Elemental Impurities analysis as per USP Chapter <232>&<233> & as per ICH Q3D guideline.
- Our Services
- Elemental Impurities analysis as per USP Chapter <232>&<233> & as per ICH Q3D guideline.
Focus on Impurity Profiling Elemental to Organic
Facility : Received EIR report from USFDA. Maharashtra FDA Approved
Instruments : LC-MS/MS with PDA Detector with chromeleon Software ICP-MS.
Analytical Services
Genotoxic Impurities as per ICH M7 Method Development, Method Validation & Sample Analysis Mass Identification By Direct Infusion & BY LCMSMS
Elemental Analysis Elemental Impurities as per USP<232>/<233> & ICH Q3D guidelines
Extractables & Leachables
Elemental Impurities analysis as per USP Chapter <232>&<233> & as per ICH Q3D guideline.
Elemental Impurity Analysis Requirements
Worldwide, regulatory authorities are responsible for ensuring that pharmaceutical products are both effective and safe. Potentially toxic and harmful contaminants—including elemental impurities—must be identified, and limits defined for the maximum levels that a patient should be exposed to. In February 2017, new procedures for the analysis of elemental (inorganic) impurities in pharmaceutical products and ingredients were finalized. Existing wet chemical and colorimetric tests, such as European Pharmacopoeia Heavy Metals chapter 2.4.8 and United States Pharmacopeial Convention (USP) General Chapter <231>, have been replaced with instrumental methods. These methods provide specific, quantitative determination of individual elemental impurities in drug products and ingredients.
Nalanda Research Laboratories has made the decision to provide ICP-MS analysis rather than ICP-OES in preparation of upcoming regulatory changes. Heavy Metals Analysis (USP <231>) will be replaced with Elemental Impurity Methods USP <232> and USP <233>. Additionally, it is anticipated that individual USP Metal Methods will be eliminated as well; these include USP <251> Lead, USP <211> Arsenic, and USP <261> Mercury. The effect of the elimination of these chapters to monographs that include them is current under review.
While the pharmaceutical industry adapts to these changing standards, Nalanda Research Laboratories can provide analysis under the guidelines of USP <232> and USP <233> now. Excipients, Raw Materials, Drug Product, or Finished Product can all be analyzed in anticipation of the future regulations and determinations can be made as to future compliance with USP <232> and USP <233>.
For more information on how Nalanda Research Laboratories can assist you with your next ICP-MS analysis, or for compliance with USP <232> and USP <233>,
