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%
115.111757991753331758351752061749471754240.22
215.111761141763791762460.11
单位质量响应值RSD%判断
11609.7911664.200.34数据可信
供试品溶液-1270307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%
15min118081-180819.2749.251.709.279.251.70
217466-174668.9598.96
318216-182169.3439.34
417913-179139.1889.19
518300-183009.3869.39
618196-181969.3339.33
30min132235-3223516.53416.621.4216.5516.631.42
231767-3176716.29416.31
332451-3245116.64516.66
432392-3239216.61416.63
532361-3236116.59916.61
633182-3318217.02017.04
45min143996-4399622.56622.621.8122.6122.661.80
243084-4308422.09922.14
344097-4409722.61822.66
444876-4487623.01823.06
543430-4343022.27622.32
645130-4513023.14823.19
60min153985-5398527.69027.952.3427.7728.032.34
252606-5260626.98327.06
355965-5596528.70528.79
453838-5383827.61527.70
555758-5575828.59928.68
654758-5475828.08628.17
75min162760-6276032.19131.881.5132.3232.011.51
260722-6072231.14531.27
362585-6258532.10132.23
462814-6281432.21832.35
561202-6120231.39231.52
662814-6281432.21832.35
90min170059-7005935.93535.941.1936.1136.121.20
268948-6894835.36535.54
370505-7050536.16336.35
470690-7069036.25836.44
569194-6919435.49135.67
671000-7100036.41736.60
105min176897-7689739.44239.401.2239.6839.641.22
275919-7591938.94039.18
377664-7766439.83540.08
477300-7730039.64939.89
575437-7543738.69338.93
677642-7764239.82440.07
120min184005-8400543.08842.761.1743.3943.061.16
282644-8264442.39042.69
384093-8409343.13343.44
483264-8326442.70843.02
581838-8183841.97642.28
684305-8430543.24243.55
极限188997-8899745.64845.371.2346.0345.751.23
287387-8738744.82245.19
389413-8941345.86246.24
489241-8924145.77346.15
586806-8680644.52444.90
688907-8890745.60245.98
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%
115.111756961760631759561758851759181759040.08
215.111759921768461764190.35
单位质量响应值RSD%判断
11641.5611675.650.21数据可信
供试品溶液-2025081121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%
15min116854-168548.6298.8610.638.638.8610.63
216963-169638.6848.68
316686-166868.5438.54
420630-2063010.56210.56
515064-150647.7127.71
617660-176609.0419.04
30min132677-3267716.73016.554.4216.7416.564.44
232485-3248516.63116.65
332718-3271816.75116.76
432331-3233116.55216.57
529693-2969315.20215.21
634049-3404917.43217.45
45min145464-4546423.27623.033.9923.3223.084.00
245258-4525823.17123.21
346142-4614223.62323.67
445167-4516723.12423.17
541478-4147821.23521.27
646445-4644523.77823.82
60min156422-5642228.88628.553.5728.9728.633.57
256133-5613328.73828.82
356765-5676529.06229.14
455935-5593528.63728.72
551859-5185926.55026.62
657457-5745729.41629.50
75min164990-6499033.27333.302.7033.4033.432.71
265653-6565333.61233.74
366239-6623933.91234.04
464728-6472833.13933.27
561818-6181831.64931.77
666807-6680734.20334.34
90min173787-7378737.77637.733.8137.9637.923.81
275061-7506138.42938.61
374920-7492038.35738.54
473844-7384437.80637.99
568301-6830134.96835.14
676309-7630939.06839.26
105min181099-8109941.52041.273.0541.7741.523.05
280657-8065741.29441.54
382630-8263042.30442.55
481036-8103641.48841.74
575878-7587838.84739.08
682413-8241342.19342.45
120min188272-8827245.19244.773.1145.5145.093.11
287286-8728644.68745.01
389414-8941445.77746.10
487755-8775544.92845.25
582255-8225542.11242.41
689714-8971445.93146.26
极限194396-9439648.32847.522.9748.7247.912.98
293205-9320547.71848.11
394732-9473248.50048.90
492755-9275547.48747.88
587429-8742944.76145.12
694413-9441348.33648.74
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%
115.111762611761241756311759471762561760440.15
215.111768031766341767180.07
单位质量响应值RSD%判断
11650.8311695.430.28数据可信
供试品溶液-2025081221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%
15min116629-166298.5038.561.628.508.561.62
216589-165898.4828.48
316738-167388.5598.56
416764-167648.5728.57
516448-164488.4108.41
617233-172338.8128.81
30min131659-3165916.18816.271.5416.2016.281.53
231454-3145416.08316.10
332210-3221016.47016.48
431148-3114815.92715.94
532028-3202816.37716.39
632439-3243916.58716.60
45min143932-4393222.46422.740.9922.5022.781.00
244136-4413622.56822.61
344980-4498023.00023.04
444221-4422122.61222.65
544725-4472522.86922.91
644897-4489722.95723.00
60min154442-5444227.83827.891.3127.9227.971.31
254044-5404427.63427.71
355286-5528628.26928.35
453475-5347527.34327.42
555290-5529028.27128.35
654709-5470927.97428.05
75min163525-6352532.48232.751.4132.6132.881.40
263645-6364532.54432.67
364933-6493333.20233.33
462863-6286332.14432.27
564076-6407632.76432.89
665236-6523633.35733.48
90min171663-7166336.64336.951.1736.8237.131.16
272541-7254137.09237.27
373289-7328937.47537.66
470948-7094836.27836.46
572811-7281137.23037.41
672292-7229236.96537.15
105min178670-7867040.22640.611.0040.4740.861.00
279183-7918340.48940.73
380372-8037241.09741.34
478497-7849740.13840.38
580266-8026641.04241.29
679545-7954540.67440.92
120min185420-8542043.67844.080.9343.9944.390.93
286886-8688644.42744.74
387139-8713944.55744.87
485184-8518443.55743.86
586586-8658644.27444.59
686053-8605344.00144.31
极限190827-9082746.44346.951.0146.8247.331.01
293076-9307647.59347.97
392429-9242947.26247.65
490845-9084546.45246.83
592302-9230247.19747.58
691443-9144346.75847.14
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