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%
110.086527466339655856561265274656170.67
210.056609866675663860.62
单位质量响应值RSD%判断
6509.626605.571.04数据可信
供试品溶液-25041501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%
5min113262-1326218.14617.9710.2718.1517.9810.27
214196-1419619.42419.42
313482-1348218.44718.45
410457-1045714.30814.31
513733-1373318.79018.79
613690-1369018.73218.73
10min122984-2298431.44831.464.8231.4831.494.83
223865-2386532.65432.69
323636-2363632.34032.37
420816-2081628.48228.51
523271-2327131.84131.87
623380-2338031.99032.02
15min129173-2917339.91739.623.2440.0039.703.25
229638-2963840.55340.64
329404-2940440.23340.32
427091-2709137.06837.14
529048-2904839.74639.83
629387-2938740.20940.29
20min132866-3286644.97045.431.9545.1245.571.96
233953-3395346.45746.61
333657-3365746.05246.20
432120-3212043.94944.08
533199-3319945.42545.58
633401-3340145.70245.85
30min138501-3850152.68053.131.1152.9053.361.12
239178-3917853.60653.84
339473-3947354.01054.24
438326-3832652.44052.65
538662-3866252.90053.13
638854-3885453.16353.39
45min143752-4375259.86560.310.6960.1860.620.69
244409-4440960.76461.08
344282-4428260.59060.91
443666-4366659.74760.04
544230-4423060.51960.83
644123-4412360.37260.69
60min147424-4742464.88965.000.7065.3065.410.70
247725-4772565.30165.72
348071-4807165.77466.19
447223-4722364.61465.01
547303-4730364.72365.14
647277-4727764.68865.10
90min151644-5164470.66370.820.3071.1871.340.31
251898-5189871.01171.54
351892-5189271.00271.53
451599-5159970.60171.10
551900-5190071.01371.54
651620-5162070.63071.15
120min155035-5503575.30374.670.5975.9475.310.59
254543-5454374.63075.28
354674-5467474.80975.46
454210-5421074.17474.79
554745-5474574.90675.55
654225-5422574.19574.84
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155760-5576076.29575.990.5777.0676.760.57
255649-5564976.14376.92
355997-5599776.61977.39
455219-5521975.55576.30
555304-5530475.67176.44
655296-5529675.66076.43
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%
110.086557765590655596541565494655270.12
210.056649666798666470.33
单位质量响应值RSD%判断
6500.696631.541.41数据可信
供试品溶液-25041801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%
5min110692-1069214.61117.7111.2414.6117.7111.24
211653-1165315.92515.92
314155-1415519.34419.34
413288-1328818.15918.16
513738-1373818.77418.77
614226-1422619.44119.44
10min121212-2121228.98731.144.8929.0131.174.90
221503-2150329.38529.41
323656-2365632.32732.36
423458-2345832.05732.09
523493-2349332.10532.14
623388-2338831.96131.99
15min128188-2818838.52139.541.7338.5939.621.74
228559-2855939.02839.10
329115-2911539.78739.87
429495-2949540.30740.39
529376-2937640.14440.23
628853-2885339.42939.52
20min132800-3280044.82345.291.0544.9645.441.06
232735-3273544.73444.87
333320-3332045.53445.69
433296-3329645.50145.65
533646-3364645.97946.13
633061-3306145.18045.33
30min138513-3851352.63052.630.8752.8452.850.87
238303-3830352.34352.56
338522-3852252.64352.87
439124-3912453.46553.69
538149-3814952.13352.36
638448-3844852.54152.77
45min144206-4420660.41059.970.8860.7160.280.87
243339-4333959.22559.53
343875-4387559.95860.27
444179-4417960.37360.69
544192-4419260.39160.71
643498-4349859.44359.76
60min147385-4738564.75464.600.6965.1565.020.69
246883-4688364.06864.47
347044-4704464.28864.70
447535-4753564.95965.38
547722-4772265.21565.63
647086-4708664.34664.76
90min151462-5146270.32670.000.7570.8370.520.75
251072-5107269.79370.30
350946-5094669.62170.14
451612-5161270.53171.06
551588-5158870.49871.02
650682-5068269.26069.78
120min154618-5461874.63973.850.7475.2674.490.73
254198-5419874.06574.69
353617-5361773.27173.91
454261-5426174.15174.79
553979-5397973.76674.41
653585-5358573.22773.86
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155566-5556675.93475.340.5776.6876.100.56
255195-5519575.42776.17
354773-5477374.85175.61
455240-5524075.48976.25
555241-5524175.49076.26
654768-5476874.84475.60
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%
110.086591865739656686565065914657780.20
210.056559565507655510.10
单位质量响应值RSD%判断
6525.606522.490.04数据可信
供试品溶液-25041802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%
5min110763-1076314.80217.338.6814.8017.338.68
212961-1296117.82417.82
314028-1402819.29219.29
412090-1209016.62716.63
512930-1293017.78217.78
612857-1285717.68117.68
10min120868-2086828.69830.423.9228.7230.453.94
222249-2224930.59830.63
323460-2346032.26332.30
421570-2157029.66429.69
522187-2218730.51230.54
622386-2238630.78630.82
15min127436-2743637.73138.472.0037.8038.542.01
227909-2790938.38138.46
329022-2902239.91240.00
427753-2775338.16738.24
527648-2764838.02338.10
628061-2806138.59138.67
20min131551-3155143.39044.311.6443.5344.461.64
232150-3215044.21444.36
333084-3308445.49845.65
432352-3235244.49244.63
532357-3235744.49944.64
631838-3183843.78543.93
30min137452-3745251.50551.840.7751.7152.060.77
237623-3762351.74151.96
338200-3820052.53452.76
437666-3766651.80052.01
537419-3741951.46051.68
637815-3781552.00552.22
45min142965-4296559.08759.110.4559.3859.420.46
242921-4292159.02759.33
343252-4325259.48259.80
443034-4303459.18259.48
542667-4266758.67758.98
643070-4307059.23159.54
60min146828-4682864.40064.170.5464.7964.580.54
246490-4649063.93564.34
346965-4696564.58865.00
446513-4651363.96664.37
546343-4634363.73364.13
646847-4684764.42664.83
90min151157-5115770.35370.190.6570.8570.700.65
250823-5082369.89470.40
351608-5160870.97371.50
450988-5098870.12170.63
550660-5066069.66970.18
650984-5098470.11570.63
120min153107-5310773.03573.650.9873.6574.280.98
252912-5291272.76773.39
354073-5407374.36375.00
454138-5413874.45375.08
553291-5329173.28873.91
653826-5382674.02374.65
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154992-5499275.62775.350.7176.3776.100.71
254661-5466175.17275.92
355363-5536376.13776.90
454859-5485975.44476.19
554215-5421574.55875.30
654669-5466975.18375.93
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