Development studies of captopril certified reference material

作者：Nogueira Raquel^*; Pires do Rego Eliane Cristina; Barreto Sousa Marcus Vinicius; Wollinger Wagner; da Silva Thais Elias; Moreira Gabriela Fernandes; Barin Juliano Smanioto; Laporta Luciane Varini; Mesko Marcia Foster; Bittencourt Celso Figueiredo; Rodrigues Janaina Marques; da Cunha Valnei Smarcaro

来源：Brazilian Journal of Pharmaceutical Sciences, 2011, 47(2): 339-350.

DOI：10.1590/s1984-82502011000200015

• Captopril/qualitative analysis
• Medicines/Certified Reference Standards
• Medicines/analytical quality control
• High Pressure Liquid Chromatography (HPLC)/qualitative analysis
• Medicines/contamination

This paper describes the studies performed with the candidate Certified Reference Material (CRM) of captopril, the first CRM of an active pharmaceutical ingredient (API) in Brazil, including determination of impurities (organic, inorganic and volatiles), homogeneity testing, short- and long-term stability studies, calculation of captopril content using the mass balance approach, and estimation of the associated measurement uncertainty.

• 出版日期2011-6