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%
110.146638166737660446620166289663300.40
210.146655966243664010.34
单位质量响应值RSD%判断
6541.426548.420.08数据可信
供试品溶液-2025072121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%
5min115176-1517620.80420.586.0320.8020.576.02
215912-1591221.81321.81
314985-1498520.54220.54
414051-1405119.26219.26
513889-1388919.04019.04
616043-1604321.99321.99
10min125870-2587035.46434.813.3235.5034.843.32
226150-2615035.84835.88
324861-2486134.08134.11
424173-2417333.13833.17
525008-2500834.28234.31
626302-2630236.05636.09
15min132659-3265944.77143.812.1344.8643.902.14
232294-3229444.27044.37
331843-3184343.65243.74
430802-3080242.22542.31
531677-3167743.42443.51
632485-3248544.53244.63
20min136505-3650550.04350.041.6850.2150.211.68
237016-3701650.74350.91
336433-3643349.94450.11
435399-3539948.52748.68
536566-3656650.12650.29
637113-3711350.87651.05
30min142503-4250358.26558.151.1858.5258.401.18
242599-4259958.39758.65
342621-4262158.42758.67
441425-4142556.78757.03
542546-4254658.32458.57
642824-4282458.70558.96
45min148001-4800165.80265.981.3866.1566.321.37
249030-4903067.21367.56
347854-4785465.60165.95
447097-4709764.56364.90
548201-4820166.07666.42
648581-4858166.59766.95
60min151369-5136970.41970.370.3670.8870.830.37
251511-5151170.61471.08
351337-5133770.37570.83
451116-5111670.07270.51
551129-5112970.09070.54
651541-5154170.65571.12
90min155726-5572676.39276.070.6976.9776.640.69
255634-5563476.26676.85
355593-5559376.21076.78
454727-5472775.02275.58
555569-5556976.17776.75
655701-5570176.35876.94
120min157538-5753878.87679.770.9379.5880.470.93
258691-5869180.45781.17
358580-5858080.30481.00
457502-5750278.82779.51
558256-5825679.86080.56
658573-5857380.29581.00
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158700-5870080.46980.850.8081.3081.680.80
259394-5939481.42082.26
359058-5905880.96081.79
458196-5819679.77880.59
559085-5908580.99781.83
659435-5943581.47682.32
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%
110.146723666675672016717466919670410.36
210.146612966666663980.58
单位质量响应值RSD%判断
6611.546548.130.69数据可信
供试品溶液-2025072121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%
5min115486-1548621.11719.4814.2021.1219.4814.19
215421-1542121.02821.03
313832-1383218.86118.86
410352-1035214.11614.12
515487-1548721.11821.12
615121-1512120.61920.62
10min125815-2581535.20233.958.4635.2433.988.47
226019-2601935.48035.51
324356-2435633.21233.24
420840-2084028.41828.44
525977-2597735.42235.46
626355-2635535.93835.97
15min132550-3255044.38543.226.4344.4843.316.43
233058-3305845.07845.17
331031-3103142.31442.40
427829-2782937.94838.02
532948-3294844.92845.02
632778-3277844.69644.79
20min137220-3722050.75349.494.6550.9249.654.66
237527-3752751.17251.34
335683-3568348.65848.81
433180-3318045.24445.38
536548-3654849.83750.01
637594-3759451.26351.43
30min143285-4328559.02458.003.2459.2858.243.25
243583-4358359.43059.68
342098-4209857.40557.64
439960-3996054.49054.70
542771-4277158.32358.58
643489-4348959.30259.56
45min148451-4845166.06865.642.0166.4265.982.03
249130-4913066.99467.35
347210-4721064.37664.71
446800-4680063.81764.12
548148-4814865.65566.00
649104-4910466.95967.31
60min151809-5180970.64770.111.7771.1170.561.79
252158-5215871.12371.59
351037-5103769.59470.04
449753-4975367.84468.25
551652-5165270.43370.89
652087-5208771.02671.49
90min155889-5588976.21175.941.5076.7976.501.51
256784-5678477.43178.01
355170-5517075.23075.79
454360-5436074.12674.65
555860-5586076.17176.75
656065-5606576.45177.03
120min158487-5848779.75379.401.5780.4680.101.59
259571-5957181.23181.94
357519-5751978.43379.12
456930-5693077.63078.27
558341-5834179.55480.26
658532-5853279.81580.53
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159425-5942581.03280.411.4581.8781.241.46
260023-6002381.84882.70
358221-5822179.39180.20
457957-5795779.03179.80
558514-5851479.79080.63
659677-5967781.37682.22
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%
110.146628966912665136655466694665920.35
210.146616666395662800.25
单位质量响应值RSD%判断
6567.266536.490.34数据可信
供试品溶液-2025072221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%
5min115109-1510920.69018.3014.1220.6918.3014.13
213217-1321718.09918.10
314947-1494720.46820.47
414737-1473720.18120.18
511137-1113715.25115.25
611044-1104415.12415.12
10min125074-2507434.33632.417.2134.3732.447.21
223598-2359832.31532.35
324975-2497534.20134.23
424883-2488334.07534.11
522721-2272131.11431.14
620756-2075628.42328.45
15min132320-3232044.25942.004.9444.3542.094.95
230578-3057841.87441.96
331626-3162643.30943.40
431517-3151743.15943.25
529876-2987640.91240.99
628126-2812638.51638.59
20min136834-3683450.44148.493.8250.6148.653.83
235415-3541548.49748.65
336325-3632549.74449.91
436011-3601149.31449.48
534818-3481847.68047.83
633060-3306045.27245.41
30min142315-4231557.94656.832.6458.2057.062.66
242069-4206957.60957.84
341861-4186157.32557.57
441906-4190657.38657.63
541495-4149556.82357.05
639333-3933353.86354.07
45min147982-4798265.70764.912.0566.0565.242.07
247883-4788365.57165.90
347488-4748865.03065.37
447866-4786665.54865.89
547741-4774165.37765.70
645451-4545162.24162.54
60min151651-5165170.73169.681.8871.1970.121.89
251412-5141270.40470.84
351042-5104269.89770.35
450993-5099369.83070.28
551209-5120970.12670.55
649004-4900467.10667.51
90min155940-5594076.60475.801.7977.1876.351.80
256323-5632377.12977.69
355327-5532775.76576.33
455189-5518975.57676.14
555808-5580876.42476.97
653524-5352473.29673.81
120min158794-5879480.51379.581.8181.2180.261.82
258991-5899180.78281.47
358216-5821679.72180.41
457901-5790179.29079.98
558653-5865380.32080.99
656131-5613176.86677.51
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159239-5923981.12280.731.2881.9681.541.29
259735-5973581.80182.62
359028-5902880.83381.66
458650-5865080.31581.14
559438-5943881.39582.20
657615-5761578.89879.67
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%
110.146722267590675106748567664674940.25
210.146649166134663120.39
单位质量响应值RSD%判断
6656.216539.641.25数据可信
供试品溶液-2025072221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%
5min112756-1275617.34717.3215.4617.3517.3315.46
210748-1074814.61714.62
314034-1403419.08519.09
415167-1516720.62620.63
510088-1008813.71913.72
613641-1364118.55118.55
10min123207-2320731.56031.797.6931.5931.827.70
221386-2138629.08429.11
324281-2428133.02133.05
425975-2597535.32435.36
521345-2134529.02829.05
624063-2406332.72432.76
15min130067-3006740.88941.173.9240.9741.263.93
228847-2884739.23039.30
331131-3113142.33642.42
432093-3209343.64543.74
529338-2933839.89839.97
630178-3017841.04041.13
20min135693-3569348.54047.932.8648.6948.082.87
233926-3392646.13746.28
336008-3600848.96949.13
436568-3656849.73049.90
534509-3450946.93047.07
634745-3474547.25147.41
30min142639-4263957.98756.831.7058.2257.061.71
240771-4077155.44655.66
342414-4241457.68157.92
442075-4207557.22057.47
541530-4153056.47856.69
641317-4131756.18956.42
45min148180-4818065.52264.861.3765.8565.191.39
246984-4698463.89664.20
348024-4802465.31065.65
448459-4845965.90166.25
547657-4765764.81165.12
646858-4685863.72464.05
60min152063-5206370.80370.301.0271.2470.741.02
251539-5153970.09070.50
352226-5222671.02471.47
451426-5142669.93670.39
552075-5207570.81971.24
650848-5084869.15069.58
90min156167-5616776.38476.021.2876.9476.571.28
255447-5544775.40575.94
356750-5675077.17777.74
455837-5583775.93576.51
556408-5640876.71277.25
654771-5477174.48575.03
120min159155-5915580.44779.891.1281.1380.561.12
258729-5872979.86880.52
359137-5913780.42381.11
458931-5893180.14380.84
559069-5906980.33080.99
657443-5744378.11978.79
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159646-5964681.11580.860.9881.9381.680.97
259520-5952080.94481.73
359881-5988181.43582.26
459207-5920780.51881.35
560070-6007081.69282.49
658447-5844779.48580.29
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