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ZZ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%
111.037131370951711217143470859711360.34
211.037102670996710110.03
单位质量响应值RSD%判断
6449.326437.990.13数据可信
供试品溶液-J057M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%
5min151328-5132871.46970.442.6871.4770.442.69
248889-4888968.07368.07
350110-5011069.77369.77
449718-4971869.22769.23
552769-5276973.47573.48
650705-5070570.60170.60
10min162783-6278387.41986.811.3987.5486.931.38
262161-6216186.55386.67
360903-6090384.80184.92
461963-6196386.27786.39
563134-6313487.90788.03
663141-6314187.91788.03
15min164495-6449589.80289.590.7390.0789.860.73
264309-6430989.54389.80
363645-6364588.61988.88
464212-6421289.40889.67
564323-6432389.56389.83
665085-6508590.62490.89
20min164560-6456089.89389.860.8190.3190.270.81
264202-6420289.39589.80
364233-6423389.43889.84
464331-6433189.57489.98
564337-6433789.58290.00
665565-6556591.29291.71
30min165021-6502190.53590.631.2691.1091.191.26
265058-6505890.58691.14
364519-6451989.83690.39
464656-6465690.02790.58
564596-6459689.94390.51
666696-6669692.86793.43
45min165431-6543191.10690.810.8991.8291.520.89
265322-6532290.95491.66
364600-6460089.94990.65
465012-6501290.52291.23
564757-6475790.16790.88
666202-6620292.17992.90
60min165646-6564691.40591.260.8692.2792.120.86
265403-6540391.06791.93
365148-6514890.71291.57
465164-6516490.73491.59
565263-6526390.87291.74
666615-6661592.75493.63
90min165859-6585991.70291.440.6992.7292.450.68
265595-6559591.33492.34
365520-6552091.23092.23
465434-6543491.11092.12
565160-6516090.72891.75
666457-6645792.53493.56
极限167532-6753294.03193.741.0095.2094.900.99
267887-6788794.52595.69
367663-6766394.21495.37
466813-6681393.03094.19
566197-6619792.17293.34
667827-6782794.44295.63
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ZZ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%
111.033504134982351673503235089350620.20
211.033550235490354960.03
单位质量响应值RSD%判断
3178.793218.130.87数据可信
供试品溶液-J187N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%
5min126428-2642874.13772.273.8474.1472.283.84
227042-2704275.85975.86
326360-2636073.94673.95
424472-2447268.65068.65
525155-2515570.56670.57
625123-2512370.47670.48
10min131516-3151688.41088.102.3188.5388.222.31
231811-3181189.23789.36
332279-3227990.55090.67
431773-3177389.13189.25
530595-3059585.82685.94
630466-3046685.46485.58
15min132422-3242290.95191.102.2191.2291.362.21
232652-3265291.59791.87
333311-3331193.44593.72
433159-3315993.01993.28
531745-3174589.05289.31
631560-3156088.53388.79
20min132435-3243590.98891.272.3591.4191.692.35
232733-3273391.82492.25
333475-3347593.90594.34
433230-3323093.21893.64
531626-3162688.71889.13
631714-3171488.96589.37
30min132853-3285392.16092.092.2592.7392.662.25
233033-3303392.66593.25
333689-3368994.50695.09
433480-3348093.91994.49
531955-3195589.64190.20
631963-3196389.66490.22
45min132821-3282192.07192.622.2392.8093.342.23
233293-3329393.39594.13
333899-3389995.09595.84
433680-3368094.48095.21
532335-3233590.70791.41
632065-3206589.95090.66
60min133440-3344093.80793.582.0794.6994.462.06
233563-3356394.15295.04
334104-3410495.67096.57
433672-3367294.45895.35
533307-3330793.43494.29
632070-3207089.96490.82
90min133541-3354194.09193.581.7095.1394.621.71
233459-3345993.86094.91
333971-3397195.29796.36
433850-3385094.95796.00
532634-3263491.54692.56
632708-3270891.75492.76
极限134218-3421895.99095.060.9997.1896.250.99
234004-3400495.38996.59
333885-3388595.05696.28
433864-3386494.99796.20
534090-3409095.63196.80
633257-3325793.29494.45
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