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%
19.816175461984613066185961788617380.42
29.916287562009624420.99
单位质量响应值RSD%判断
6293.376300.910.09数据可信
加速6月-供试品溶液-2025072121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%
5min121750-2175030.98933.4211.9730.9933.4211.98
224004-2400434.20134.20
318939-1893926.98426.98
425553-2555336.40836.41
526825-2682538.22038.22
623660-2366033.71133.71
10min138150-3815054.35655.386.6954.4155.446.70
238471-3847154.81354.87
334457-3445749.09449.14
440753-4075358.06458.13
542001-4200159.84359.91
639401-3940156.13856.19
15min147408-4740867.54667.104.4767.6967.254.47
246237-4623765.87866.03
343494-4349461.97062.10
448712-4871269.40469.56
549470-4947070.48470.65
647259-4725967.33467.48
20min152060-5206074.17573.542.7474.4373.802.76
250491-5049171.93972.20
349468-4946870.48270.71
452693-5269375.07675.35
553275-5327575.90676.19
651718-5171873.68773.95
30min157777-5777782.32080.701.5782.7081.091.58
255893-5589379.63680.01
355640-5564079.27579.62
456652-5665280.71781.12
557622-5762282.09982.51
656276-5627680.18180.57
45min160064-6006485.57984.361.5586.0984.871.56
258491-5849183.33783.85
357949-5794982.56583.04
459762-5976285.14885.68
560153-6015385.70586.25
658821-5882183.80884.33
60min161581-6158187.74086.231.3288.4086.891.33
260339-6033985.97086.62
359605-5960584.92585.54
460493-6049386.19086.86
561328-6132887.38088.07
659786-5978685.18285.84
90min162837-6283789.53087.551.7090.3388.351.69
259822-5982285.23486.03
361513-6151387.64388.40
461381-6138187.45588.27
562212-6221288.63989.47
660932-6093286.81587.62
120min162576-6257689.15887.741.2390.1188.691.24
260511-6051186.21587.15
361186-6118687.17788.08
461807-6180788.06289.03
562188-6218888.60589.59
661221-6122187.22788.17
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165362-6536293.12791.491.1094.2392.581.09
263616-6361690.63991.72
364361-6436191.70192.75
463899-6389991.04392.15
564573-6457392.00393.13
663479-6347990.44491.53
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%
19.816277762207620216208262036622250.51
29.916349664002637490.57
单位质量响应值RSD%判断
6343.026432.801.00数据可信
加速6月-供试品溶液-2025072221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%
5min120008-2000828.10429.4712.6728.1029.4612.67
222837-2283732.07732.08
319475-1947527.35527.35
423353-2335332.80232.80
523374-2337432.83132.83
616822-1682223.62823.63
10min137389-3738952.51752.265.7452.5652.315.75
238615-3861554.23954.29
335690-3569050.13150.18
439145-3914554.98455.04
538723-3872354.39154.45
633683-3368347.31247.35
15min146642-4664265.51464.483.8065.6564.623.81
245906-4590664.48064.62
345051-4505163.27963.41
447509-4750966.73266.88
547424-4742466.61266.76
642895-4289560.25160.37
20min151595-5159572.47171.392.1872.7171.632.19
250933-5093371.54171.79
351447-5144772.26372.50
451532-5153272.38372.64
550770-5077071.31271.57
648675-4867568.37068.59
30min156425-5642579.25578.412.6479.6278.772.65
256111-5611178.81479.18
356659-5665979.58479.94
456203-5620378.94479.32
556668-5666879.59779.97
652856-5285674.24274.57
45min160142-6014284.47683.981.5984.9784.481.56
259345-5934583.35783.86
360122-6012284.44884.94
458258-5825881.83082.34
559767-5976783.95084.46
661099-6109985.82186.28
60min161807-6180786.81586.362.1387.4586.992.10
261043-6104385.74286.38
361116-6111685.84486.47
459965-5996584.22884.87
561109-6110985.83586.48
663858-6385889.69690.30
90min161952-6195287.01987.742.5787.8088.512.53
261884-6188486.92387.71
362224-6222487.40188.17
460842-6084285.46086.25
562321-6232187.53788.33
665552-6555292.07592.82
120min162410-6241087.66287.922.6788.5988.852.63
262323-6232387.54088.47
362974-6297488.45489.37
460809-6080985.41386.34
561443-6144386.30487.24
665617-6561792.16793.07
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164633-6463390.78490.531.1791.8691.601.15
264557-6455790.67891.75
363884-6388489.73290.80
463708-6370889.48590.56
564134-6413490.08491.16
665799-6579992.42293.48
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%
19.816370463995638646390863514637970.30
29.916400664150640780.16
单位质量响应值RSD%判断
6503.266465.990.41数据可信
加速6月-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%
5min117805-1780524.63528.427.1424.6428.427.13
221287-2128729.45329.45
321403-2140329.61329.61
421916-2191630.32330.32
520285-2028528.06628.07
620564-2056428.45228.45
10min133621-3362146.51850.314.0546.5650.354.05
236492-3649250.49150.54
336646-3664650.70450.75
437353-3735351.68251.73
536194-3619450.07850.13
637845-3784552.36352.41
15min144336-4433661.34463.121.9961.4663.252.00
244700-4470061.84761.98
346317-4631764.08564.22
446385-4638564.17964.32
545622-4562263.12363.25
646359-4635964.14364.28
20min148707-4870767.39169.842.3867.6170.082.38
249377-4937768.31868.55
351767-5176771.62571.87
451185-5118570.82071.06
550535-5053569.92170.16
651287-5128770.96171.20
30min154745-5474575.74676.951.8976.0877.301.89
254532-5453275.45175.80
356770-5677078.54778.91
455386-5538676.63276.99
557033-5703378.91179.26
655214-5521476.39476.75
45min157572-5757279.65781.582.3380.1282.062.32
257549-5754979.62580.10
360600-6060083.84784.34
459006-5900681.64182.13
560557-6055783.78784.27
658491-5849180.92981.42
60min159659-5965982.54584.372.4283.1484.982.42
259687-5968782.58383.19
363007-6300787.17787.81
460823-6082384.15584.78
562577-6257786.58287.21
660096-6009683.14983.77
90min161984-6198485.76186.322.3886.4987.082.38
260652-6065283.91984.66
363995-6399588.54489.32
462138-6213885.97586.74
564347-6434789.03189.80
661222-6122284.70785.47
120min163286-6328687.56387.212.2988.4488.112.28
261025-6102584.43585.32
364745-6474589.58290.51
462656-6265686.69187.60
564482-6448289.21890.13
661986-6198685.76486.67
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164265-6426588.91789.101.0989.9490.151.09
263358-6335887.66388.69
365174-6517490.17591.25
464053-6405388.62489.68
565183-6518390.18891.25
664364-6436489.05490.10
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