培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.024296543059430554307742996430300.12
210.024315943036430980.21
单位质量响应值RSD%判断
4294.414301.200.12数据可信
供试品溶液-2022081302-1批-10mg/5mg规格-培哚普利-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min149860-4986098.98298.801.1098.9898.801.10
250605-50605100.461100.46
349948-4994899.15799.16
449730-4973098.72498.72
548935-4893597.14697.15
649543-4954398.35398.35
10min150063-5006399.38599.040.84100.48100.130.84
250215-5021599.687100.80
349810-4981098.88399.98
450114-5011499.486100.58
549085-4908597.44498.52
650040-5004099.339100.43
15min149551-4955198.36998.070.82100.57100.260.81
249832-4983298.927101.15
349628-4962898.522100.72
448900-4890097.07699.28
548890-4889097.05699.22
649591-4959198.448100.64
20min149109-4910997.49196.981.14100.79100.271.12
249526-4952698.319101.64
348210-4821095.70799.00
449058-4905897.390100.67
548134-4813495.55698.80
649081-4908197.436100.73
30min148151-4815195.58995.590.5699.9799.960.57
248411-4841196.106100.52
347972-4797295.23499.59
448169-4816995.62599.99
547748-4774894.78999.09
648458-4845896.199100.57
45min148829-4882996.93595.171.43102.38100.591.38
248486-4848696.254101.74
348153-4815395.593101.01
447632-4763294.55999.98
546961-4696193.22798.58
647568-4756894.43299.87
极限147170-4717093.64293.800.87100.16100.290.86
247889-4788995.069101.62
347366-4736694.031100.51
447068-4706893.43999.92
546652-4665292.61499.00
647359-4735994.017100.51
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.878200482180820968213381964820750.11
213.908213482339822360.18
单位质量响应值RSD%判断
5917.455916.260.02数据可信
供试品溶液-2022081302-1批-10mg/5mg规格-氨氯地平-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min134452-3445237.74637.439.2737.7537.439.27
235782-3578239.20339.20
335613-3561339.01839.02
435586-3558638.98838.99
535763-3576339.18239.18
627781-2778130.43730.44
10min167932-6793274.42673.123.0674.8573.543.08
265053-6505371.27271.71
368282-6828274.81075.24
468527-6852775.07875.51
567196-6719673.62074.06
663454-6345469.52069.86
15min172883-7288379.85180.213.0581.1081.443.04
269539-6953976.18777.41
374996-7499682.16683.43
474529-7452981.65482.92
575385-7538582.59283.85
671957-7195778.83679.95
20min173841-7384180.90082.713.0783.0384.833.05
271920-7192078.79680.87
376534-7653483.85186.03
478242-7824285.72287.90
577120-7712084.49386.66
675287-7528782.48584.47
30min175486-7548682.70384.383.7085.7487.423.64
272089-7208978.98181.93
378366-7836685.85888.97
479574-7957487.18190.31
579333-7933386.91790.03
677281-7728184.66987.57
45min178255-7825585.73685.713.1189.6989.683.10
273867-7386780.92984.76
380141-8014187.80391.87
480166-8016687.83091.93
579695-7969587.31491.39
677239-7723984.62388.47
极限179955-7995587.59989.671.6492.5094.601.68
280472-8047288.16592.89
382945-8294590.87595.91
482863-8286390.78595.86
582981-8298190.91495.96
681838-8183889.66294.45
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.024300643018429594287143075429860.18
210.024288642924429050.07
单位质量响应值RSD%判断
4290.024281.940.14数据可信
供试品溶液-2022081302-1批-10mg/5mg规格-培哚普利-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min150569-50569100.66799.550.67100.6799.550.68
249920-4992099.37599.37
349697-4969798.93198.93
449726-4972698.98998.99
549906-4990699.34799.35
650234-50234100.000100.00
10min150150-5015099.83399.260.88100.95100.360.88
249562-4956298.66299.77
349411-4941198.36199.46
449937-4993799.409100.51
549555-4955598.64899.75
650555-50555100.639101.75
15min149395-4939598.33098.580.78100.56100.780.77
249148-4914897.838100.04
349133-4913397.808100.00
449651-4965198.839101.04
549627-4962798.791100.99
650156-5015699.845102.07
20min149507-4950798.55397.270.87101.87100.580.86
248471-4847196.49099.78
348374-4837496.29799.58
448809-4880997.163100.47
548878-4887897.300100.60
649148-4914897.838101.18
30min148870-4887097.28496.240.60101.70100.630.59
248309-4830996.168100.53
348330-4833096.210100.56
448154-4815495.859100.24
548024-4802495.60099.98
648390-4839096.329100.75
45min148538-4853896.62495.360.91102.12100.820.89
247360-4736094.27999.71
347706-4770694.967100.39
448000-4800095.553101.00
547591-4759194.738100.18
648226-4822696.002101.50
极限147830-4783095.21494.091.04101.78100.601.00
246522-4652292.61099.09
347394-4739494.346100.82
447449-4744994.456100.96
546835-4683593.23399.73
647565-4756594.687101.25
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.878217182018819298208281907820210.14
213.908190681967819360.06
单位质量响应值RSD%判断
5913.555894.680.23数据可信
供试品溶液-2022081302-1批-10mg/5mg规格-氨氯地平-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min133348-3334836.61538.805.3336.6238.805.33
234362-3436237.72837.73
336852-3685240.46240.46
437688-3768841.38041.38
536389-3638939.95439.95
633366-3336636.63536.63
10min162902-6290269.06473.704.2969.4774.134.29
264592-6459270.92071.34
370665-7066577.58878.04
468923-6892375.67576.14
567434-6743474.04074.48
668221-6822174.90475.31
15min168250-6825074.93681.145.5176.1182.395.49
269237-6923776.02077.23
377819-7781985.44386.75
476221-7622183.68884.99
575746-7574683.16784.43
676142-7614283.60184.84
20min171667-7166778.68883.835.1680.6985.985.15
271152-7115278.12380.17
380332-8033288.20290.46
477714-7771485.32787.56
578009-7800985.65187.84
679207-7920786.96789.13
30min173606-7360680.81785.884.7383.7088.974.73
273579-7357980.78783.71
382158-8215890.20793.45
479723-7972387.53390.71
579599-7959987.39790.54
680657-8065788.55991.69
45min175773-7577383.19687.295.4886.9891.325.43
272801-7280179.93383.75
383880-8388092.09896.34
481152-8115289.10293.25
580210-8021088.06892.18
683173-8317391.32195.44
极限179820-7982087.64090.113.3992.3495.113.44
278426-7842686.10990.81
385575-8557593.95999.23
482928-8292891.05296.19
581096-8109689.04194.13
684560-8456092.84497.98
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