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%
1 15.191744241744621737111740421737911740860.21
2 15.151752211747001749600.22
单位质量响应值RSD%判断
11460.5711548.510.55数据可信
加速3月-供试品溶液-2025081221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%
30min123839-2383912.36812.853.4112.3712.853.41
226114-2611413.54913.55
324249-2424912.58112.58
425381-2538113.16813.17
524759-2475912.84612.85
624278-2427812.59612.60
60min143430-4343022.53323.293.9222.5523.313.92
247218-4721824.49824.52
343476-4347622.55722.58
446929-4692924.34824.37
543595-4359522.61822.64
644707-4470723.19523.22
120min172608-7260837.67138.464.0137.7338.524.01
276598-7659839.74139.80
370093-7009336.36636.42
478297-7829740.62340.69
572779-7277937.76037.82
674430-7443038.61638.68
240min1111618-11161857.91158.192.4958.0358.312.49
2115574-11557459.96360.09
3107979-10797956.02356.14
4114998-11499859.66459.79
5111358-11135857.77657.90
6111401-11140157.79857.92
360min1136951-13695171.05471.010.9571.2771.230.95
2137219-13721971.19371.42
3134502-13450269.78470.00
4138354-13835471.78272.01
5137445-13744571.31071.53
6136676-13667670.91171.13
480min1153085-15308579.42579.550.8579.7679.890.85
2153884-15388479.83980.19
3151202-15120278.44878.78
4154830-15483080.33080.68
5154234-15423480.02180.36
6152729-15272979.24079.58
600min1169355-16935587.86687.690.4488.3388.160.44
2169534-16953487.95988.44
3167917-16791787.12087.58
4168516-16851687.43187.91
5169940-16994088.17088.64
6168774-16877487.56588.04
720min1176061-17606191.34691.010.7791.9691.630.76
2176493-17649391.57092.20
3173984-17398490.26890.87
4175050-17505090.82191.45
5177076-17707691.87292.49
6173877-17387790.21290.83
960min1181757-18175794.30194.100.8495.0794.870.83
2181239-18123994.03294.81
3180882-18088293.84794.60
4179929-17992993.35294.13
5184153-18415395.54496.31
6180264-18026493.52694.29
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1183919-18391995.42295.590.7496.3596.520.74
2185291-18529196.13497.07
3184143-18414395.53996.45
4182843-18284394.86495.80
5186328-18632896.67297.60
6182934-18293494.91195.83
1440min1188644-18864497.87497.450.7598.9698.540.74
2187668-18766897.36898.47
3187845-18784597.45998.53
4185880-18588096.44097.53
5189972-18997298.56399.65
6186958-18695896.99998.08
极限1188359-18835997.72697.250.7698.9798.500.75
2187517-18751797.28998.55
3187151-18715197.09998.33
4185571-18557196.28097.53
5189565-18956598.35299.61
6186470-18647096.74697.99
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%
1 15.191739171733481745991736111742741739500.29
2 15.151742251744911743580.11
单位质量响应值RSD%判断
11451.6111508.780.36数据可信
中间条件3月-供试品溶液-2025081221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%
30min124898-2489812.94512.932.1212.9512.942.11
225193-2519313.09813.10
325340-2534013.17513.17
424644-2464412.81312.81
523937-2393712.44512.45
625245-2524513.12513.13
60min144759-4475923.27123.122.7923.2923.142.79
244647-4464723.21323.23
345383-4538323.59623.62
443762-4376222.75322.77
542395-4239522.04222.06
645852-4585223.84023.86
120min171474-7147437.16138.327.2537.2238.387.24
272326-7232637.60437.66
374001-7400138.47538.54
471988-7198837.42837.49
568482-6848235.60535.66
683977-8397743.66243.72
240min1109403-10940356.88157.663.4057.0057.783.40
2114378-11437859.46859.59
3113320-11332058.91859.04
4110492-11049257.44857.57
5104285-10428554.22054.34
6113481-11348159.00259.14
360min1139396-13939672.47572.822.6372.6973.042.64
2142236-14223673.95274.17
3141590-14159073.61673.84
4140219-14021972.90373.12
5133206-13320669.25769.46
6143697-14369774.71274.94
480min1155644-15564480.92381.452.2481.2681.792.24
2157973-15797382.13482.48
3157069-15706981.66482.01
4159427-15942782.89083.23
5150172-15017278.07878.40
6159611-15961182.98683.34
600min1165353-16535385.97186.702.1586.4487.182.15
2170029-17002988.40288.88
3167542-16754287.10987.59
4168358-16835887.53388.01
5160203-16020383.29383.75
6169043-16904387.89088.39
720min1173113-17311390.00690.291.9790.6290.911.97
2177418-17741892.24492.87
3173751-17375190.33790.97
4175698-17569891.35091.97
5167441-16744187.05787.65
6174554-17455490.75591.40
960min1180638-18063893.91893.601.8594.6894.381.85
2183807-18380795.56696.35
3178406-17840692.75893.54
4182224-18222494.74395.52
5174334-17433490.64191.38
6180780-18078093.99294.79
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1184778-18477896.07196.582.0196.9997.502.01
2190743-19074399.172100.11
3185213-18521396.29797.23
4187995-18799597.74398.68
5179592-17959293.37494.26
6186198-18619896.80997.76
1440min1186179-18617996.79996.912.1497.8898.002.14
2190909-19090999.258100.37
3185659-18565996.52997.62
4188906-18890698.21799.31
5179249-17924993.19694.24
6187495-18749597.48398.59
极限1186328-18632896.87796.982.1598.1298.222.15
2190566-19056699.080100.35
3184885-18488596.12697.38
4191012-19101299.312100.57
5180115-18011593.64694.84
6186213-18621396.81798.09
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