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10000
标示量(mg)1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%
110.386745368003668666764367273674480.63
210.406719567504673500.33
单位质量响应值RSD%判断
6497.886475.960.24数据可信
供试品溶液-2025072421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%
5min110564-1056414.61114.573.0214.6114.573.02
211060-1106015.29715.30
310375-1037514.35014.35
410318-1031814.27114.27
510186-1018614.08814.09
610718-1071814.82414.82
10min118499-1849925.58625.242.2825.6125.272.28
218620-1862025.75425.78
318119-1811925.06125.08
418145-1814525.09725.12
517531-1753124.24724.27
618589-1858925.71125.74
15min123047-2304731.87731.691.6031.9431.761.60
223117-2311731.97332.04
322822-2282231.56531.63
422905-2290531.68031.75
522263-2226330.79230.86
623338-2333832.27932.35
20min126433-2643336.56036.351.3636.6836.461.36
226457-2645736.59336.71
326104-2610436.10536.22
426315-2631536.39736.51
525669-2566935.50335.62
626691-2669136.91737.04
30min130701-3070142.46342.822.3542.6443.002.35
230780-3078042.57242.75
332267-3226744.62944.81
430746-3074642.52542.70
530096-3009641.62641.80
631156-3115643.09243.28
45min134422-3442247.60948.381.2547.8648.631.25
235019-3501948.43548.69
335031-3503148.45248.70
435294-3529448.81549.07
534548-3454847.78448.03
635569-3556949.19649.45
60min137880-3788052.39252.270.9552.7252.600.96
237680-3768052.11652.45
337626-3762652.04152.37
437999-3799952.55752.89
537255-3725551.52851.85
638305-3830552.98053.32
90min141877-4187757.92057.811.2758.3458.231.26
241432-4143257.30557.73
341862-4186257.90058.32
442275-4227558.47158.89
540975-4097556.67357.08
642381-4238158.61859.04
120min144291-4429161.25960.941.2261.7761.461.22
244048-4404860.92361.44
343967-4396760.81161.33
444123-4412361.02761.54
543154-4315459.68760.19
644798-4479861.96162.48
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145262-4526262.60262.080.8063.2262.700.81
244746-4474661.88962.51
345024-4502462.27362.89
444706-4470661.83362.45
544333-4433361.31761.92
645241-4524162.57363.20
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10000
标示量(mg)1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%
110.386708067037673336716567531672290.31
210.406742267327673740.10
单位质量响应值RSD%判断
6476.786478.270.02数据可信
供试品溶液-2025072421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%
5min19608-960813.30814.347.3413.3114.347.35
210073-1007313.95213.95
310730-1073014.86214.86
49431-943113.06313.06
511108-1110815.38615.39
611183-1118315.49015.49
10min116928-1692823.44724.784.0223.4724.804.01
217950-1795024.86324.89
318226-1822625.24525.27
417157-1715723.76423.79
518255-1825525.28525.31
618820-1882026.06826.09
15min122251-2225130.82031.291.6730.8831.351.67
222528-2252831.20431.27
323022-2302231.88831.95
422059-2205930.55430.62
522856-2285631.65831.73
622814-2281431.60031.67
20min125513-2551335.33836.081.6935.4536.191.69
226436-2643636.61736.73
326310-2631036.44236.56
425485-2548535.30035.41
526412-2641236.58436.70
626130-2613036.19336.31
30min129967-2996741.50842.081.2341.6842.261.23
230577-3057742.35342.53
330741-3074142.58042.76
429885-2988541.39441.57
530705-3070542.53042.71
630405-3040542.11442.30
45min134173-3417347.33348.041.0547.5748.291.05
234914-3491448.36048.61
335004-3500448.48448.74
434336-3433647.55947.80
535024-3502448.51248.76
634658-3465848.00548.26
60min137281-3728151.63851.980.6651.9652.310.66
237798-3779852.35452.68
337631-3763152.12352.46
437225-3722551.56151.88
537770-3777052.31652.65
637458-3745851.88452.22
90min140734-4073456.42157.140.8756.8357.560.87
241516-4151657.50457.92
341285-4128557.18457.60
441136-4113656.97857.38
541756-4175657.83758.26
641096-4109656.92357.34
120min143452-4345260.18660.420.8860.6960.930.87
243966-4396660.89861.41
344132-4413261.12861.64
443535-4353560.30160.80
543577-4357760.35960.88
643059-4305959.64260.16
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144373-4437361.46261.720.5662.0662.330.56
244778-4477862.02362.64
344530-4453061.67962.30
444747-4474761.98062.58
544763-4476362.00262.62
644175-4417561.18761.80
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10000
标示量(mg)1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%
110.386694667288671096711067280671470.22
210.406791167909679100.01
单位质量响应值RSD%判断
6468.886529.810.67数据可信
供试品溶液-2025072521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%
5min110456-1045614.43415.206.9514.4315.206.96
210947-1094715.11215.11
311558-1155815.95615.96
49977-997713.77313.77
511006-1100615.19415.19
612127-1212716.74116.74
10min118052-1805224.92125.233.7924.9425.253.79
218391-1839125.38925.41
319195-1919526.49926.53
417097-1709723.60223.63
518340-1834025.31825.34
618571-1857125.63725.67
15min123104-2310431.89531.612.7831.9631.672.79
223155-2315531.96532.03
323626-2362632.61632.69
421726-2172629.99330.05
522946-2294631.67731.74
622818-2281831.50031.57
20min126076-2607635.99836.381.6036.1236.501.60
226479-2647936.55436.67
327021-2702137.30237.43
425778-2577835.58635.70
526449-2644936.51336.63
626329-2632936.34736.47
30min130605-3060542.25042.291.6542.4342.471.65
230590-3059042.22942.41
331557-3155743.56443.75
430009-3000941.42741.60
530505-3050542.11242.29
630542-3054242.16342.35
45min134904-3490448.18548.051.3348.4348.301.33
234608-3460847.77648.03
335691-3569149.27149.53
434473-3447347.59047.83
534693-3469347.89348.14
634471-3447147.58747.84
60min137575-3757551.87251.951.0952.2052.281.09
237769-3776952.14052.47
338373-3837352.97453.32
437449-3744951.69852.02
537223-3722351.38651.72
637382-3738251.60651.94
90min141307-4130757.02457.120.8657.4457.540.86
241311-4131157.03057.45
342031-4203158.02358.45
441009-4100956.61357.02
541153-4115356.81157.23
641449-4144957.22057.64
120min144022-4402260.77260.480.8361.2860.990.83
243877-4387760.57261.09
344349-4434961.22361.75
443397-4339759.90960.41
543434-4343459.96060.47
643784-4378460.44360.96
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144517-4451761.45561.690.5262.0762.310.53
244715-4471561.72962.34
345116-4511662.28262.91
444540-4454061.48762.09
544512-4451261.44862.06
644733-4473361.75462.37
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10000
标示量(mg)1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%
110.386668366981668906701767108669360.25
210.406663666967668020.36
单位质量响应值RSD%判断
6448.556423.270.28数据可信
供试品溶液-2025072521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%
5min110516-1051614.66013.2910.7114.6613.2910.69
27996-799611.14711.15
310749-1074914.98514.98
49407-940713.11413.11
58920-892012.43512.44
69614-961413.40313.40
10min116963-1696323.64823.514.8823.6723.534.88
215761-1576121.97221.99
318139-1813925.28725.31
416892-1689223.54923.57
516223-1622322.61622.64
617193-1719323.96823.99
15min121802-2180230.39430.423.1630.4630.493.16
220910-2091029.15029.21
322965-2296532.01532.08
421636-2163630.16230.22
521505-2150529.98030.04
622127-2212730.84730.91
20min125502-2550235.55235.352.2935.6735.462.30
224677-2467734.40234.51
326145-2614536.44836.57
424764-2476434.52334.63
525247-2524735.19635.30
625814-2581435.98736.10
30min129849-2984941.61241.551.5441.7941.721.55
229394-2939440.97741.14
330372-3037242.34142.52
429284-2928440.82440.99
529617-2961741.28841.46
630306-3030642.24942.42
45min134135-3413547.58747.541.2947.8347.781.29
233860-3386047.20347.43
334646-3464648.29948.55
433916-3391647.28147.52
533493-3349346.69246.93
634546-3454648.16048.40
60min137370-3737052.09751.950.7952.4252.270.79
237109-3710951.73352.04
337297-3729751.99552.33
436766-3676651.25551.57
537529-3752952.31852.63
637535-3753552.32752.65
90min140987-4098757.13956.880.6357.5557.290.64
240506-4050656.46856.86
341082-4108257.27157.69
440922-4092257.04857.45
540470-4047056.41856.82
640840-4084056.93457.35
120min143631-4363160.82560.470.5761.3360.970.57
243455-4345560.57961.07
343639-4363960.83661.35
443237-4323760.27660.77
543024-4302459.97960.47
643263-4326360.31260.82
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144555-4455562.11361.850.7762.7262.450.77
244638-4463862.22962.82
344411-4441161.91262.53
444475-4447562.00162.60
543697-4369760.91761.51
644412-4441261.91462.52
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