Development studies of captopril certified reference material

Brazilian Journal of Pharmaceutical Sciences

Volumn 47, Issue 2, 2011, Pages 339-350

  Nogueira, Raquel ^a   do Rego, Eliane Cristina Pires ^a   Sousa, Marcus Vinicius Barreto ^a   Wollinger, Wagner ^a   da Silva, Thaís Elias ^a   Moreira, Gabriela Fernandes ^a   Barin, Juliano Smanioto ^a   Laporta, Luciane Varini ^a   Mesko, Márcia Foster ^a   Bittencourt, Celso Figueiredo ^a   Rodrigues, Janaína Marques ^a   da Cunha, Valnei Smarçaro ^a  

^a INSTITUTO NACIONAL DE METROLOGIA   (Brazil)

Author keywords

Captopril qualitative analysis; High pressure liquid chromatography (HPLC) qualitative analysis; Medicines contamination; Medicines analytical quality control; Medicines certified reference standards

Indexed keywords

CAPTOPRIL; INORGANIC COMPOUND; ORGANIC COMPOUND; VOLATILE AGENT;

ANALYTICAL PARAMETERS; ARTICLE; BRAZIL; CALCULATION; CERTIFIED REFERENCE MATERIAL; CONTROLLED STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG CONTAMINATION; DRUG DETERMINATION; DRUG IMPURITY; DRUG QUALITY; DRUG STABILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MASS BALANCE; MASS SPECTROMETRY; QUALITY CONTROL; QUANTITATIVE ANALYSIS; UNCERTAINTY;

EID: 84860389265     PISSN: 19848250     EISSN: 21759790     Source Type: Journal    
DOI: 10.1590/S1984-82502011000200015     Document Type: Article

References (24)

1. AMERICAN SOCIETY FOR TESTING AND MATERIALS INTERNATIONAL. ASTM Standards E 928-08. Standard test method for purity by Differential Scanning Calorimetry. Pennsylvania: ASTM International, 2008, 7 p.
2. ASSOCIAÇÃO BRASILEIRA DE NORMAS TÉCNICAS. ABNT NBR ISO/IEC 17025:2005. Requisitos gerais para competência de laboratórios de ensaio e calibração. Rio de Janeiro: ABNT, 2005. 31 p.
3. ASSOCIAÇÃO BRASILEIRA DE NORMAS TÉCNICAS/ INSTITUTONACIONAL DEMETROLOGIA, NORMALIZAÇÃO E QUALIDADE INDUSTRIAL. Guia para a expressão da incerteza de medição. 3.ed. (revisada). Rio de Janeiro: ABNT/Inmetro, 2003. 120 p.
4. DUEWER, D.L.; PARRIS, R.M.; WHITE, E.V.; MAY, W.E.; ELBAUM, H. An approach to the metrologically sound traceable assessment of the chemical purity of organic reference materials. National Institute of Standards and Technology special publication 1012. Gaithersburg: National Institute of Standards and Technology (NIST), 2004. 53 p.
5. EURACHEM/COOPERATION ON INTERNATIONAL TRACEABILITY IN ANALYTICAL CHEMISTRY. EURACHEM/CITAC Guide CG 4. Quantifying uncertainty in analytical measurement. 2.ed. London, 2000. 120 p. Available at: http://www.eurachem.org/guides/pdf/ QUAM2000-1.pdf. Accessed on: 10 jun. 2010.
6. FARMACOPEIA BRASILEIRA. 4.ed. São Paulo: Atheneu, 2002. pt.2. p.181.
7. GOROG, S. The sacred cow: the questionable role of assay methods in characterizing the quality of bulk pharmaceuticals. J. Pharm. Biomed. Anal., v.36, n.5, p.931-937, 2005.
8. HOFER, J.D.; OLSEN, B. A.; RICKARD, E. C. Is HPLC assay for drug substance a useful quality control attribute? J. Pharm. Biomed. Anal., v.44, n.4, p.906-913, 2007.
9. INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE (ICH). ICH harmonised tripartite guideline. Validation of Analytical Procedures: text and methodology. Q2(R1). Current Step 4 version. Parent Guideline dated 27 October 1994. Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005. Available at: http://www.ich.org/LOB/media/MEDIA417.pdf. Accessed on: 01 jul. 2009.
10. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. ISO guide 30. Terms and definitions used in connection with reference materials. Geneve, 1992. 8 p.
11. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. ISO guide 30 / Amd. 1. Terms and definitions used in connection with reference materials. Amendment 1. Revision of definitions for reference material and certified reference material. Geneve, 2008. 2 p.
12. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. ISO Guide 34. General requirements for the competence of reference material producers. Geneve, 2009. 34 p.
13. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. ISO Guide 35. Reference materials - general and statistical principles for certification. Geneve, 2006. 64 p.
14. JOINT COMMITTEE FOR GUIDES IN METROLOGY (JCGM). International vocabulary of metrology: basic and general concepts and associated terms (VIM). JCGM 200:2008. 3.ed. Sèvres (France): BIPM, 2008. 90 p. Available at: http://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2008.pdf. Accessed on: 26 jun. 2010.
15. KUSELMAN, I.; WEISMAN, A.; WEGSCHEIDER, W. Traceability without uncertainty: current situation in the pharmaceutical industry. Accred. Qual. Assur., v.8, n.11, p.530-531, 2003.
16. LE GOFF, T.; WOOD, S. Improvement of the traceability of reference materials certified for purity: evaluation of a semi-preparative high-performance liquid chromatography approach. Anal. Bioanal. Chem., v.394, n.8, p.2183-2192, 2009.
17. LABORATORY OF THE GOVERNMENT CHEMIST (LGC) STANDARDS. Pharmaceutical reference substances and impurities 2010 / 2011. Teddington, 2010. 421 p. Available at: http://lgcstandards.com/media/559600807.pdf. Accessed on: 29 sep. 2010.
18. MATHKAR, S.; KUMAR, S.; BYSTOL, A.; OLAWOORE, K.; MIN, D.; MARKOVICH, R.; RUSTUM, A. The use of differential scanning calorimetry for the purity verification of pharmaceutical reference standards. J. Pharm. Biomed. Anal., v.49, n.3, p.627-631, 2009.
19. MOREIRA, G.F.; BALBO, A.; ACHETE, C.A.; BARIN, J.S.; WOLLINGER, W., NOGUEIRA, R.; BITTENCOURT, C.F.; RODRIGUES, J. M. Aplicação da calorimetria exploratória diferencial (DSC) para determinação de pureza de fármacos. P&P, v.11, n.1, p.22-29, 2010.
20. RODOMONTE, A.L.; MONTINARO, A.; BARTOLOMEI, M. Uncertainty evaluation in the chloroquine phosphate potentiometric titration: application of three different approaches. J. Pharm. Biom. Anal., v.42, n.1, p.56-63, 2006.
21. SMITH, R.J.; WEBB, M.L., (Eds.). Analysis of drug impurities. Singapore: Blackwell Publishing, 2007. p.12.
22. STULZER, H.K.; SILVA, M.A.S. Estudo de estabilidade de grânulos revestidos e comprimidos contendo captopril. Acta Farm. Bonaer., v.25, n.4, p.497-504, 2006.
23. UNITED STATES PHARMACOPEIAL CONVENTION. Available at: http://www.usp.org. Accessed on: 21 apr. 2010.
24. WILLIAMS, R.L.; PROJECT TEAM 4. Official USP reference standards: metrology concepts, overview, and scientific issues and opportunities. J. Pharm. Biomed. Anal., v.40, n.1, p.3-15, 2006.