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%
110.166614766032665296619666152662110.29
210.246687967085669820.22
单位质量响应值RSD%判断
6516.836541.210.27数据可信
供试品溶液-bc1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%
5min127040-2704037.15836.203.1637.1636.203.16
226266-2626636.09536.09
326070-2607035.82535.83
426469-2646936.37436.37
524934-2493434.26434.26
627285-2728537.49537.49
10min140650-4065055.86155.631.5855.9255.681.58
240665-4066555.88255.94
339284-3928453.98454.04
441001-4100156.34356.40
540303-4030355.38455.44
640978-4097856.31256.37
15min147923-4792365.85565.442.2666.0165.592.26
247640-4764065.46765.62
345732-4573262.84562.99
448987-4898767.31867.47
548042-4804266.01966.17
647406-4740665.14565.30
20min152067-5206771.55070.862.4571.8171.122.44
252272-5227271.83272.09
349349-4934967.81568.07
452650-5265072.35172.62
552272-5227271.83272.09
650783-5078369.78670.05
30min156984-5698478.30777.132.5078.6977.512.49
256821-5682178.08378.47
353943-5394374.12874.50
457088-5708878.45078.84
557160-5716078.54978.93
654773-5477375.26975.65
45min159087-5908781.19781.942.2381.7182.452.23
260501-6050183.14083.65
357846-5784679.49279.98
460858-6085883.63184.15
560979-6097983.79784.31
658510-5851080.40480.91
60min160747-6074783.47884.422.0584.1385.072.04
262130-6213085.37986.03
360129-6012982.62983.25
462873-6287386.40087.06
562608-6260886.03586.69
660105-6010582.59683.24
90min163181-6318186.82387.191.6887.6187.981.68
263626-6362687.43488.23
362292-6229285.60186.36
464681-6468188.88489.69
564628-6462888.81189.60
662303-6230385.61686.39
120min165031-6503189.36588.911.5390.3089.841.53
264353-6435388.43389.37
363518-6351887.28688.19
465769-6576990.37991.33
565797-6579790.41891.36
663746-6374687.59988.52
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165319-6531989.76189.811.3790.8490.891.36
265154-6515489.53490.62
364617-6461788.79689.85
466398-6639891.24492.34
566382-6638291.22292.31
664248-6424888.28989.36
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%
110.166700266802665146688066702667800.28
210.246798568043680140.07
单位质量响应值RSD%判断
6572.836641.990.75数据可信
供试品溶液-bc2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%
5min123295-2329531.63334.245.0031.6334.244.99
225798-2579835.03235.03
324575-2457533.37133.37
425540-2554034.68134.68
525038-2503834.00034.00
627045-2704536.72536.72
10min139201-3920153.23253.823.1353.2853.873.13
240570-4057055.09155.15
337474-3747450.88750.94
439376-3937653.46953.53
540381-4038154.83454.89
640784-4078455.38155.44
15min146719-4671963.44163.193.1063.5863.343.09
247375-4737564.33264.48
344082-4408259.86060.00
445652-4565261.99262.14
547946-4794665.10765.25
647436-4743664.41464.57
20min150954-5095469.19268.363.0369.4468.613.03
251068-5106869.34669.60
347656-4765664.71364.95
449555-4955567.29267.54
551964-5196470.56370.82
650850-5085069.05069.31
30min156093-5609376.17074.372.7576.5374.732.75
255444-5544475.28975.66
352176-5217670.85171.20
453973-5397373.29173.65
556082-5608276.15576.53
654830-5483074.45574.83
45min159668-5966881.02479.212.2681.5179.702.26
259093-5909380.24480.74
355904-5590475.91376.38
458450-5845079.37079.86
558877-5887779.95080.45
658002-5800278.76279.26
60min162022-6202284.22181.822.3684.8582.452.35
260729-6072982.46583.10
357917-5791778.64779.24
460174-6017481.71282.33
561123-6112383.00083.63
659575-5957580.89881.53
90min163973-6397386.87084.922.4787.6485.682.46
262675-6267585.10885.88
360177-6017781.71682.44
462389-6238984.71985.47
564366-6436687.40488.18
661625-6162583.68284.45
120min165112-6511288.41787.041.6889.3387.941.68
264067-6406786.99887.91
362741-6274185.19786.06
463652-6365286.43487.33
565598-6559889.07790.00
663431-6343186.13487.04
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165084-6508488.37987.151.5989.4488.201.59
264325-6432587.34888.40
362676-6267685.10986.11
464102-6410287.04588.08
565428-6542888.84689.91
663467-6346786.18387.23
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