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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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2019-01-01
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Online Access: | https://www.pharmjournal.ru/jour/article/view/468 |
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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 |
work_keys_str_mv |
AT adaskretkov methodoffluorimetricdeterminationofpotassiumcyanateincarbamylateddarbepoietinalphadrugsubstance AT mazhuchenko methodoffluorimetricdeterminationofpotassiumcyanateincarbamylateddarbepoietinalphadrugsubstance AT nvorlova methodoffluorimetricdeterminationofpotassiumcyanateincarbamylateddarbepoietinalphadrugsubstance |
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1721276833472708608 |