Development studies of a new metronidazole certified reference material

Nogueira,Raquel; Rocha,Werickson F. C.; Silva,Thaís E.; Rego,Eliane C. P.; Moreira,Gabriela F.; Wollinger,Wagner; Rodrigues,Janaína M.

Development studies of a new metronidazole certified reference material

This paper presents the results of the studies carried out with the candidate certified reference material (CRM) of metronidazole, first CRM of this active pharmaceutical ingredient (API) available on the market and second Brazilian CRM of an API. The investigation includes the determination of organic impurities, inorganic impurities and volatiles, validation of the HPLC-DAD method, stability studies under transport and storage conditions, homogeneity testing, calculation of metronidazole content by mass balance, confirmation of the certified value by differential scanning calorimetry (DSC), and estimation of measurement uncertainties.

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Main Authors:	Nogueira,Raquel, Rocha,Werickson F. C., Silva,Thaís E., Rego,Eliane C. P., Moreira,Gabriela F., Wollinger,Wagner, Rodrigues,Janaína M.
Format:	Digital revista
Language:	English
Published:	Sociedade Brasileira de Química 2012
Online Access:	http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532012000300009
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spelling	oai:scielo:S0103-505320120003000092016-12-08Development studies of a new metronidazole certified reference materialNogueira,RaquelRocha,Werickson F. C.Silva,Thaís E.Rego,Eliane C. P.Moreira,Gabriela F.Wollinger,WagnerRodrigues,Janaína M. metronidazole certified reference materials active pharmaceutical ingredient (API) analytical quality control high performance liquid chromatography (HPLC) This paper presents the results of the studies carried out with the candidate certified reference material (CRM) of metronidazole, first CRM of this active pharmaceutical ingredient (API) available on the market and second Brazilian CRM of an API. The investigation includes the determination of organic impurities, inorganic impurities and volatiles, validation of the HPLC-DAD method, stability studies under transport and storage conditions, homogeneity testing, calculation of metronidazole content by mass balance, confirmation of the certified value by differential scanning calorimetry (DSC), and estimation of measurement uncertainties.info:eu-repo/semantics/openAccessSociedade Brasileira de QuímicaJournal of the Brazilian Chemical Society v.23 n.3 20122012-03-01info:eu-repo/semantics/articletext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532012000300009en10.1590/S0103-50532012000300009
institution	SCIELO
collection	OJS
country	Brasil
countrycode	BR
component	Revista
access	En linea
databasecode	rev-scielo-br
tag	revista
region	America del Sur
libraryname	SciELO
language	English
format	Digital
author	Nogueira,Raquel Rocha,Werickson F. C. Silva,Thaís E. Rego,Eliane C. P. Moreira,Gabriela F. Wollinger,Wagner Rodrigues,Janaína M.
spellingShingle	Nogueira,Raquel Rocha,Werickson F. C. Silva,Thaís E. Rego,Eliane C. P. Moreira,Gabriela F. Wollinger,Wagner Rodrigues,Janaína M. Development studies of a new metronidazole certified reference material
author_facet	Nogueira,Raquel Rocha,Werickson F. C. Silva,Thaís E. Rego,Eliane C. P. Moreira,Gabriela F. Wollinger,Wagner Rodrigues,Janaína M.
author_sort	Nogueira,Raquel
title	Development studies of a new metronidazole certified reference material
title_short	Development studies of a new metronidazole certified reference material
title_full	Development studies of a new metronidazole certified reference material
title_fullStr	Development studies of a new metronidazole certified reference material
title_full_unstemmed	Development studies of a new metronidazole certified reference material
title_sort	development studies of a new metronidazole certified reference material
description	This paper presents the results of the studies carried out with the candidate certified reference material (CRM) of metronidazole, first CRM of this active pharmaceutical ingredient (API) available on the market and second Brazilian CRM of an API. The investigation includes the determination of organic impurities, inorganic impurities and volatiles, validation of the HPLC-DAD method, stability studies under transport and storage conditions, homogeneity testing, calculation of metronidazole content by mass balance, confirmation of the certified value by differential scanning calorimetry (DSC), and estimation of measurement uncertainties.
publisher	Sociedade Brasileira de Química
publishDate	2012
url	http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532012000300009
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_version_	1756403470019067904

Development studies of a new metronidazole certified reference material

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