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%
115.111760641761571762771759051756571760120.14
215.111741631740561741100.05
单位质量响应值RSD%判断
11648.7111522.830.77数据可信
供试品溶液-1231323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%
15min118956-189569.7669.135.029.779.135.03
216536-165368.5198.52
317385-173858.9578.96
418127-181279.3399.34
517047-170478.7838.78
618250-182509.4029.40
30min133694-3369417.35916.813.4717.3816.833.48
230770-3077015.85315.87
332839-3283916.91916.93
432904-3290416.95216.97
531890-3189016.43016.44
633702-3370217.36317.38
45min146430-4643023.92122.863.3223.9722.913.33
243603-4360322.46422.50
343523-4352322.42322.47
444670-4467023.01423.06
542451-4245121.87121.91
645587-4558723.48623.53
60min156638-5663829.18027.893.7029.2627.973.70
251208-5120826.38226.46
353903-5390327.77127.85
454900-5490028.28428.37
552566-5256627.08227.16
655588-5558828.63928.72
75min165208-6520833.59532.913.2333.7333.043.23
259898-5989830.85930.98
364391-6439133.17433.30
464028-6402832.98733.12
564092-6409233.02033.14
665699-6569933.84833.98
90min173473-7347337.85336.483.1138.0436.673.10
267435-6743534.74234.92
370214-7021436.17436.36
471981-7198137.08537.27
569497-6949735.80535.98
672284-7228437.24137.43
105min180969-8096941.71540.253.0641.9740.493.07
274456-7445638.36038.59
377398-7739839.87540.12
479665-7966541.04341.29
576690-7669039.51139.75
679552-7955240.98541.24
120min187964-8796445.31943.802.4945.6444.112.49
282173-8217342.33542.63
384363-8436343.46443.77
486345-8634544.48544.80
583403-8340342.96943.27
685865-8586544.23844.56
极限193873-9387348.36346.772.4848.7647.162.49
287906-8790645.28945.65
389568-8956846.14546.53
492754-9275447.78748.18
589408-8940846.06346.44
691220-9122046.99647.39
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%
115.111745381744921741251747561748171745460.16
215.111748291744311746300.17
单位质量响应值RSD%判断
11551.6911557.250.04数据可信
供试品溶液-1231323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%
15min118158-181589.3809.292.009.389.292.00
218029-180299.3139.31
317636-176369.1109.11
417463-174639.0219.02
518385-183859.4979.50
618217-182179.4119.41
30min132473-3247316.77516.811.3316.7916.821.34
232509-3250916.79316.81
332329-3232916.70016.72
432018-3201816.54016.55
533318-3331817.21117.23
632587-3258716.83416.85
45min144389-4438922.93022.861.3922.9722.901.38
244014-4401422.73722.78
343889-4388922.67222.72
443510-4351022.47622.52
545296-4529623.39923.44
644394-4439422.93322.98
60min155514-5551428.67728.141.7628.7628.221.76
253561-5356127.66927.75
354300-5430028.05028.13
453260-5326027.51327.59
555520-5552028.68028.76
654684-5468428.24928.33
75min163241-6324132.66932.480.8932.8032.610.89
262257-6225732.16132.29
362740-6274032.41032.54
462203-6220332.13332.26
563535-6353532.82132.95
663245-6324532.67132.80
90min171337-7133736.85136.660.8837.0436.850.88
270029-7002936.17636.36
371093-7109336.72536.91
470401-7040136.36836.55
571567-7156736.97037.16
671429-7142936.89937.08
105min178577-7857740.59140.470.9540.8440.710.96
277142-7714239.85040.09
378302-7830240.44940.69
477923-7792340.25340.49
578832-7883240.72340.97
679257-7925740.94341.19
120min185643-8564344.24144.171.2444.5544.481.24
284362-8436243.58043.89
385636-8563644.23844.55
484397-8439743.59843.90
585790-8579044.31744.63
687222-8722245.05745.37
极限190861-9086146.93746.920.6547.3247.300.64
290066-9006646.52646.91
391517-9151747.27647.66
490204-9020446.59846.98
590967-9096746.99247.38
691303-9130347.16547.55
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