803100.07
5190585-19058599.132100.40
6190462-19046299.068100.35
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%
115.191749721752181748671750871749981750280.08
215.151739711740081739900.02
单位质量响应值RSD%判断
11522.5811484.490.24数据可信
中间条件3月-供试品溶液-2025081121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%
30min123998-2399812.45212.652.6212.4512.652.63
225123-2512313.03613.04
323868-2386812.38412.38
425273-2527313.11313.11
524091-2409112.50012.50
623934-2393412.41912.42
60min144187-4418722.92722.852.1522.9522.872.15
245191-4519123.44823.47
342914-4291422.26722.29
445056-4505623.37823.40
543250-4325022.44122.46
643607-4360722.62622.65
120min174340-7434038.57337.792.2638.6337.852.26
274605-7460538.71038.77
370837-7083736.75536.81
473533-7353338.15438.21
570932-7093236.80436.86
672772-7277237.75937.82
240min1112213-11221358.22457.961.5858.3558.081.58
2114369-11436959.34259.47
3110702-11070257.44057.56
4112251-11225158.24358.37
5109115-10911556.61656.74
6111576-11157657.89358.01
360min1141523-14152373.43273.271.1973.6573.491.19
2143960-14396074.69674.92
3140419-14041972.85973.07
4141918-14191873.63773.86
5139104-13910472.17772.39
6140337-14033772.81673.03
480min1162648-16264884.39382.081.7084.7482.421.70
2159926-15992682.98083.33
3157202-15720281.56781.90
4157854-15785481.90582.25
5156143-15614381.01881.35
6155397-15539780.63180.97
600min1167685-16768587.00687.111.2687.4987.591.26
2171732-17173289.10689.59
3167541-16754186.93287.40
4167992-16799287.16687.65
5167044-16704486.67487.14
6165311-16531185.77586.25
720min1173175-17317589.85590.170.9590.4890.800.95
2176244-17624491.44792.08
3173728-17372890.14290.76
4174750-17475090.67291.30
5173555-17355590.05290.67
6171297-17129788.88189.50
960min1180472-18047293.64193.621.0394.4294.391.02
2182832-18283294.86695.65
3180000-18000093.39694.16
4181140-18114093.98894.76
5180928-18092893.87894.64
6177231-17723191.96092.72
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1186595-18659596.81896.771.1197.7597.701.11
2189514-18951498.33399.28
3185812-18581296.41297.33
4187117-18711797.08998.02
5186813-18681396.93197.85
6183166-18316695.03995.96
1440min1186680-18668096.86297.001.3197.9698.091.31
2189512-18951298.33299.44
3186044-18604496.53297.62
4189269-18926998.20699.30
5187291-18729197.17998.26
6182839-18283994.86995.95
极限1186587-18658796.81496.701.3098.0797.951.30
2188958-18895898.04499.32
3185607-18560796.30697.55
4186597-18659796.81998.08
5188310-18831097.70898.95
6182104-18210494.48895.72
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