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%
19.996495364886645406483164844648110.25
210.066431964079641990.27
单位质量响应值RSD%判断
6487.596381.611.17数据可信
影响因素30天-供试品溶液-2025072321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126155-2615536.47235.307.0036.4735.307.00
228127-2812739.22239.22
325064-2506434.95034.95
422805-2280531.80031.80
525237-2523735.19235.19
624483-2448334.14034.14
10min140840-4084056.94957.532.4157.0157.582.41
242995-4299559.95460.02
340171-4017156.01656.07
441755-4175558.22558.28
540873-4087356.99557.05
640890-4089057.01957.08
15min148455-4845567.56867.671.3767.7267.831.37
248758-4875867.99068.16
348870-4887068.14768.30
449386-4938668.86669.02
547418-4741866.12266.28
648300-4830067.35267.50
20min152342-5234272.98872.811.9173.2673.081.91
253599-5359974.74175.02
352267-5226772.88473.15
452900-5290073.76674.03
551001-5100171.11871.38
651189-5118971.38071.64
30min156569-5656978.88279.380.6279.2779.770.62
257053-5705379.55779.96
357306-5730679.91080.30
457257-5725779.84280.23
556472-5647278.74779.13
656892-5689279.33379.72
45min158981-5898182.24683.521.1182.7784.041.10
260424-6042484.25884.79
359928-5992883.56684.09
460723-6072384.67585.20
559293-5929382.68183.19
660012-6001283.68484.20
60min159956-5995683.60585.141.3684.2685.801.35
261627-6162785.93686.61
360838-6083884.83585.49
461857-6185786.25686.92
560256-6025684.02484.68
661789-6178986.16186.82
90min161822-6182286.20887.141.7987.0187.951.77
263009-6300987.86388.68
361314-6131485.49986.30
464433-6443389.84890.65
561924-6192486.35087.14
662460-6246087.09787.90
120min163418-6341888.43387.522.3089.3788.462.28
262454-6245487.08988.05
360596-6059684.49885.44
464805-6480590.36791.32
563355-6335588.34589.28
661946-6194686.38087.32
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163799-6379988.96489.580.8090.0590.680.80
264813-6481390.37891.49
364278-6427889.63290.72
464774-6477490.32491.43
564256-6425689.60290.68
663544-6354488.60989.70
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%
19.996564065757657146558565848657090.16
210.066590265494656980.44
单位质量响应值RSD%判断
6577.486530.620.51数据可信
影响因素30天-供试品溶液-2025072321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127008-2700836.97335.2818.4336.9735.2818.43
230154-3015441.28041.28
323143-2314331.68231.68
428974-2897439.66439.66
527966-2796638.28438.28
617403-1740323.82423.82
10min142032-4203257.54057.249.2157.6057.309.22
245719-4571962.58762.66
341656-4165657.02557.08
443776-4377659.92859.99
543185-4318559.11859.18
634531-3453147.27147.31
15min149642-4964267.95867.615.6368.1267.765.65
252402-5240271.73671.91
349459-4945967.70767.86
450549-5054969.19969.37
550129-5012968.62468.79
644138-4413860.42360.54
20min154267-5426774.28973.443.1674.5673.703.18
255010-5501075.30675.60
354125-5412574.09574.36
453820-5382073.67773.96
554353-5435374.40774.68
650285-5028568.83869.06
30min157521-5752178.74478.782.3779.1479.172.39
259241-5924181.09881.52
357784-5778479.10479.49
457962-5796279.34879.75
557709-5770979.00179.40
655075-5507575.39575.73
45min160118-6011882.29982.342.0382.8282.862.05
260796-6079683.22783.78
360183-6018382.38882.90
461061-6106183.59084.13
560935-6093583.41783.95
657796-5779679.12079.58
60min161808-6180884.61383.211.7485.2883.871.76
261671-6167184.42585.12
360822-6082283.26383.92
460490-6049082.80883.48
561028-6102883.54584.22
658896-5889680.62681.22
90min163016-6301686.26684.801.9587.0785.601.97
262206-6220685.15785.99
361985-6198584.85585.65
462247-6224785.21486.03
562613-6261385.71586.53
659595-5959581.58382.31
120min162538-6253885.61284.971.9286.5685.911.93
262851-6285186.04087.02
362453-6245385.49686.43
461678-6167884.43585.39
563063-6306386.33187.28
659852-5985281.93582.80
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163894-6389487.46887.630.9688.5688.711.00
264718-6471888.59689.71
364035-6403587.66188.74
464043-6404387.67288.77
564453-6445388.23389.33
662926-6292686.14387.14
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%
19.996363363804636346387063546636970.22
210.066501065042650260.04
单位质量响应值RSD%判断
6376.086463.820.97数据可信
影响因素30天-供试品溶液-2025072321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130357-3035742.42740.626.1942.4340.626.20
228787-2878740.23340.23
329028-2902840.57040.57
425673-2567335.88135.88
530236-3023642.25842.26
630307-3030742.35742.36
10min145387-4538763.43361.372.6663.5061.442.66
243442-4344260.71560.78
343952-4395261.42761.49
441926-4192658.59658.66
544396-4439662.04862.12
644353-4435361.98862.06
15min151741-5174172.31371.071.6872.4971.241.68
250700-5070070.85871.03
350794-5079470.99071.16
449352-4935268.97469.13
551584-5158472.09472.27
650943-5094371.19871.37
20min155433-5543377.47376.061.2977.7776.341.29
253798-5379875.18875.47
354387-5438776.01176.30
453494-5349474.76375.04
554772-5477276.54976.84
654636-5463676.35976.65
30min158775-5877582.14481.391.0982.5781.811.09
258327-5832781.51881.93
357936-5793680.97181.39
457244-5724480.00480.40
559014-5901482.47882.90
658131-5813181.24481.66
45min160719-6071984.86185.000.8585.4285.550.86
260769-6076984.93185.48
360889-6088985.09885.65
459940-5994083.77284.30
561476-6147685.91986.48
661125-6112585.42885.98
60min162331-6233187.11486.110.8687.8286.800.87
261598-6159886.08986.78
361549-6154986.02186.71
460741-6074184.89285.56
561943-6194386.57287.27
661500-6150085.95286.65
90min163170-6317088.28687.481.2889.1488.321.27
262269-6226987.02787.86
361764-6176486.32187.16
462104-6210486.79787.61
563915-6391589.32890.17
662341-6234187.12887.97
120min163210-6321088.34288.071.0589.3489.061.04
263489-6348988.73289.71
361932-6193286.55687.54
462807-6280787.77988.74
563827-6382789.20590.20
662844-6284487.83188.82
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164591-6459190.27290.270.6491.4291.400.63
265009-6500990.85791.98
364905-6490590.71191.83
464502-6450290.14891.25
564674-6467490.38891.53
663848-6384889.23490.37
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