多替诺雷片项目信息
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D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.316668066262662266652666579664550.31
210.256593765905659210.04
单位质量响应值RSD%判断
6445.686431.320.16数据可信
中间条件6月-供试品溶液-2025072121批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min111652-1165216.23718.4813.3916.2418.4813.39
213430-1343018.71518.71
312623-1262317.59017.59
414209-1420919.80019.80
511468-1146815.98115.98
616198-1619822.57222.57
10min121227-2122729.58032.359.3529.6132.389.36
223706-2370633.03533.07
322810-2281031.78631.82
423780-2378033.13833.17
520874-2087429.08829.11
626873-2687337.44837.49
15min127898-2789838.87641.455.9338.9541.545.95
230469-3046942.45942.55
329391-2939140.95741.04
430243-3024342.14442.23
527920-2792038.90738.98
632556-3255645.36745.47
20min133531-3353146.72647.834.0246.8747.994.04
234752-3475248.42748.58
333737-3373747.01347.16
434653-3465348.28948.45
532636-3263645.47945.62
636649-3664951.07151.25
30min140051-4005155.81156.242.7856.0356.472.80
240939-4093957.04957.29
340061-4006155.82556.05
440214-4021456.03956.28
538747-3874753.99454.21
642133-4213358.71358.97
45min146285-4628564.49964.072.9364.8164.392.94
246320-4632064.54764.88
345537-4553763.45663.78
445790-4579063.80964.14
543881-4388161.14961.45
648032-4803266.93367.29
60min149488-4948868.96268.992.4469.3869.432.45
250089-5008969.79970.24
349441-4944168.89769.32
449315-4931568.72169.16
547519-4751966.21866.63
651217-5121771.37171.84
90min154255-5425575.60574.742.2876.1475.292.29
253509-5350974.56575.12
353811-5381174.98675.53
453234-5323474.18274.74
551650-5165071.97572.49
655347-5534777.12777.72
120min156219-5621978.34277.842.1579.0078.512.16
255842-5584277.81678.50
356150-5615078.24678.91
455682-5568277.59378.27
553771-5377174.93075.57
657469-5746980.08480.80
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限157792-5779280.53479.781.0981.3280.581.11
256981-5698179.40480.21
356839-5683979.20680.00
456782-5678279.12679.93
556835-5683579.20079.96
658256-5825681.18082.03
多替诺雷片项目信息
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D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.316590365598662766594565848659140.37
210.256607066223661460.17
单位质量响应值RSD%判断
6393.216453.270.67数据可信
中间条件6月-供试品溶液-2025072221批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110536-1053614.71716.4210.7614.7216.4210.74
211835-1183516.53216.53
313511-1351118.87318.87
411868-1186816.57816.58
512650-1265017.67017.67
610142-1014214.16714.17
10min120104-2010428.08230.045.6328.1130.075.63
221642-2164230.23130.26
323240-2324032.46332.49
421814-2181430.47130.50
522109-2210930.88330.91
620138-2013828.13028.15
15min127274-2727438.09839.074.0538.1739.154.06
228456-2845639.74939.83
329538-2953841.26041.35
428119-2811939.27839.36
528231-2823139.43439.52
626200-2620036.59736.67
20min132312-3231245.13545.823.1845.2745.963.19
233375-3337546.62046.76
334300-3430047.91248.07
433109-3310946.24846.39
532479-3247945.36845.51
631246-3124643.64643.78
30min138692-3869254.04754.332.2654.2654.552.26
239223-3922354.78955.01
340213-4021356.17156.41
439330-3933054.93855.16
538052-3805253.15353.38
637869-3786952.89753.10
45min144100-4410061.60161.751.5861.9062.061.59
244363-4436361.96862.28
345253-4525363.21263.54
444568-4456862.25562.57
543264-4326460.43360.74
643683-4368361.01961.31
60min148597-4859767.88367.191.8568.2967.601.85
248508-4850867.75868.17
349304-4930468.87069.30
448045-4804567.11267.53
547092-4709265.78066.19
647072-4707265.75266.15
90min152771-5277173.71372.851.4874.2373.371.49
252642-5264273.53374.06
352725-5272573.64974.20
452425-5242573.23073.76
551067-5106771.33371.85
651277-5127771.62672.13
120min155451-5545177.45776.681.7078.1077.321.71
255576-5557677.63178.28
355866-5586678.03678.71
454945-5494576.75077.40
553901-5390175.29275.93
653612-5361274.88875.51
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限156500-5650078.92278.181.1479.6978.951.15
256186-5618678.48379.26
356791-5679179.32880.13
455796-5579677.93978.72
555245-5524577.16977.93
655295-5529577.23977.99
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