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%
110.163296633041334563310833066331270.58
210.243349033487334880.01
单位质量响应值RSD%判断
3260.533270.310.22数据可信
供试品溶液-2025042721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%
5min110455-1045528.72628.375.0528.7328.375.04
29734-973426.74526.75
310877-1087729.88629.89
49625-962526.44626.45
510694-1069429.38329.38
610567-1056729.03429.03
10min117504-1750448.09447.851.6648.1447.901.66
217296-1729647.52347.57
317645-1764548.48248.53
417123-1712347.04747.09
517110-1711047.01247.06
617816-1781648.95149.00
15min120960-2096057.59057.611.3457.7257.741.34
220525-2052556.39556.52
321070-2107057.89258.02
421050-2105057.83757.96
520829-2082957.23057.36
621369-2136958.71458.84
20min123005-2300563.20963.871.0463.4364.091.05
223082-2308263.42063.64
323374-2337464.22364.45
423071-2307163.39063.61
523295-2329564.00664.23
623643-2364364.96265.19
30min125949-2594971.29871.250.8171.6371.580.82
225888-2588871.13071.45
325899-2589971.16071.49
425854-2585471.03771.36
525684-2568470.57070.90
626319-2631972.31472.65
45min128253-2825377.62877.801.5678.0878.251.56
227757-2775776.26676.71
328382-2838277.98378.44
428007-2800776.95277.40
528434-2843478.12678.57
629054-2905479.82980.29
60min129566-2956681.23681.651.0481.8182.231.04
229382-2938280.73081.30
329725-2972581.67382.26
429480-2948081.00081.57
529962-2996282.32482.90
630189-3018982.94883.54
90min130867-3086784.81185.171.3685.5285.891.36
230431-3043183.61384.32
331157-3115785.60786.33
430825-3082584.69585.40
531017-3101785.22385.94
631696-3169687.08887.82
120min131579-3157986.76787.550.8287.6288.410.82
231826-3182687.44688.29
331748-3174887.23188.09
431774-3177487.30388.15
531915-3191587.69088.55
632344-3234488.86989.74
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132244-3224488.59488.500.8789.5989.500.87
232167-3216788.38389.37
332380-3238088.96889.97
431750-3175087.23788.23
532139-3213988.30689.31
632583-3258389.52690.55
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%
110.163328933228333633306533356332600.37
210.243320533129331670.17
单位质量响应值RSD%判断
3273.623238.960.76数据可信
供试品溶液-2025042721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%
5min17870-787021.68524.1317.2221.6824.1317.22
29851-985127.14327.14
37508-750820.68720.69
46932-693219.10019.10
59759-975926.89026.89
610622-1062229.26829.27
10min115410-1541042.46144.368.5942.5044.408.60
217268-1726847.58047.63
314801-1480140.78340.82
414412-1441239.71139.74
517252-1725247.53647.58
617458-1745848.10448.15
15min119292-1929253.15755.775.5553.2655.885.56
221375-2137558.89659.02
319270-1927053.09653.20
419123-1912352.69152.79
520967-2096757.77257.90
621418-2141859.01559.14
20min122062-2206260.78962.783.7460.9862.993.75
223948-2394865.98666.21
322022-2202260.67960.87
422029-2202960.69860.88
523344-2334464.32264.54
623306-2330664.21764.44
30min125059-2505969.04770.942.7469.3471.252.76
226676-2667673.50373.84
324994-2499468.86869.16
425410-2541070.01470.30
525931-2593171.45071.78
626408-2640872.76473.10
45min127640-2764076.15977.802.0876.5778.232.09
228798-2879879.35079.80
327446-2744675.62476.03
428201-2820177.70578.11
528500-2850078.52978.98
628824-2882479.42179.88
60min129111-2911180.21281.871.9780.7582.421.99
230576-3057684.24984.84
329084-2908480.13880.67
429588-2958881.52682.06
529758-2975881.99582.57
630149-3014983.07283.66
90min130652-3065284.45885.722.0685.1386.422.07
231838-3183887.72688.45
330066-3006682.84483.51
431284-3128486.20086.87
531350-3135086.38187.10
631475-3147586.72687.45
120min131486-3148686.75688.441.8287.5789.281.83
233014-3301490.96691.84
331462-3146286.69087.49
432325-3232589.06889.88
532037-3203788.27489.13
632269-3226988.91489.78
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132093-3209388.42989.221.2889.3990.211.30
232761-3276190.26991.29
331876-3187687.83188.78
432194-3219488.70789.67
532393-3239389.25590.26
632965-3296590.83191.85
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%
110.166584066419660816604566229661230.33
210.246736467216672900.16
单位质量响应值RSD%判断
6508.176571.290.69数据可信
供试品溶液-2025042722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%
5min117413-1741323.89021.7714.0723.8921.7714.07
213473-1347318.48518.48
312590-1259017.27317.27
417649-1764924.21424.21
517244-1724423.65823.66
616849-1684923.11623.12
10min128799-2879939.51138.046.2139.5538.076.21
226419-2641936.24636.28
324810-2481034.03934.07
428961-2896139.73439.77
528882-2888239.62539.66
628474-2847439.06539.10
15min135519-3551948.73147.532.9848.8447.632.99
233882-3388246.48546.58
333040-3304045.33045.42
435029-3502948.05948.17
535762-3576249.06449.17
634614-3461447.48947.59
20min139598-3959854.32753.641.7154.5153.821.72
238951-3895153.44053.61
337871-3787151.95852.12
439430-3943054.09754.28
539666-3966654.42154.61
639071-3907153.60453.79
30min144957-4495761.68061.321.1261.9661.591.13
244252-4425260.71260.97
344154-4415460.57860.83
444509-4450961.06561.34
545486-4548662.40562.68
644831-4483161.50761.78
45min150249-5024968.94068.580.5669.3268.950.56
249858-4985868.40468.76
350055-5005568.67469.02
449628-4962868.08868.47
550345-5034569.07269.45
649785-4978568.30468.68
60min152708-5270872.31472.950.8172.8173.440.81
253134-5313472.89873.37
353217-5321773.01273.48
453076-5307672.81973.31
553971-5397174.04774.54
652940-5294072.63273.12
90min156336-5633677.29178.080.8177.9178.680.79
257041-5704178.25978.85
357317-5731778.63779.22
456657-5665777.73278.35
557516-5751678.91079.53
656589-5658977.63878.25
120min158526-5852680.29680.910.7681.0481.650.75
259126-5912681.11981.84
359341-5934181.41482.13
458882-5888280.78481.53
559540-5954081.68782.44
658426-5842680.15980.90
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160223-6022382.62482.480.7983.5083.350.77
260368-6036882.82383.68
360715-6071583.29984.15
459950-5995082.25083.13
560141-6014182.51283.40
659306-5930681.36682.24
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%
110.166589665900657776628966041659810.30
210.246764667561676040.09
单位质量响应值RSD%判断
6494.196601.951.17数据可信
供试品溶液-2025042722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%
5min118492-1849225.33921.0220.3325.3421.0220.34
214711-1471120.15820.16
311759-1175916.11316.11
417017-1701723.31823.32
518375-1837525.17925.18
611679-1167916.00416.00
10min129253-2925340.08536.9310.5240.1336.9710.53
226495-2649536.30636.34
323420-2342032.09232.12
428788-2878839.44839.49
529943-2994341.03041.07
623808-2380832.62432.65
15min135706-3570648.92746.666.2949.0446.756.31
234158-3415846.80646.90
331149-3114942.68342.76
435328-3532848.40948.51
536221-3622149.63349.74
631731-3173143.48043.56
20min140185-4018555.06553.314.2155.2653.484.23
239110-3911053.59253.76
336911-3691150.57850.73
439462-3946254.07454.26
540797-4079755.90356.10
636943-3694350.62250.78
30min145475-4547562.31461.682.6262.6061.942.65
245436-4543662.26062.52
343362-4336259.41859.65
445646-4564662.54862.82
546388-4638863.56563.85
643777-4377759.98760.22
45min150741-5074169.52968.912.0069.9269.272.02
250245-5024568.85069.22
348835-4883566.91867.25
450994-5099469.87670.26
551485-5148570.54970.94
649417-4941767.71568.05
60min154444-5444474.60473.521.6375.1174.001.66
253667-5366773.53974.02
352466-5246671.89372.34
453800-5380073.72174.22
554701-5470174.95675.47
652843-5284372.41072.86
90min157480-5748078.76478.921.2779.3979.521.29
257536-5753678.84179.44
356770-5677077.79178.36
457904-5790479.34579.96
558830-5883080.61481.25
657023-5702378.13878.71
120min159756-5975681.88382.061.1382.6482.791.15
260359-6035982.70983.44
359622-5962281.69982.39
459735-5973581.85482.61
560899-6089983.44984.22
658929-5892980.74981.45
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160275-6027582.59483.020.8783.4983.890.88
260667-6066783.13184.00
360727-6072783.21384.05
460579-6057983.01083.90
561413-6141384.15385.06
659842-5984282.00082.84
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