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%
110.386625166627664236641965998663440.36
210.406793268443681880.53
单位质量响应值RSD%判断
6391.526556.541.81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%
5min118495-1849525.63623.936.0225.6423.946.02
217732-1773224.57824.58
318121-1812125.11725.12
416788-1678823.27023.27
516771-1677123.24623.25
615697-1569721.75721.76
10min128489-2848939.48837.644.3439.5337.684.34
227352-2735237.91237.95
328356-2835639.30439.35
426649-2664936.93836.98
526741-2674137.06537.10
625352-2535235.14035.18
15min134620-3462047.98646.233.3748.0946.333.37
233110-3311045.89346.00
334703-3470348.10148.21
432792-3279245.45345.55
533110-3311045.89345.99
631794-3179444.06944.16
20min138383-3838353.20251.652.4953.3951.832.49
236902-3690251.14951.33
338365-3836553.17753.36
437199-3719951.56151.74
536572-3657250.69250.87
636158-3615850.11850.29
30min143484-4348460.27358.971.9660.5559.241.96
242128-4212858.39358.66
343692-4369260.56160.84
441688-4168857.78358.05
542221-4222158.52258.78
642060-4206058.29958.55
45min148102-4810266.67365.391.8867.0565.751.88
247034-4703465.19365.56
348251-4825166.88067.26
446973-4697365.10965.47
546801-4680164.87065.23
645880-4588063.59463.94
60min151827-5182771.83769.881.9672.3370.351.96
249784-4978469.00569.48
351449-5144971.31371.80
449830-4983069.06969.54
549433-4943368.51868.99
650149-5014969.51169.97
90min154456-5445675.48174.051.6076.0974.641.61
252239-5223972.40872.99
354354-5435475.33975.95
453287-5328773.86074.44
552910-5291073.33873.92
653284-5328473.85674.43
120min157060-5706079.09077.281.9479.8277.991.94
254708-5470875.83076.54
357178-5717879.25479.99
455307-5530776.66077.37
555063-5506376.32277.03
655191-5519176.49977.19
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158366-5836680.90079.191.4581.7780.031.46
256703-5670378.59579.43
357869-5786980.21181.08
457081-5708179.11979.95
556402-5640278.17879.01
656352-5635278.10978.93
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%
110.386716767178676806686666557670900.63
210.406820768595684010.41
单位质量响应值RSD%判断
6463.396577.021.24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%
5min117638-1763824.27321.4013.2024.2721.4013.20
217695-1769524.35124.35
316661-1666122.92822.93
413594-1359418.70718.71
514698-1469820.22720.23
613035-1303517.93817.94
10min128095-2809538.66336.745.3438.7036.785.34
227821-2782138.28638.33
327451-2745137.77737.81
424251-2425133.37333.40
526158-2615835.99736.03
626428-2642836.36936.40
15min134663-3466347.70145.744.4047.8145.844.40
234431-3443147.38247.49
333701-3370146.37846.48
430636-3063642.16042.25
533212-3321245.70545.80
632769-3276945.09545.19
20min138816-3881653.41751.443.2653.6051.623.27
238654-3865453.19453.38
337604-3760451.74951.93
435827-3582749.30349.46
537086-3708651.03651.21
636297-3629749.95050.12
30min144119-4411960.71458.912.4560.9959.172.46
243796-4379660.27060.54
343165-4316559.40259.67
441628-4162857.28657.53
542332-4233258.25558.51
641791-4179157.51157.76
45min149046-4904667.49565.971.9167.8766.331.92
248478-4847866.71367.09
348448-4844866.67267.04
446936-4693664.59164.93
547968-4796866.01166.36
646765-4676564.35664.70
60min152630-5263072.42770.572.2772.9171.042.28
251997-5199771.55672.04
352347-5234772.03772.51
450135-5013568.99369.44
550205-5020569.09069.55
650378-5037869.32869.78
90min156578-5657877.86075.611.9778.4776.191.98
255498-5549876.37476.98
355446-5544676.30276.90
454008-5400874.32374.88
554352-5435274.79775.37
653765-5376573.98974.56
120min158165-5816580.04479.051.9080.7879.761.91
258168-5816880.04880.78
358421-5842180.39681.12
457089-5708978.56379.24
557336-5733678.90379.60
655498-5549876.37477.06
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158338-5833880.28279.761.3481.1580.601.35
258754-5875480.85481.72
358545-5854580.56781.42
457952-5795279.75180.56
557498-5749879.12679.96
656665-5666577.98078.80
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%
110.386905269028690246892468623689300.26
210.406980869173694900.65
单位质量响应值RSD%判断
6640.666681.730.44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%
5min117356-1735623.37723.184.2823.3823.184.28
217420-1742023.46423.46
317556-1755623.64723.65
415883-1588321.39321.39
518052-1805224.31524.31
616979-1697922.87022.87
10min127596-2759637.17036.893.0937.2136.933.09
227575-2757537.14237.18
326800-2680036.09836.14
426321-2632135.45335.49
528798-2879838.78938.83
627243-2724336.69536.73
15min134191-3419146.05345.321.9046.1545.421.90
233766-3376645.48145.58
333228-3322844.75644.86
432679-3267944.01644.11
534427-3442746.37146.48
633605-3360545.26445.36
20min138251-3825151.52250.761.3051.7050.941.30
237357-3735750.31750.49
337455-3745550.44950.62
437048-3704849.90150.07
538215-3821551.47351.66
637805-3780550.92151.10
30min143343-4334358.38058.120.9358.6458.380.93
243025-4302557.95258.21
343011-4301157.93358.19
442592-4259257.36957.62
543791-4379158.98459.25
643137-4313758.10358.36
45min148210-4821064.93664.161.0765.3064.521.07
247150-4715063.50863.87
347824-4782464.41664.77
447197-4719763.57163.92
548209-4820964.93465.30
647228-4722863.61363.97
60min151371-5137169.19368.490.6469.6668.950.64
250637-5063768.20568.67
350759-5075968.36968.83
450720-5072068.31668.77
551086-5108668.80969.28
650502-5050268.02368.49
90min155426-5542674.65573.471.4575.2474.051.45
253617-5361772.21972.80
354299-5429973.13773.71
454073-5407372.83373.40
555607-5560774.89975.49
654263-5426373.08973.66
120min157195-5719577.03876.071.1277.7576.781.12
256201-5620175.69976.40
356326-5632675.86776.57
456061-5606175.51076.20
557314-5731477.19877.91
655779-5577975.13175.83
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158052-5805278.19277.211.4079.0378.041.40
256730-5673076.41277.23
356818-5681876.53077.35
456555-5655576.17676.99
558541-5854178.85179.69
657254-5725477.11777.94
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