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%
110.076590665856664376619966022660840.36
210.226647366380664260.10
单位质量响应值RSD%判断
6562.466499.610.69数据可信
供试品溶液-2025072121批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110192-1019214.00213.307.6214.0013.307.63
210128-1012813.91413.91
39153-915312.57412.57
49861-986113.54713.55
510328-1032814.18914.19
68444-844411.60011.60
10min118011-1801124.74323.773.4024.7723.803.40
217678-1767824.28624.31
317015-1701523.37523.40
417276-1727623.73423.76
517515-1751524.06224.09
616326-1632622.42922.45
15min122831-2283131.36530.472.5631.4330.542.56
222244-2224430.55930.62
322027-2202730.26130.32
422233-2223330.54430.61
522577-2257731.01631.08
621181-2118129.09829.16
20min125910-2591035.59535.101.3635.7135.221.36
225547-2554735.09635.21
325323-2532334.78934.90
425559-2555935.11335.23
525942-2594235.63935.75
625039-2503934.39834.50
30min130388-3038841.74741.731.2041.9241.901.20
230393-3039341.75441.93
330461-3046141.84742.02
429926-2992641.11241.28
530981-3098142.56242.74
630096-3009641.34641.51
45min135655-3565548.98348.301.2549.2348.541.26
235144-3514448.28148.52
335016-3501648.10548.34
434795-3479547.80148.04
535702-3570249.04749.29
634639-3463947.58747.82
60min138881-3888153.41552.631.0453.7452.951.05
238305-3830552.62352.95
338088-3808852.32552.64
438114-3811452.36152.68
538671-3867153.12653.45
637816-3781651.95152.26
90min142717-4271758.68458.480.9559.1058.890.95
242699-4269958.66059.07
342292-4229258.10158.51
442627-4262758.56158.97
543122-4312259.24159.66
641948-4194857.62858.03
120min145689-4568962.76761.971.1063.2862.481.10
245304-4530462.23862.75
344752-4475261.48061.98
444779-4477961.51762.02
545611-4561162.66063.17
644514-4451461.15361.65
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146431-4643163.78763.550.9064.4164.160.90
246314-4631463.62664.24
346439-4643963.79864.40
445996-4599663.18963.80
546782-4678264.26964.89
645594-4559462.63763.23
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%
110.076683566319663666649966162664360.39
210.226646665754661100.77
单位质量响应值RSD%判断
6597.426468.691.40数据可信
供试品溶液-2025072121批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19743-974313.38212.1518.8113.3812.1518.80
26595-65959.0589.06
36930-69309.5189.52
410402-1040214.28714.29
510153-1015313.94513.94
69265-926512.72512.73
10min117288-1728823.74522.7810.2123.7722.8010.21
213960-1396019.17419.19
315129-1512920.77920.80
418010-1801024.73624.76
518225-1822525.03225.05
616909-1690923.22423.25
15min122250-2225030.56029.806.1530.6229.866.16
219548-1954826.84926.90
320681-2068128.40528.46
422925-2292531.48731.55
522876-2287631.42031.48
621917-2191730.10230.16
20min125624-2562435.19434.794.3835.3134.904.39
223364-2336432.09032.18
324742-2474233.98234.08
426056-2605635.78735.90
526353-2635336.19536.31
625836-2583635.48535.60
30min129950-2995041.13641.453.1741.3141.623.18
228802-2880239.55939.70
329386-2938640.36140.52
430975-3097542.54342.72
531150-3115042.78442.96
630807-3080742.31342.48
45min135416-3541648.64348.313.0248.8848.553.03
233366-3336645.82746.04
334464-3446447.33547.56
435872-3587249.26949.52
536085-3608549.56249.81
635851-3585149.24049.48
60min138964-3896453.51653.122.1753.8453.442.19
237400-3740051.36851.66
337948-3794852.12152.42
439547-3954754.31754.65
539377-3937754.08354.41
638818-3881853.31553.64
90min143438-4343859.66159.021.9160.0759.421.93
241817-4181757.43557.81
342094-4209457.81558.20
443526-4352659.78260.20
543808-4380860.16960.59
643123-4312359.22859.64
120min145821-4582162.93462.771.2163.4463.271.23
244674-4467461.35961.83
345617-4561762.65463.14
446143-4614363.37663.90
546189-4618963.43963.96
645769-4576962.86263.37
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146820-4682064.30664.110.9864.9264.721.00
245905-4590563.04963.62
346415-4641563.75064.34
446745-4674564.20364.83
547118-4711864.71565.34
647060-4706064.63665.25
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%
110.076650067183667736607166858666770.63
210.226889969114690060.23
单位质量响应值RSD%判断
6621.356752.051.39数据可信
供试品溶液-2025072221批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19646-964612.94413.042.5512.9413.042.55
29315-931512.50012.50
39722-972213.04613.05
49714-971413.03513.04
510075-1007513.52013.52
69825-982513.18413.18
10min116345-1634521.93422.432.3321.9622.452.33
216418-1641822.03122.05
316641-1664122.33122.35
416649-1664922.34122.36
517429-1742923.38823.41
616815-1681522.56422.59
15min120710-2071027.79128.982.1627.8529.042.16
221748-2174829.18429.24
321554-2155428.92428.98
421903-2190329.39229.45
522017-2201729.54529.61
621646-2164629.04729.11
20min124704-2470433.15133.691.2533.2633.801.25
224925-2492533.44733.55
325160-2516033.76233.87
425416-2541634.10634.21
525505-2550534.22534.34
624924-2492433.44633.55
30min129932-2993240.16640.070.4140.3340.240.42
229735-2973539.90240.06
329762-2976239.93840.10
429982-2998240.23340.40
529994-2999440.24940.42
629764-2976439.94140.10
45min133926-3392645.52646.150.7145.7546.380.72
234531-3453146.33846.57
334336-3433646.07646.31
434474-3447446.26146.49
534475-3447546.26246.50
634601-3460146.43146.66
60min137729-3772950.62950.790.7050.9351.100.70
237661-3766150.53850.84
337539-3753950.37450.68
438270-3827051.35551.66
537961-3796150.94051.25
637942-3794250.91551.22
90min141656-4165655.89956.190.6256.2956.580.62
242118-4211856.51956.91
341627-4162755.86056.25
441919-4191956.25256.65
542233-4223356.67357.07
641687-4168755.94056.33
120min144636-4463659.89860.080.5360.3860.560.53
244809-4480960.13060.61
344449-4444959.64760.13
445062-4506260.46960.96
545013-4501360.40360.89
644652-4465259.91960.40
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145638-4563861.24261.370.3261.8261.950.32
245952-4595261.66362.25
345717-4571761.34861.93
445670-4567061.28561.87
545852-4585261.52962.12
645566-4556661.14561.73
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%
110.076637465956658876661566127661920.46
210.226852068132683260.41
单位质量响应值RSD%判断
6573.196685.521.20数据可信
供试品溶液-2025072221批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110046-1004613.59712.4212.6613.6012.4212.68
28417-841711.39211.39
37272-72729.8439.84
49088-908812.30012.30
510251-1025113.87513.87
69965-996513.48713.49
10min117537-1753723.73622.197.5423.7622.227.54
216083-1608321.76821.79
314148-1414819.14919.17
416291-1629122.05022.07
517176-1717623.24723.27
617143-1714323.20323.23
15min122074-2207429.87729.044.8729.9429.094.88
221516-2151629.12229.18
319460-1946026.33926.39
421298-2129828.82728.88
522158-2215829.99130.05
622211-2221130.06230.12
20min125984-2598435.16933.674.0835.2833.784.09
224830-2483033.60733.71
323085-2308531.24531.34
424550-2455033.22833.33
525500-2550034.51434.63
625327-2532734.28034.39
30min130618-3061841.44140.312.5541.6140.472.56
230029-3002940.64440.80
328508-2850838.58538.73
429289-2928939.64239.80
530221-3022140.90441.07
630018-3001840.62940.80
45min135759-3575948.39946.632.6848.6446.862.69
234443-3444346.61846.85
333022-3302244.69544.90
434037-3403746.06946.30
535013-3501347.39047.63
634451-3445146.62946.87
60min138701-3870152.38151.002.5452.7051.302.54
238166-3816651.65751.96
336240-3624049.05049.33
436776-3677649.77650.08
538226-3822651.73852.05
637963-3796351.38251.70
90min142818-4281857.95456.802.0158.3657.192.01
242582-4258257.63458.03
340481-4048154.79155.16
441598-4159856.30256.69
542120-4212057.00957.41
642197-4219757.11357.51
120min145375-4537561.41460.481.4761.9260.961.48
244803-4480360.64061.13
343710-4371059.16159.62
444062-4406259.63760.12
545118-4511861.06761.56
645019-4501960.93361.43
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146490-4649062.92461.861.7263.5362.451.73
246296-4629662.66163.25
344279-4427959.93160.49
445581-4558161.69362.27
545659-4565961.79962.40
645942-4594262.18262.78
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