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%
110.316540265707659036588465504656800.35
210.256575265485656180.29
单位质量响应值RSD%判断
6370.516401.760.35数据可信
加速6月-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%
5min110826-1082615.21012.2624.0915.2112.2624.09
29334-933413.11413.11
38371-837111.76111.76
411132-1113215.64015.64
56606-66069.2819.28
66099-60998.5698.57
10min120490-2049028.78727.568.2828.8127.588.28
221468-2146830.16130.18
318382-1838225.82625.85
420885-2088529.34229.37
517225-1722524.20024.22
619243-1924327.03527.05
15min126613-2661337.39036.375.5837.4636.445.59
227623-2762338.80938.88
324534-2453434.46934.53
427014-2701437.95338.03
523967-2396733.67233.73
625577-2557735.93435.99
20min131904-3190444.82343.774.6944.9643.904.69
232504-3250445.66645.80
330048-3004842.21642.34
431306-3130643.98344.12
528802-2880240.46540.58
632369-3236945.47745.60
30min137410-3741052.55951.782.7252.7751.982.73
238160-3816053.61353.83
336692-3669251.55051.74
437282-3728252.37952.59
535281-3528149.56849.75
636312-3631251.01651.21
45min143076-4307660.51959.451.9060.8259.741.92
243449-4344961.04361.35
342144-4214459.21059.49
442195-4219559.28259.58
541382-4138258.13958.40
641656-4165658.52458.80
60min146817-4681765.77564.771.8266.1765.161.83
247074-4707466.13666.54
345910-4591064.50164.88
446517-4651765.35465.75
545071-4507163.32263.68
645221-4522163.53363.91
90min150979-5097971.62370.662.2472.1371.152.25
252213-5221373.35673.87
349990-4999070.23370.72
449923-4992370.13970.65
549119-4911969.00969.47
649536-4953669.59570.08
120min153548-5354875.23274.211.8475.8674.821.83
253767-5376775.54076.18
352162-5216273.28573.88
452386-5238673.59974.22
553643-5364375.36575.94
651420-5142072.24272.84
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154669-5466976.80776.441.8877.5677.181.89
256364-5636479.18879.95
354033-5403375.91376.64
453959-5395975.80976.56
553705-5370575.45276.16
653707-5370775.45576.18
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%
110.316586365928658046576165450657610.29
210.256571065854657820.16
单位质量响应值RSD%判断
6378.376417.760.44数据可信
加速6月-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%
5min16478-64789.08413.7623.049.0813.7623.05
211918-1191816.71316.71
311497-1149716.12316.12
411171-1117115.66515.67
57551-755110.58910.59
610255-1025514.38114.38
10min117647-1764724.74726.8211.5724.7626.8411.57
220854-2085429.24429.27
318575-1857526.04826.08
420967-2096729.40329.43
515673-1567321.97922.00
621040-2104029.50529.53
15min124474-2447434.32135.788.8434.3835.848.84
226895-2689537.71637.79
324655-2465534.57434.64
427625-2762538.73938.81
521895-2189530.70430.76
627539-2753938.61938.69
20min129714-2971441.66942.376.3441.7842.506.35
231516-3151644.19644.34
328787-2878740.36940.50
431768-3176844.54944.69
527349-2734938.35238.46
632133-3213345.06145.20
30min135700-3570050.06350.974.6650.2551.174.68
237087-3708752.00852.22
335184-3518449.34049.53
438149-3814953.49753.71
533926-3392647.57547.74
638041-3804153.34653.56
45min141733-4173358.52358.993.6358.7959.273.65
242224-4222459.21259.51
340857-4085757.29557.57
443704-4370461.28761.59
540025-4002556.12856.38
643852-4385261.49561.80
60min144966-4496663.05764.203.5063.4264.583.51
245834-4583464.27464.67
344542-4454262.46362.84
447775-4777566.99667.40
543978-4397861.67262.01
647612-4761266.76867.17
90min148984-4898468.69269.783.2469.1670.283.25
249967-4996770.07070.58
348313-4831367.75168.23
451665-5166572.45172.97
548014-4801467.33167.78
651636-5163672.41172.93
120min151873-5187372.74373.523.2973.3374.123.31
252395-5239573.47574.10
351174-5117471.76372.35
453948-5394875.65376.29
550282-5028270.51271.07
654890-5489076.97477.61
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154140-5414075.92275.931.9876.6376.662.01
254240-5424076.06276.81
353282-5328274.71975.43
454878-5487876.95777.72
552671-5267173.86274.54
655654-5565478.04578.81
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%
110.316560765248654516544565920655340.39
210.256575665801657780.05
单位质量响应值RSD%判断
6356.356417.370.68数据可信
加速6月-供试品溶液-2025072321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%
5min113513-1351318.98318.143.0518.9818.143.05
212952-1295218.19518.20
312759-1275917.92417.92
412734-1273417.88917.89
513148-1314818.47018.47
612365-1236517.37017.37
10min122057-2205730.98631.011.8131.0231.041.81
222779-2277932.00032.03
321641-2164130.40130.43
422171-2217131.14631.18
522026-2202630.94230.97
621761-2176130.57030.60
15min128567-2856740.13139.851.8540.2139.941.85
229259-2925941.10341.19
328192-2819239.60439.68
428336-2833639.80739.89
528173-2817339.57839.66
627688-2768838.89638.98
20min133086-3308646.47946.323.0146.6346.473.00
234903-3490349.03249.18
332294-3229445.36745.51
432610-3261045.81145.96
532286-3228645.35645.50
632661-3266145.88246.03
30min139009-3900954.80054.101.6955.0354.331.69
239402-3940255.35255.59
337934-3793453.29053.51
438252-3825253.73753.96
537730-3773053.00353.23
638753-3875354.44054.66
45min144301-4430162.23462.322.5462.5562.642.53
245399-4539963.77764.10
343621-4362161.27961.59
443442-4344261.02861.34
546055-4605564.69865.01
643362-4336260.91561.23
60min147855-4785567.22766.381.6467.6566.801.64
248553-4855368.20868.64
346760-4676065.68966.10
446903-4690365.89066.31
546669-4666965.56165.98
646769-4676965.70166.11
90min152281-5228173.44572.471.8173.9873.001.80
253005-5300574.46275.01
351728-5172872.66873.19
451054-5105471.72172.25
550551-5055171.01471.54
650919-5091971.53172.05
120min154507-5450776.57275.901.6077.2376.551.60
255566-5556678.06078.73
353524-5352475.19175.83
453632-5363275.34375.99
553636-5363675.34876.00
653295-5329574.86975.51
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156068-5606878.76577.861.2679.5578.641.27
256532-5653279.41780.22
354980-5498077.23678.01
454918-5491877.14977.92
555045-5504577.32878.10
654985-5498577.24378.01
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%
110.316569165881656406567365881657530.18
210.256600065308656540.75
单位质量响应值RSD%判断
6377.596405.270.31数据可信
中间条件6月-供试品溶液-2025072321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%
5min112700-1270017.82819.335.6217.8319.335.61
213729-1372919.27219.27
314310-1431020.08820.09
414632-1463220.54020.54
514240-1424019.99019.99
613007-1300718.25918.26
10min122889-2288932.13133.352.5432.1633.382.55
224021-2402133.72033.75
324344-2434434.17434.21
423910-2391033.56433.60
524249-2424934.04034.07
623140-2314032.48332.51
15min129363-2936341.21942.242.1941.3042.332.19
230341-3034142.59242.68
330725-3072543.13143.22
430024-3002442.14742.24
530810-3081043.25043.34
629287-2928741.11241.20
20min133837-3383747.50048.421.9847.6548.581.99
234518-3451848.45648.61
335452-3545249.76749.93
434416-3441648.31248.47
535062-3506249.21949.38
633688-3368847.29047.44
30min139427-3942755.34756.301.6455.5856.541.64
240453-4045356.78757.03
340896-4089657.40957.65
439994-3999456.14356.38
540586-4058656.97457.22
639272-3927255.12955.36
45min145218-4521863.47664.141.5463.8064.471.55
245875-4587564.39864.73
346677-4667765.52465.87
445575-4557563.97764.31
546125-4612564.74965.09
644677-4467762.71763.04
60min148827-4882768.54268.871.6368.9769.321.63
249600-4960069.62770.07
349797-4979769.90470.35
448765-4876568.45568.90
549681-4968169.74170.19
647712-4771266.97767.41
90min153025-5302574.43574.831.7374.9875.381.73
253363-5336374.91075.47
354408-5440876.37776.94
452714-5271473.99974.55
554293-5429376.21576.78
652035-5203573.04673.59
120min154999-5499977.20677.592.6777.8778.272.65
253104-5310474.54675.23
357338-5733880.49081.18
455209-5520977.50178.18
556413-5641379.19179.88
654587-5458776.62877.29
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156179-5617978.86379.741.5779.6680.541.57
257317-5731780.46081.27
357583-5758380.83481.66
456213-5621378.91079.72
557843-5784381.19982.02
655674-5567478.15478.94
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