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%
114.941726501727971726881729751725381727300.10
214.941729011728511728760.03
单位质量响应值RSD%判断
11561.5811571.350.06数据可信
供试品溶液-1276525批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min131900-3190016.46216.562.3216.4616.562.32
231792-3179216.40616.41
332903-3290316.97916.98
432983-3298317.02117.02
532000-3200016.51316.51
631006-3100616.00016.00
60min152836-5283627.26627.602.0227.2927.622.02
252868-5286827.28227.31
354434-5443428.09028.12
454702-5470228.22928.26
554057-5405727.89627.92
651979-5197926.82326.85
120min184156-8415643.42843.451.8343.5043.531.83
282571-8257142.61042.68
385467-8546744.10544.18
485903-8590344.33044.41
584955-8495543.84043.91
682191-8219142.41442.49
240min1130119-13011967.14767.291.2967.2967.441.29
2127961-12796166.03366.18
3131034-13103467.61967.77
4133032-13303268.65068.80
5130682-13068267.43867.58
6129604-12960466.88167.02
360min1156875-15687580.95481.791.6181.2182.051.61
2156149-15614980.58080.83
3157946-15794681.50781.77
4163358-16335884.30084.56
5158602-15860281.84682.11
6158074-15807481.57381.83
480min1174447-17444790.02290.631.0590.4191.031.05
2174413-17441390.00590.39
3174731-17473190.16990.57
4179261-17926192.50692.91
5175467-17546790.54990.94
6175480-17548090.55590.94
600min1184551-18455195.23695.991.2195.7896.541.21
2184329-18432995.12295.66
3184398-18439895.15795.70
4190058-19005898.07898.64
5187016-18701696.50897.06
6185740-18574095.85096.39
720min1190275-19027598.19098.301.4198.8999.001.40
2188999-18899997.53298.23
3187910-18791096.97097.68
4195506-195506100.890101.61
5189265-18926597.66998.38
6190915-19091598.52099.22
960min1192764-19276499.47599.661.46100.34100.531.45
2191944-19194499.05199.91
3190651-19065198.38499.25
4198628-198628102.501103.39
5192091-19209199.127100.00
6192666-19266699.424100.29
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1193580-19358099.89699.671.49100.93100.711.49
2191301-19130198.72099.74
3190029-19002998.06399.09
4198389-198389102.377103.44
5192520-19252099.349100.38
6193061-19306199.628100.66
1440min1192108-19210899.13699.401.45100.33100.601.45
2191449-19144998.79699.98
3190150-19015098.12699.32
4198075-198075102.215103.45
5191514-19151498.830100.03
6192425-19242599.300100.50
极限1194986-194986100.62199.451.65101.98100.821.64
2191372-19137298.756100.11
3188846-18884697.45398.81
4197668-197668102.005103.41
5190743-19074398.43299.80
6192689-19268999.436100.80
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%
114.941728321729671726531725201722051726350.18
214.941727321728771728040.06
单位质量响应值RSD%判断
11555.2211566.530.07数据可信
供试品溶液-1276525批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min130744-3074415.87316.262.1315.8716.262.13
232210-3221016.63016.63
332083-3208316.56416.56
431262-3126216.14016.14
530727-3072715.86415.86
631899-3189916.46916.47
60min151074-5107426.36927.032.5526.4027.062.55
254253-5425328.01028.04
353075-5307527.40227.43
451786-5178626.73726.76
550876-5087626.26726.29
653116-5311627.42327.45
120min180672-8067241.65042.591.9441.7242.661.95
285055-8505543.91343.99
383009-8300942.85742.93
482404-8240442.54542.62
580922-8092241.77941.85
682911-8291142.80642.88
240min1126650-12665065.38966.161.2865.5366.301.28
2130508-13050867.38067.53
3129323-12932366.76966.91
4127236-12723665.69165.83
5126442-12644265.28165.42
6128729-12872966.46266.61
360min1157078-15707881.09880.970.8581.3581.230.85
2157561-15756181.34881.61
3157595-15759581.36581.62
4154710-15471079.87680.13
5155791-15579180.43480.68
6158273-15827381.71581.97
480min1175486-17548690.60290.131.1190.9990.521.11
2174587-17458790.13890.53
3175688-17568890.70791.10
4171631-17163188.61289.00
5173112-17311289.37789.76
6176966-17696691.36691.76
600min1186152-18615296.10995.231.3896.6495.771.38
2183312-18331294.64395.19
3186019-18601996.04096.58
4181255-18125593.58194.11
5182280-18228094.11094.64
6187728-18772896.92397.47
720min1190647-19064798.43097.991.6299.1298.691.62
2187810-18781096.96597.67
3193400-19340099.851100.55
4186299-18629996.18596.87
5187432-18743296.77097.46
6193215-19321599.756100.46
960min1193789-193789100.05299.431.63100.91100.281.62
2190145-19014598.17199.04
3195000-195000100.677101.55
4189593-18959397.88698.73
5189915-18991598.05298.90
6197006-197006101.713102.58
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1194022-194022100.17299.361.65101.20100.391.65
2190163-19016398.18099.21
3194833-194833100.591101.63
4189139-18913997.65198.66
5189779-18977997.98298.99
6196776-196776101.594102.64
1440min1192712-19271299.49699.031.73100.69100.221.72
2189218-18921897.69298.88
3194305-194305100.318101.52
4188425-18842597.28398.46
5189444-18944497.80998.99
6196712-196712101.561102.77
极限1193373-19337399.83798.781.85101.20100.141.84
2187752-18775296.93598.29
3193627-19362799.968101.34
4187905-18790597.01498.35
5189139-18913997.65198.99
6196176-196176101.284102.66
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