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ESTIMATION OF GENOTOXIC IMPURITIES BY CHROMATOGRAPHIC TECHNIQUES

Journal Name:

  • The International Journal of Pharmaceutical Research and Bio-Science

Publication Year:

  • 2013

Key Words:

Author Name
Abstract (2. Language): 
In addition to the challenge of setting a more pragmatic limit for GIs, the development of extremely sensitive and robust analytical methods that can adequately monitor GIs at very low levels is very difficult. Also, the pharmaceutical industry has no long-term experience in the use of these methodologies within the factory setting. Thus, analysts make attempts to determine a way for analyzing various GIs by using unique robust methods as far as possible. In this way, simple HPLC/UV or GC/FID methods are usually performed at the first stage, while more complicated LC/MS or LC/MS/MS methods are used as alternatives studied the formation of sulfonate esters as a mechanistic view, and showed that when a slight excess of base is present, there is no discernible reaction rate to form the sulfonate ester and no mechanistic pathway to their formation. From this point of view, the formation of GIs and suspicious substances in the API syntheses can be easily avoided, and therefore this is the preferred option (Robinson, 2010).Finally, it can be mentioned that in such a situation, in silico approaches can prove to be more effective solution in terms of time and cost for screening genotoxic compounds. As subjected by Luis and Valerio (2009), high-quality experimental data must be used. In addition, for non-genotoxic carcinogens, QSAR studies can provide a better understanding about the mechanism of carcinogenesis of these compounds. The in silico methods used in agencies have not been specified yet; however, by overcoming the limits these can become an innate part of regulatory systems.
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  • 3
306-324
  • English

REFERENCES

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Review Article
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