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%
114.801727181726401732831731091730731729650.16
214.811714801719041716920.18
单位质量响应值RSD%判断
11686.8211592.980.58数据可信
供试品溶液-25052601-1-bc1-js1Mjs1M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%
30min124382-2438212.50312.693.7812.5012.693.77
225219-2521912.93212.93
324794-2479412.71412.71
425271-2527112.95912.96
523102-2310211.84711.85
625756-2575613.20813.21
60min144529-4452922.83423.163.4722.8623.183.46
246532-4653223.86123.88
343816-4381622.46922.49
445844-4584423.50923.53
543154-4315422.12922.15
647072-4707224.13824.16
120min175440-7544038.68538.773.4038.7438.833.40
278150-7815040.07540.14
372615-7261537.23737.30
476341-7634139.14739.21
572625-7262537.24237.30
678441-7844140.22440.29
240min1118099-11809960.56160.272.5460.6860.402.54
2120326-12032661.70361.83
3113634-11363458.27158.39
4117728-11772860.37060.50
5114467-11446758.69858.82
6120941-12094162.01862.15
360min1147182-14718275.47475.571.3875.7075.791.38
2148383-14838376.09076.32
3144503-14450374.10174.32
4147760-14776075.77176.00
5145967-14596774.85175.07
6150378-15037877.11377.35
480min1164339-16433984.27284.410.9084.6284.760.91
2164563-16456384.38784.75
3162416-16241683.28683.63
4164660-16466084.43784.79
5164571-16457184.39184.73
6167075-16707585.67586.04
600min1174016-17401689.23589.370.7089.7389.860.70
2173774-17377489.11189.61
3172546-17254688.48188.96
4174409-17440989.43689.93
5174678-17467889.57490.06
6176238-17623890.37490.88
720min1179215-17921591.90192.260.7692.5492.900.76
2178512-17851291.54092.19
3178571-17857191.57192.20
4180390-18039092.50393.15
5181008-18100892.82093.45
6181769-18176993.21093.87
960min1184782-18478294.75695.140.6695.5595.940.66
2185685-18568595.21996.02
3183782-18378294.24395.02
4185298-18529895.02095.82
5186585-18658595.68096.47
6187110-18711095.94996.76
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1187313-18731396.05395.950.7097.0096.900.70
2184839-18483994.78595.74
3186812-18681295.79696.73
4186961-18696195.87396.83
5188195-18819596.50697.45
6188524-18852496.67497.64
1440min1188600-18860096.71396.480.7297.8297.590.71
2185976-18597695.36896.48
3187498-18749896.14897.25
4188105-18810596.46097.57
5188771-18877196.80197.91
6189937-18993797.39998.53
极限1190929-19092997.90896.630.9299.1897.910.91
2186079-18607995.42196.70
3187228-18722896.01097.27
4187968-18796896.38997.67
5189100-18910096.97098.24
6189344-18934497.09598.39
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%
114.801719341721581724811720241716421720480.18
214.811714781715191714980.02
单位质量响应值RSD%判断
11624.8611579.880.28数据可信
供试品溶液-25052601-1-bc2-js1Mjs1M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%
30min125580-2558013.16012.892.5513.1612.902.57
224657-2465712.68512.68
325223-2522312.97612.98
425344-2534413.03813.04
525611-2561113.17613.18
623967-2396712.33012.33
60min146016-4601623.67323.412.6523.6923.432.64
244197-4419722.73722.76
344834-4483423.06523.09
446124-4612423.72823.75
547349-4734924.35924.38
644493-4449322.88922.91
120min176954-7695439.58939.241.5239.6539.301.53
274052-7405238.09638.15
376466-7646639.33839.40
477382-7738239.80939.87
576454-7645439.33239.39
676309-7630939.25739.32
240min1119593-11959361.52460.681.0661.6560.801.07
2115777-11577759.56159.68
3118103-11810360.75860.88
4118514-11851460.96961.10
5117780-11778060.59260.72
6117942-11794260.67560.80
360min1149664-14966476.99475.900.8277.2276.120.82
2146426-14642675.32975.55
3147673-14767375.97076.20
4147854-14785476.06376.29
5146456-14645675.34475.57
6147109-14710975.68075.91
480min1167187-16718786.00984.640.8886.3785.000.88
2164028-16402884.38484.73
3164603-16460384.68085.03
4164543-16454384.64985.00
5162921-16292183.81484.17
6163930-16393084.33484.68
600min1177581-17758191.35689.690.9691.8690.180.95
2173488-17348889.25189.74
3174526-17452689.78590.28
4173722-17372289.37189.87
5173103-17310389.05389.55
6173595-17359589.30689.80
720min1184198-18419894.76092.481.3095.4193.131.30
2179125-17912592.15192.79
3180079-18007992.64193.29
4178521-17852191.84092.49
5177478-17747891.30391.95
6179214-17921492.19692.84
960min1189058-18905897.26195.451.0098.0796.251.00
2184981-18498195.16395.95
3185972-18597295.67396.47
4184823-18482395.08295.88
5184489-18448994.91095.71
6183947-18394794.63195.43
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1191542-19154298.53896.311.3299.5197.261.32
2186458-18645895.92396.87
3188036-18803696.73597.69
4187056-18705696.23197.19
5184282-18428294.80495.76
6185867-18586795.61996.57
1440min1192834-19283499.20396.811.42100.3497.931.41
2187994-18799496.71397.82
3188530-18853096.98998.11
4187862-18786296.64597.76
5184639-18463994.98796.10
6187266-18726696.33997.45
极限1192903-19290399.23996.721.48100.5498.001.47
2187824-18782496.62697.90
3187822-18782296.62597.91
4188155-18815596.79698.08
5184374-18437494.85196.12
6187016-18701696.21097.48
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