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10000
标示量(mg)1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%
110.386764566617668736681866909669720.59
210.406792667618677720.33
单位质量响应值RSD%判断
6452.026516.540.71数据可信
供试品溶液-2025072521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%
5min117786-1778624.61123.426.4324.6123.426.44
216141-1614122.33422.33
317444-1744424.13724.14
417356-1735624.01624.02
515070-1507020.85220.85
617738-1773824.54424.54
10min127488-2748838.03537.083.9938.0837.123.99
226938-2693837.27437.31
327527-2752738.08938.13
426714-2671436.96437.00
524727-2472734.21534.25
627412-2741237.93037.97
15min133499-3349946.35345.412.3946.4645.512.39
233062-3306245.74845.85
333252-3325246.01146.11
432952-3295245.59645.70
531294-3129443.30243.39
632831-3283145.42845.53
20min137373-3737351.71350.831.8651.8951.001.86
237080-3708051.30851.48
337173-3717351.43651.62
436331-3633150.27150.45
535548-3554849.18849.35
636900-3690051.05951.24
30min142264-4226458.48158.051.5558.7558.311.55
242712-4271259.10159.36
342273-4227358.49358.76
441339-4133957.20157.46
540999-4099956.73056.98
642127-4212758.29158.56
45min146718-4671864.64464.481.4265.0164.841.41
247396-4739665.58265.94
347248-4724865.37765.74
445645-4564563.15963.52
546271-4627164.02564.37
646327-4632764.10364.46
60min150073-5007369.28668.731.8069.7669.191.79
250678-5067870.12370.59
350394-5039469.73070.20
448260-4826066.77867.24
549269-4926968.17468.62
649332-4933268.26168.73
90min153892-5389274.57173.222.0175.1673.802.01
253994-5399474.71275.30
353635-5363574.21574.80
451447-5144771.18771.76
552179-5217972.20072.76
652353-5235372.44173.02
120min155070-5507076.20175.981.8176.9176.681.80
255838-5583877.26377.97
356128-5612877.66578.38
453431-5343173.93374.62
554524-5452475.44576.13
654466-5446675.36576.07
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157025-5702578.90678.301.6079.7579.131.60
257338-5733879.33980.18
357703-5770379.84480.69
455468-5546876.75177.57
555764-5576477.16177.97
656221-5622177.79378.62
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10000
标示量(mg)1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%
110.386723167001666936686366572668720.39
210.406814468478683110.35
单位质量响应值RSD%判断
6442.396568.371.37数据可信
供试品溶液-2025072421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%
5min117283-1728323.83924.044.0123.8424.044.01
217073-1707323.54923.55
316935-1693523.35923.36
418483-1848325.49425.49
518078-1807824.93524.94
616712-1671223.05123.05
10min127289-2728937.64038.292.6437.6838.342.64
227531-2753137.97438.01
326932-2693237.14837.19
428858-2885839.80439.85
528438-2843839.22539.27
627529-2752937.97138.01
15min133156-3315645.73246.221.9345.8346.331.93
233417-3341746.09246.19
332536-3253644.87744.98
434323-3432347.34247.45
534082-3408247.01047.12
633560-3356046.29046.39
20min136963-3696350.98351.751.8551.1651.931.85
237883-3788352.25252.43
336457-3645750.28650.46
438297-3829752.82353.01
537977-3797752.38252.57
637523-3752351.75651.93
30min142497-4249758.61759.021.5158.8859.291.52
242974-4297459.27559.54
341705-4170557.52457.78
443591-4359160.12660.40
543171-4317159.54659.82
642815-4281559.05559.32
45min147269-4726965.19965.881.6465.5666.251.64
247941-4794166.12666.49
346462-4646264.08664.44
448556-4855666.97467.35
548405-4840566.76667.14
647962-4796266.15566.52
60min149913-4991368.84669.861.5669.3270.331.56
250704-5070469.93770.41
349635-4963568.46268.92
451779-5177971.41971.91
550719-5071969.95770.44
651133-5113370.52871.00
90min153556-5355673.87075.221.9174.4675.821.91
254596-5459675.30575.90
353054-5305473.17873.75
455799-5579976.96477.57
555172-5517276.09976.70
655042-5504275.92076.51
120min156282-5628277.63078.301.5978.3479.021.59
256630-5663078.11078.83
355476-5547676.51977.22
458068-5806880.09480.83
557427-5742779.21079.94
656737-5673778.25878.98
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156620-5662078.09779.281.2578.9380.131.26
257315-5731579.05579.90
356780-5678078.31779.14
458306-5830680.42281.29
558262-5826280.36181.22
657592-5759279.43780.29
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10000
标示量(mg)1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%
110.386877568667686576852268238685720.31
210.406959469731696620.14
单位质量响应值RSD%判断
6606.176698.270.98数据可信
供试品溶液-2025072522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%
5min116081-1608121.69022.633.9221.6922.623.92
216853-1685322.73122.73
316777-1677722.62922.63
415972-1597221.54321.54
517392-1739223.45823.46
617574-1757423.70423.70
10min125203-2520333.99435.893.0934.0335.933.08
227021-2702136.44636.48
326823-2682336.17936.22
426076-2607635.17135.21
527382-2738236.93336.97
627143-2714336.61136.65
15min131757-3175742.83444.291.7742.9344.391.78
233126-3312644.68044.78
332961-3296144.45844.56
432673-3267344.06944.16
533415-3341545.07045.17
633085-3308544.62544.73
20min135941-3594148.47749.731.4248.6449.901.43
237081-3708150.01550.19
336676-3667649.46949.64
436934-3693449.81749.98
537453-3745350.51750.69
637145-3714550.10150.28
30min141447-4144755.90456.831.1456.1557.081.15
242350-4235057.12257.38
342358-4235857.13357.39
441883-4188356.49256.74
542824-4282457.76158.02
641925-4192556.54956.81
45min146596-4659662.84963.360.9563.1963.710.95
246795-4679563.11763.47
346619-4661962.88063.23
447285-4728563.77864.12
547725-4772564.37264.73
646842-4684263.18163.53
60min149496-4949666.76067.340.9067.2067.790.90
249900-4990067.30567.76
350121-5012167.60368.06
449566-4956666.85567.31
550712-5071268.40068.86
649741-4974167.09167.55
90min152937-5293771.40272.240.9371.9672.810.93
253815-5381572.58673.15
353298-5329871.88872.46
453821-5382172.59473.16
554278-5427873.21073.79
653204-5320471.76272.33
120min155602-5560274.99675.370.9875.6776.050.97
255948-5594875.46376.15
355388-5538874.70775.39
455813-5581375.28175.96
556911-5691176.76277.46
655603-5560374.99775.69
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156323-5632375.96976.411.4476.7777.221.43
255791-5579175.25176.07
356941-5694176.80277.61
456423-5642376.10476.91
558135-5813578.41379.24
656289-5628975.92376.74
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