Your Guide to USP 232/233 – Changes to Testing for Elemental Impurities in Drug Products

USP 232/233

We’re less than a month away from the deadline to comply with the USP General Chapters <232>/<233>, pertaining to Elemental Impurities in all drug products. Many of our customers are racing to implement the steps for compliance, including performing Risk Assessments, Validations and/or Verifications of methods for testing individual products, and Release Testing.

Chemical Solutions LTD has compiled dozens of resources to help. Our videos, blog posts and training modules will prepare you for what’s to come. Perhaps the most significant resource is our blog post on contending with the looming January 1st deadline, which you can read by clicking here.

Below is a list of additional resources. Simply click on the link to access the resource.

ICH Q3D Training Modules

Validations and Verifications

Dermal Administration

Risk Assessment

Extractables & Leachables

Changes to Testing for Elemental Impurities in Drug Products

Determining Elemental Impurities

If you find yourself in a situation where a validation timeline will extend beyond the January 1st deadline, we may be able to help. Contact us today for more information, as we can assist with formulating a logical plan to meet the critical risk assessment mandate of USP <232><233>, with support of solid analytical data to make keen decisions on future control strategies.


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