ANALYSIS OF THE TEMPERATURE PROPOSED BY THE INTERNATIONAL CONFERENCE OF HARMONIZATION (ICH) FOR COLOMBIA IN THE LONG TERM STABILITY STUDIES OF DRUGS

The Mean Kinetic Temperature (MKT) concept is used to determine the storage and long term stability conditions of drug products in Colombia. It is considered that the value of 30°C fixed by I.C.H to our country should be reevaluated because of its climate conditions variability. Initially, to calcul...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Oscar A. FLOREZ A., Jhon J. ROJAS C., Cecilia GALLARDO C.
Formato:	article
Lenguaje:	EN
Publicado:	Universidad de Antioquia 2009
Materias:	Mean kinetic temperature stability studies in Colombia climatic zones storage conditions. Food processing and manufacture TP368-456 Pharmaceutical industry HD9665-9675
Acceso en línea:	https://doaj.org/article/72276c70aa2a488bb7b20384d3109d5a
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:72276c70aa2a488bb7b20384d3109d5a
record_format	dspace
spelling	oai:doaj.org-article:72276c70aa2a488bb7b20384d3109d5a2021-11-19T04:23:26ZANALYSIS OF THE TEMPERATURE PROPOSED BY THE INTERNATIONAL CONFERENCE OF HARMONIZATION (ICH) FOR COLOMBIA IN THE LONG TERM STABILITY STUDIES OF DRUGS0121-40042145-2660https://doaj.org/article/72276c70aa2a488bb7b20384d3109d5a2009-02-01T00:00:00Zhttps://revistas.udea.edu.co/index.php/vitae/article/view/486https://doaj.org/toc/0121-4004https://doaj.org/toc/2145-2660The Mean Kinetic Temperature (MKT) concept is used to determine the storage and long term stability conditions of drug products in Colombia. It is considered that the value of 30°C fixed by I.C.H to our country should be reevaluated because of its climate conditions variability. Initially, to calculate the MKT, equations proposed by different authors are taken and applied to temperature data of Medellín. Subsequently, the MKT values for other five representative cities of the several climatic conditions of the country (Barranquilla, Barrancabermeja, Bogotá, Neiva y Quibdo) are found by using the average, maximum and minimum temperature values reported monthly during the last 20 years in meteorological stations. Finally, the results are compared with those published in the ICH guideline. As a conclusion of this work, our country should fix its own storage conditions, because 30°C is insufficient to give a security margin that covers completely the extreme temperatures of all the national territory.Oscar A. FLOREZ A.Jhon J. ROJAS C.Cecilia GALLARDO C.Universidad de AntioquiaarticleMean kinetic temperaturestability studies in Colombiaclimatic zonesstorage conditions.Food processing and manufactureTP368-456Pharmaceutical industryHD9665-9675ENVitae, Vol 12, Iss 1 (2009)
institution	DOAJ
collection	DOAJ
language	EN
topic	Mean kinetic temperature stability studies in Colombia climatic zones storage conditions. Food processing and manufacture TP368-456 Pharmaceutical industry HD9665-9675
spellingShingle	Mean kinetic temperature stability studies in Colombia climatic zones storage conditions. Food processing and manufacture TP368-456 Pharmaceutical industry HD9665-9675 Oscar A. FLOREZ A. Jhon J. ROJAS C. Cecilia GALLARDO C. ANALYSIS OF THE TEMPERATURE PROPOSED BY THE INTERNATIONAL CONFERENCE OF HARMONIZATION (ICH) FOR COLOMBIA IN THE LONG TERM STABILITY STUDIES OF DRUGS
description	The Mean Kinetic Temperature (MKT) concept is used to determine the storage and long term stability conditions of drug products in Colombia. It is considered that the value of 30°C fixed by I.C.H to our country should be reevaluated because of its climate conditions variability. Initially, to calculate the MKT, equations proposed by different authors are taken and applied to temperature data of Medellín. Subsequently, the MKT values for other five representative cities of the several climatic conditions of the country (Barranquilla, Barrancabermeja, Bogotá, Neiva y Quibdo) are found by using the average, maximum and minimum temperature values reported monthly during the last 20 years in meteorological stations. Finally, the results are compared with those published in the ICH guideline. As a conclusion of this work, our country should fix its own storage conditions, because 30°C is insufficient to give a security margin that covers completely the extreme temperatures of all the national territory.
format	article
author	Oscar A. FLOREZ A. Jhon J. ROJAS C. Cecilia GALLARDO C.
author_facet	Oscar A. FLOREZ A. Jhon J. ROJAS C. Cecilia GALLARDO C.
author_sort	Oscar A. FLOREZ A.
title	ANALYSIS OF THE TEMPERATURE PROPOSED BY THE INTERNATIONAL CONFERENCE OF HARMONIZATION (ICH) FOR COLOMBIA IN THE LONG TERM STABILITY STUDIES OF DRUGS
title_short	ANALYSIS OF THE TEMPERATURE PROPOSED BY THE INTERNATIONAL CONFERENCE OF HARMONIZATION (ICH) FOR COLOMBIA IN THE LONG TERM STABILITY STUDIES OF DRUGS
title_full	ANALYSIS OF THE TEMPERATURE PROPOSED BY THE INTERNATIONAL CONFERENCE OF HARMONIZATION (ICH) FOR COLOMBIA IN THE LONG TERM STABILITY STUDIES OF DRUGS
title_fullStr	ANALYSIS OF THE TEMPERATURE PROPOSED BY THE INTERNATIONAL CONFERENCE OF HARMONIZATION (ICH) FOR COLOMBIA IN THE LONG TERM STABILITY STUDIES OF DRUGS
title_full_unstemmed	ANALYSIS OF THE TEMPERATURE PROPOSED BY THE INTERNATIONAL CONFERENCE OF HARMONIZATION (ICH) FOR COLOMBIA IN THE LONG TERM STABILITY STUDIES OF DRUGS
title_sort	analysis of the temperature proposed by the international conference of harmonization (ich) for colombia in the long term stability studies of drugs
publisher	Universidad de Antioquia
publishDate	2009
url	https://doaj.org/article/72276c70aa2a488bb7b20384d3109d5a
work_keys_str_mv	AT oscarafloreza analysisofthetemperatureproposedbytheinternationalconferenceofharmonizationichforcolombiainthelongtermstabilitystudiesofdrugs AT jhonjrojasc analysisofthetemperatureproposedbytheinternationalconferenceofharmonizationichforcolombiainthelongtermstabilitystudiesofdrugs AT ceciliagallardoc analysisofthetemperatureproposedbytheinternationalconferenceofharmonizationichforcolombiainthelongtermstabilitystudiesofdrugs
_version_	1718420428525928448

ANALYSIS OF THE TEMPERATURE PROPOSED BY THE INTERNATIONAL CONFERENCE OF HARMONIZATION (ICH) FOR COLOMBIA IN THE LONG TERM STABILITY STUDIES OF DRUGS

Ejemplares similares