The compatibility between packing material and ipratropium bromide aerosol / 药学学报
Acta Pharmaceutica Sinica
;
(12): 1035-1038, 2010.
Artigo
em Chinês
| WPRIM
| ID: wpr-353389
ABSTRACT
With the establishment of HPLC and LC-MS methods to determine the related substances and the content of active pharmaceutical ingredient (API) in ipratropium bromide aerosol products, several packing material-related impurities were identified, including antioxygen BHT and antioxygen 2246. Results showed that these leachable additives from the packing materials may present at a relative high level in the drug solution, and the low content of API in the drug products is usually due to the adsorption of the packing material as well as the leaking of contents. The current available assay methods for the control of ipratropium bromide aerosol products are often lack of specificity and unable to assure the drug quality effectively. To meet the increasing attention on the regulations of drug packing materials, our research would be a pilot study, indicating that the inappropriate packing materials could cause the migration and adsorption of the active ingredients, and the importance to have compatibility studies between packing materials and drugs.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Controle de Qualidade
/
Broncodilatadores
/
Hidroxitolueno Butilado
/
Química
/
Cromatografia Líquida de Alta Pressão
/
Ipratrópio
/
Espectrometria de Massas por Ionização e Dessorção a Laser Assistida por Matriz
/
Aerossóis
/
Incompatibilidade de Medicamentos
/
Embalagem de Medicamentos
Idioma:
Chinês
Revista:
Acta Pharmaceutica Sinica
Ano de publicação:
2010
Tipo de documento:
Artigo
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