USP 232/233: Elemental Impurities in Drugs

USP 232/233: Elemental Impurities in Drugs

Image Credit: Jordi Labs

The FDA requires drug manufacturers to comply with the standards for elemental impurities. These impurities cover those that are added to the product during the process of manufacturing or those that naturally occur in the product.

The team of PhD chemists at Jordi Labs specializes in USP 232/233/2232 testing. A selection of research from Jordi Labs is detailed below:

  • Case Study: Identify USP 232 Impurities in Drug Delivery Systems
  • Elemental impurities testing services
  • Regulatory testing services

Guidance for elemental impurities was previously found in ICH QD3 before the implementation of USP 232 and 233.

This document outlined the permitted daily exposure (PDE) for 24 toxic metals.

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About Jordi Labs

Jordi Labs provides the highest quality contract analytical services and polymer HPLC columns to some of the world’s leading consumer products, polymers, pharmaceutical and medical device manufacturers. Our team of PhD analytical chemists specialize in chemical identification. One of core competencies is Extractables & Leachables testing.

We are also worldwide leaders in;

  • Particulates & residue analysis
  • Good-bad comparisons
  • Method development/validation
  • Polymer analysis
  • Polymer failure

We also help companies from Fortune 500s to innovative startups with method development, preparative HPLC, training seminars, depositions and consulting. As a family company, we take pride in the production of all of our products and analytical service offerings. It is our goal to help our customers overcome their analytical challenges by providing excellent products and personal assistance from our highly-trained staff of PhD chemists

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Last updated: Oct 1, 2020 at 5:09 AM


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