METHOD OF FLUORIMETRIC DETERMINATION OF POTASSIUM CYANATE IN CARBAMYLATED DARBEPOIETIN ALPHA DRUG SUBSTANCE

Method of determination of potassium cyanate in carbamylated darbepoietin alpha drug substance was developed. The method is based on derivatization of cyanate by methyl ester of anthranilic acid followed by formation bicyclic derivative (1-H,3-H-quinazolinedione), which is able to fluorescence. Appl...

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Main Authors: A. D. Askretkov, M. A. Zhuchenko, N. V. Orlova
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2019-01-01
Series:Разработка и регистрация лекарственных средств
Subjects:
Online Access:https://www.pharmjournal.ru/jour/article/view/468
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spelling doaj-2bf47e4125c647768cc1511562f03ad62021-07-28T13:06:55ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492019-01-0103116122468METHOD OF FLUORIMETRIC DETERMINATION OF POTASSIUM CYANATE IN CARBAMYLATED DARBEPOIETIN ALPHA DRUG SUBSTANCEA. D. Askretkov0M. A. Zhuchenko1N. V. Orlova2Moscow Technological University (MITHT)Scientific Center of Russian Federation «Research Institute for Genetics and Selection of Industrial Microorganisms»Scientific Center of Russian Federation «Research Institute for Genetics and Selection of Industrial Microorganisms»Method of determination of potassium cyanate in carbamylated darbepoietin alpha drug substance was developed. The method is based on derivatization of cyanate by methyl ester of anthranilic acid followed by formation bicyclic derivative (1-H,3-H-quinazolinedione), which is able to fluorescence. Application of this method to determine potassium cyanate in protein drugs was investigated. Interference of excipients on this method was evaluated. The validation was performed: specificity, linearity, accuracy, precision, limit of quantitication.https://www.pharmjournal.ru/jour/article/view/468cyanatemethyl anthranilatederivatizationfluorimetrydarbepoietincarbamylated darbepoietin
collection DOAJ
language Russian
format Article
sources DOAJ
author A. D. Askretkov
M. A. Zhuchenko
N. V. Orlova
spellingShingle A. D. Askretkov
M. A. Zhuchenko
N. V. Orlova
METHOD OF FLUORIMETRIC DETERMINATION OF POTASSIUM CYANATE IN CARBAMYLATED DARBEPOIETIN ALPHA DRUG SUBSTANCE
Разработка и регистрация лекарственных средств
cyanate
methyl anthranilate
derivatization
fluorimetry
darbepoietin
carbamylated darbepoietin
author_facet A. D. Askretkov
M. A. Zhuchenko
N. V. Orlova
author_sort A. D. Askretkov
title METHOD OF FLUORIMETRIC DETERMINATION OF POTASSIUM CYANATE IN CARBAMYLATED DARBEPOIETIN ALPHA DRUG SUBSTANCE
title_short METHOD OF FLUORIMETRIC DETERMINATION OF POTASSIUM CYANATE IN CARBAMYLATED DARBEPOIETIN ALPHA DRUG SUBSTANCE
title_full METHOD OF FLUORIMETRIC DETERMINATION OF POTASSIUM CYANATE IN CARBAMYLATED DARBEPOIETIN ALPHA DRUG SUBSTANCE
title_fullStr METHOD OF FLUORIMETRIC DETERMINATION OF POTASSIUM CYANATE IN CARBAMYLATED DARBEPOIETIN ALPHA DRUG SUBSTANCE
title_full_unstemmed METHOD OF FLUORIMETRIC DETERMINATION OF POTASSIUM CYANATE IN CARBAMYLATED DARBEPOIETIN ALPHA DRUG SUBSTANCE
title_sort method of fluorimetric determination of potassium cyanate in carbamylated darbepoietin alpha drug substance
publisher LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
series Разработка и регистрация лекарственных средств
issn 2305-2066
2658-5049
publishDate 2019-01-01
description Method of determination of potassium cyanate in carbamylated darbepoietin alpha drug substance was developed. The method is based on derivatization of cyanate by methyl ester of anthranilic acid followed by formation bicyclic derivative (1-H,3-H-quinazolinedione), which is able to fluorescence. Application of this method to determine potassium cyanate in protein drugs was investigated. Interference of excipients on this method was evaluated. The validation was performed: specificity, linearity, accuracy, precision, limit of quantitication.
topic cyanate
methyl anthranilate
derivatization
fluorimetry
darbepoietin
carbamylated darbepoietin
url https://www.pharmjournal.ru/jour/article/view/468
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AT mazhuchenko methodoffluorimetricdeterminationofpotassiumcyanateincarbamylateddarbepoietinalphadrugsubstance
AT nvorlova methodoffluorimetricdeterminationofpotassiumcyanateincarbamylateddarbepoietinalphadrugsubstance
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