scholarly journals The applicability of solid state characterization and analytical techniques for reference chemical substance certification: Resolution of the Collegiate Board (RDC) 166/2017 by National Health Surveillance Agency (ANVISA)

Author(s):  
Renan Dezena

Reference chemical substances called primary reference are used which are marketed by official compendia both nationally and internationally in the pharmaceutical industry as a tool for identification and quantification during pre-formulation, development/analytical validation and quality control studies. The reference or primary standards are almost always imported and resold in the Brazilian market as a consequence, increasing the cost in relation to the sample amount (little amount of mass in mg per bottle). On July 24, 2017, the National Health Surveillance Agency (ANVISA) published the Resolution of the Collegiate Board (RDC) number 166, which deals with the validation of analytical methods. The Chapter III of this resolution is intended for reference chemical substances and, in Art. 14 § 1, the RDC 166/2017 allows the use of characterized reference chemical substances in the analytical validations. The characterization study is planned according to the chemical structure of the substance to be characterized and within this new regulation, solid-state characterization and analytical chemistry stands out as an essential ally corroborating with the evolution of the number of publications in the literature regarding this subject in the google scholar database as shown in Figures 1 and 2.

2021 ◽  
Vol 21 (2) ◽  
pp. 1202-1217
Author(s):  
Yuntian Xiao ◽  
Ling Zhou ◽  
Hongxun Hao ◽  
Ying Bao ◽  
Qiuxiang Yin ◽  
...  

2010 ◽  
Vol 99 (9) ◽  
pp. 3684-3697 ◽  
Author(s):  
Faraj Atassi ◽  
Chen Mao ◽  
Ahmad S. Masadeh ◽  
Stephen R. Byrn

1998 ◽  
Vol 62 (5) ◽  
pp. 581-583
Author(s):  
Simon A. T. Redfern

How can the equilibrium and non-equilibrium thermodynamics of minerals be understood from their atomic-scale structural features? How can they be predicted, simply from models for the forces between atoms? Advances in analytical theory, statistical mechanics, experimental solid-state science, computational power, and the sophistication of a mineralogical approach that brings all of these together, means that these questions, once imponderable, are now realistically tractable. These questions have been exercising the minds of mineralogists over the last decade or so, and have motivated many developments in the science. Acting as way-markers along the path, there are a number of publications which have followed from meetings where these questions have been addressed. It is now twelve years since the publication of Microscopic to Macroscopic, an edition of Reviews in Mineralogy (Kieffer and Navrotsky, 1985) that sought to identify the fundamental controls on the bulk properties of minerals in terms of their atomic-scale characteristics.


Steroids ◽  
2011 ◽  
Vol 76 (3) ◽  
pp. 261-268 ◽  
Author(s):  
Kari V. Ahonen ◽  
Manu K. Lahtinen ◽  
Arto M. Valkonen ◽  
Martin Dračínský ◽  
Erkki T. Kolehmainen

2013 ◽  
Vol 1049 ◽  
pp. 1-6 ◽  
Author(s):  
Irlene Maria Pereira e Silva ◽  
Daniel de Moraes Profirio ◽  
Raphael Enoque Ferraz de Paiva ◽  
Marcelo Lancellotti ◽  
André Luiz Barboza Formiga ◽  
...  

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