Pharmaceutical Regulatory Affairs: Open Access

Reddy MM

Publications

• Review Article
  Harmonized Guideline on Limit and Testing of Elemental Impurities in Pharmaceutical Substances: A Review
  Author(s): Reddy MM, Reddy KH and Reddy MUReddy MM, Reddy KH and Reddy MU
  
  Testing of elemental impurities as heavy metals has been in use for many years. Lack of sensitivity and reproducibility are the main limitations of current heavy metals procedure USP <231>. The procedure described for heavy metals will detect Pb, Hg, Bi, As, Sb, Sn, Cd, Ag, Cu and Mo. The new chapters are designed for safer limits and enhanced detection limits. ICH was proposed a draft consensus guideline and under step 2b version in the year 2013 and posted as official from December 2014 under step 4 version. EMEA released a comment by stating that new marketing authorization for new product should comply with ICH/CHMP guideline effective from June 2016; where a control of an elemental impurity is warranted, an elemental specific method is .. Read More»
  DOI: 10.4172/2167-7689.1000168

  Abstract PDF