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%
19.946397164253642736400363832640660.30
210.006405064274641620.25
单位质量响应值RSD%判断
6445.276416.200.32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%
5min122562-2256231.47833.209.9631.4833.209.95
224279-2427933.87433.87
319918-1991827.79027.79
426838-2683837.44437.44
523968-2396833.44033.44
625194-2519435.15135.15
10min135527-3552749.56752.169.5549.6252.219.56
236773-3677351.30651.36
332194-3219444.91744.96
440971-4097157.16357.23
536983-3698351.59951.65
641845-4184558.38258.44
15min143293-4329360.40261.567.1060.5461.707.10
244142-4414261.58761.73
338719-3871954.02154.14
447283-4728365.96966.13
544168-4416861.62361.76
647134-4713465.76165.92
20min147478-4747866.24167.235.9366.4867.475.94
248737-4873767.99868.24
343121-4312160.16260.37
451066-5106671.24771.51
548091-4809167.09667.34
650625-5062570.63270.90
30min153280-5328074.33673.594.4974.6873.954.51
253498-5349874.64075.00
348176-4817667.21567.53
454861-5486176.54276.93
552585-5258573.36673.72
654091-5409175.46875.85
45min156851-5685179.31878.153.4079.7978.623.41
256767-5676779.20179.68
352392-5239273.09773.52
457656-5765680.44280.96
555530-5553077.47577.95
656865-5686579.33879.85
60min158684-5868481.87680.803.2582.4881.413.26
258765-5876581.98982.60
354140-5414075.53676.08
458626-5862681.79582.44
558118-5811881.08681.69
659146-5914682.52083.16
90min160950-6095085.03783.842.5985.7884.592.61
260538-6053884.46285.21
356962-5696279.47380.14
460444-6044484.33185.12
560567-6056784.50385.25
661094-6109485.23886.02
120min161849-6184986.29285.282.2587.1786.162.27
261380-6138085.63786.53
358702-5870281.90182.70
460974-6097485.07186.00
561002-6100285.11085.99
662822-6282287.64988.57
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162487-6248787.18286.562.2088.2187.592.22
262213-6221386.79987.83
359522-5952283.04583.99
462164-6216486.73187.80
562193-6219386.77287.80
663678-6367888.84389.91
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%
19.946479864766651236469464554647870.33
210.006439964276643380.14
单位质量响应值RSD%判断
6517.816433.800.92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%
5min122441-2244131.09334.105.5831.0934.105.58
223734-2373432.88432.88
324893-2489334.49034.49
425566-2556635.42335.42
524728-2472834.26234.26
626320-2632036.46736.47
10min138135-3813552.83855.014.4952.8955.074.50
237500-3750051.95852.01
339114-3911454.19454.25
441734-4173457.82457.88
540056-4005655.49955.56
641699-4169957.77657.84
15min145559-4555963.12465.173.3663.2665.323.36
245049-4504962.41762.56
346869-4686964.93965.09
448886-4888667.73367.89
547147-4714765.32465.47
648720-4872067.50367.66
20min150010-5001069.29170.832.1969.5471.092.19
249924-4992469.17269.42
350908-5090870.53570.79
452544-5254472.80273.07
551009-5100970.67570.93
652332-5233272.50872.78
30min154621-5462175.68076.452.3676.0476.822.37
253157-5315773.65174.01
355045-5504576.26776.64
456906-5690678.84579.24
555119-5511976.37076.75
656193-5619377.85878.25
45min157794-5779480.07680.381.7980.5680.881.79
256350-5635078.07578.56
357572-5757279.76880.27
459380-5938082.27382.79
558444-5844480.97681.48
658557-5855781.13381.65
60min159514-5951482.45982.251.9383.0882.881.93
257440-5744079.58580.20
359494-5949482.43183.06
460981-6098184.49285.15
559104-5910481.89182.53
659635-5963582.62783.28
90min160061-6006183.21784.682.2783.9785.462.28
259003-5900381.75182.50
361494-6149485.20285.97
462812-6281287.02887.83
561240-6124084.85085.63
662112-6211286.05986.85
120min161136-6113684.70685.411.8985.6086.331.90
259579-5957982.54983.43
361742-6174285.54686.46
462427-6242786.49587.44
562185-6218586.16087.08
662805-6280587.01987.96
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162757-6275786.95286.931.5887.9987.981.58
261071-6107184.61685.64
362378-6237886.42787.48
463863-6386388.48589.57
562807-6280787.02288.08
663557-6355788.06189.14
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%
19.946550265199652046460664588650200.63
210.006666966410665400.28
单位质量响应值RSD%判断
6541.256654.001.21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%
5min123254-2325431.62532.926.2031.6332.926.20
222251-2225130.26130.26
324981-2498133.97433.97
424067-2406732.73132.73
526631-2663136.21836.22
624049-2404932.70732.71
10min136618-3661849.80050.823.0849.8550.873.09
235856-3585648.76448.81
337381-3738150.83850.89
438034-3803451.72651.78
539175-3917553.27853.34
637136-3713650.50550.56
15min144203-4420360.11660.931.6260.2561.061.63
244366-4436660.33860.47
345098-4509861.33361.47
445361-4536161.69161.83
545797-4579762.28462.43
643972-4397259.80259.94
20min148343-4834365.74666.531.7565.9866.771.76
248201-4820165.55365.79
348683-4868366.20966.45
449793-4979367.71867.96
550188-5018868.25668.51
648299-4829965.68765.92
30min152947-5294772.00873.021.5372.3573.371.53
254129-5412973.61573.96
352757-5275771.74972.10
454279-5427973.81974.18
554774-5477474.49374.86
653242-5324272.40972.76
45min156986-5698677.50178.471.6677.9778.951.66
257684-5768478.45078.91
356457-5645776.78177.25
458611-5861179.71180.19
558972-5897280.20280.69
657498-5749878.19778.67
60min158857-5885780.04580.912.1780.6481.522.17
260142-6014281.79382.39
357432-5743278.10778.71
460275-6027581.97482.59
561082-6108283.07183.70
659163-5916380.46281.06
90min160316-6031682.03083.461.9582.7684.201.95
261609-6160983.78884.52
359896-5989681.45882.19
462476-6247684.96785.72
562929-6292985.58386.35
660992-6099282.94983.68
120min160810-6081082.70184.122.1083.5785.002.09
261919-6191984.21085.08
360154-6015481.80982.68
463053-6305385.75286.64
563553-6355386.43287.34
661628-6162883.81484.69
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162454-6245484.93785.301.7885.9486.321.79
262637-6263785.18686.20
361072-6107283.05884.06
463811-6381186.78387.82
564137-6413787.22688.28
662232-6223284.63585.65
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