In January 2018, new guidelines for identifying elemental impurities in drug substances, excipients, and drug products came into effect.

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Ensuring Compliance with Expert Elemental Impurities Consulting.
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Scientech consults with its partners and clients on the requirement of types of Elemental Impurity analysis.  

  • Compendial & Non-Compendial Consulting 
  • Pharmaceutical Drug Batch Release Consulting & Testing 
  • Reference Standard Characterization & Management 
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USP <232> and ICH Q3D sets forth specifications for drug products which involves the determination of metallic impurities in APIs and excipients.

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