Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 2 de 2
Filtrar
Mais filtros










Base de dados
Intervalo de ano de publicação
1.
J Pharm Biomed Anal ; 48(1): 113-9, 2008 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-18584990

RESUMO

Residual solvents (RS) are volatile organic chemicals that are used or produced during the manufacturing process of drug substances or excipients. The European Pharmacopoeia (Ph. Eur.) limits the amount of RS in pharmaceuticals, considering the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines for RS. According to the Ph. Eur. general method, water insoluble samples may be analyzed using DMF as dilution solvent at high equilibration temperatures such as 105 degrees C. This could be problematic in the case of antibiotics, many of which are water insoluble and temperature sensitive. Moreover, antibiotics are complex in nature and beside RS, one can expect several other volatile impurity peaks in the chromatogram. In this study, the Ph. Eur. method for RS analysis was evaluated for selected groups of antibiotics. An alternative dilution medium was proposed (DMSO-water), which offers optimum sensitivity while working at lower equilibration temperatures such as 80 degrees C. The optimized method was investigated for precision, accuracy, linearity and detection limits.


Assuntos
Antibacterianos/análise , Contaminação de Medicamentos/prevenção & controle , Elétrons , Compostos Orgânicos/análise , Preparações Farmacêuticas/química , Solventes/análise , Acetamidas/análise , Dimetil Sulfóxido/análise , Dimetilformamida/análise , Europa (Continente) , Excipientes/química , Guias como Assunto , Humanos , Imidazóis/análise , Imidazolidinas/análise , Imidazolidinas/química , Espectrometria de Massas/métodos , Solubilidade , Volatilização
2.
J Pharm Biomed Anal ; 47(4-5): 834-40, 2008 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-18502600

RESUMO

An analytical method that allows simultaneous analysis of some (semi-)volatile drugs and additives in pharmaceuticals for topical use was developed using classical static headspace as sampling technique combined with gas chromatography (HS-GC). The capillary column used, RSL-200, showed good selectivity towards all the analytes in the samples investigated. Among the different dilution media investigated, dimethyl sulfoxide in combination with sodium chloride solution showed better sensitivity. Using the optimized headspace sample dilution medium, better sensitivities for all the analytes were achieved at low thermostatting temperature (85 degrees C). The optimized HS-GC method with flame ionization detection showed good repeatability, linearity and accuracy.


Assuntos
Cromatografia Gasosa/métodos , Pomadas/análise , Preparações Farmacêuticas/análise , Química Farmacêutica , Cromatografia Gasosa/instrumentação , Dimetil Sulfóxido/química , Contaminação de Medicamentos , Ionização de Chama , Concentração Osmolar , Padrões de Referência , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Cloreto de Sódio/química , Solventes/química , Temperatura , Fatores de Tempo , Volatilização , Água/química
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...