Isotopic ratios to detect infringements of patents or proprietary processes of pharmaceuticals: two case studies.
J Pharm Biomed Anal
; 48(1): 27-41, 2008 Sep 10.
Article
em En
| MEDLINE
| ID: mdl-18562148
ABSTRACT
Because of the increasing problem of drug counterfeiting and the potential danger related as well as the economic losses involved, the pharmaceutical industry and the regulatory instances are interested in the development of anti-counterfeiting and patent protection methodologies. In this paper, the evaluation of measured isotopic ratios by means of explorative chemometric techniques was performed to distinguish groups in two data sets containing samples of acetyl salicylic acid and ibuprofen, respectively. The samples in the data sets originated from different countries and manufacturers. For both compounds a clear distinction of groups of samples could be obtained. These groups could be explained based on the origin of the samples, both geographically as well as based on the manufacturer. Hypotheses were formulated concerning the synthetic pathways of the molecules and they were linked to the groups obtained with the chemometric tools.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Isótopos de Carbono
/
Preparações Farmacêuticas
/
Ibuprofeno
/
Analgésicos não Narcóticos
/
Ácido Salicílico
/
Indústria Farmacêutica
Idioma:
En
Revista:
J Pharm Biomed Anal
Ano de publicação:
2008
Tipo de documento:
Article