Microbial Identification Methods in Pharmaceutical Analysis: Comparison and Evaluation

Scientific Centre for Expert Evaluation of Medicinal Products. The Ministry of health of Russia. Petrovsky Boulevard 8, 127051 Moscow, Russia.
Corresponding Author:Sakhno NG, Scientific Centre for Expert Evaluation of Medicinal Products. The Ministry of health of Russia. Petrovsky boulevard 8, 127051 Moscow, Russia,Tel: +7-916-561-52-94; E-Mail: [email protected]
Received Date: 04 Feb 2016 
Accepted Date: 08 Feb 2016   
Published Date: 12 Feb 2016
Copyright © 2016 Sakhno NG
Citation: Sakhno NG and Gunar OV. (2016). Microbial Identification Methods in Pharmaceutical Analysis: Comparison and Evaluation. Mathews J Pharm Sci. 1(1): 001.

ABSTRACT:

Rapid and accurate identification of microorganisms is an essential part of pharmaceutical analysis. Contaminants found in ingredients, water for pharmaceutical use, the manufacturing environment, intermediates, and finished products are identified to assist in product investigations. There are number of phenotypic, genotypic and proteotypic methods. A comparison of the database size of representative methods, as well as accuracy of these systems is presented in the review. Emphasis is given to the features of methods and factors affecting the result of identification. Some species of microorganisms within one genus, which determination is problematic from both a genotypic and a phenotypic perspective, are discussed in details. Validation of identification methods is the most important and challenging part of proper automated system choice. Approaches to the evaluation of the system are highlighted in the review.

KEYWORDS:
Pharmaceutical analysis; Methods of microbial identification; Database; Accuracy; Validation.