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%
19.946400463899633616363963408636620.46
210.006427864283642800.01
单位质量响应值RSD%判断
6404.636428.000.26数据可信
供试品溶液-2025072321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130540-3054042.70541.912.4742.7141.912.47
230973-3097343.31143.31
329798-2979841.66741.67
430171-3017142.18942.19
529011-2901140.56740.57
629336-2933641.02141.02
10min140879-4087957.16257.801.5857.2357.871.58
242210-4221059.02459.10
341496-4149658.02558.09
441905-4190558.59758.67
540507-4050756.64256.71
640998-4099857.32957.40
15min145486-4548663.60465.342.3263.7765.512.32
247361-4736166.22666.40
347070-4707065.81965.99
448359-4835967.62267.79
545740-4574063.96064.12
646345-4634564.80664.97
20min148549-4854967.88869.972.0968.1670.252.09
250627-5062770.79371.07
350478-5047870.58570.86
451514-5151472.03472.31
549479-4947969.18869.46
649592-4959269.34669.62
30min152470-5247073.37075.762.0473.7676.152.03
254157-5415775.72976.13
355023-5502376.94077.33
455665-5566577.83878.24
553999-5399975.50875.89
653760-5376075.17475.56
45min155825-5582578.06280.242.2278.5780.762.21
257627-5762780.58281.11
357970-5797081.06181.58
459464-5946483.15083.68
556645-5664579.20879.72
656778-5677879.39479.91
60min157277-5727780.09282.191.8980.7382.841.89
259090-5909082.62783.29
359077-5907782.60983.27
460551-6055184.67085.34
558629-5862981.98382.62
658050-5805081.17381.82
90min159984-5998483.87785.441.3684.6586.231.36
261781-6178186.39087.19
360306-6030684.32885.12
462066-6206686.78987.60
561033-6103385.34486.12
661456-6145685.93686.72
120min161551-6155186.06987.072.1486.9888.002.13
264739-6473990.52791.47
361039-6103985.35386.29
462725-6272587.71088.67
561905-6190586.56487.48
661637-6163786.18987.11
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162654-6265487.61188.510.9588.6789.590.95
264400-6440090.05391.14
363006-6300688.10389.18
463477-6347788.76289.86
563158-6315888.31689.38
663098-6309888.23289.30
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%
19.943192632127319703193032013319930.26
210.003285232871328620.05
单位质量响应值RSD%判断
3218.613286.201.47数据可信
供试品溶液-2025072421批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117633-1763348.64846.624.0148.6546.624.01
216102-1610244.42444.42
317758-1775848.99348.99
416365-1636545.14945.15
516940-1694046.73646.74
616592-1659245.77645.78
10min124019-2401966.26664.002.4366.3564.082.43
222800-2280062.90362.98
323661-2366165.27865.36
422520-2252062.13062.21
523248-2324864.13964.22
622930-2293063.26263.34
15min126862-2686274.11071.912.8074.3072.092.80
225396-2539670.06570.24
326898-2689874.20974.40
425213-2521369.56069.74
526281-2628172.50772.69
625729-2572970.98471.17
20min128266-2826677.98376.492.8478.3076.792.84
227059-2705974.65374.95
328855-2885579.60879.92
426913-2691374.25074.55
528076-2807677.45977.76
627177-2717774.97975.28
30min129676-2967681.87380.582.6182.3281.012.61
228630-2863078.98779.41
329982-2998282.71783.16
428373-2837378.27878.70
530009-3000982.79283.23
628567-2856778.81479.24
45min130889-3088985.22083.442.5285.8084.012.52
229608-2960881.68682.24
330454-3045484.02084.60
429196-2919680.54981.10
531206-3120686.09486.67
630119-3011983.09583.65
60min131219-3121986.13085.142.0286.8585.842.02
230480-3048084.09184.78
331089-3108985.77286.50
429925-2992582.56083.24
531703-3170387.46588.18
630743-3074384.81785.51
90min131858-3185887.89386.661.5588.7687.511.55
231171-3117185.99886.83
331316-3131686.39887.27
430599-3059984.42085.24
531733-3173387.54888.41
631787-3178787.69788.53
120min131518-3151886.95587.181.7687.9788.171.75
231413-3141386.66587.64
331435-3143586.72687.74
430786-3078684.93685.90
532113-3211388.59789.60
632335-3233589.20990.19
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131982-3198288.23588.160.8989.3989.290.90
231641-3164187.29488.41
332387-3238789.35390.51
431645-3164587.30588.41
531967-3196788.19489.35
632097-3209788.55289.68
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