Brochure | December 10, 2018

Elemental Impurities Analysis And Measurement

Source: Nitto Avecia Pharma Services

USP has announced the new required methodology proposed to replace General Chapter <231>, Heavy Metals.

In an effort to improve and modernize the USP General Chapter for Heavy Metals <231>, USP has proposed the addition of two new General Chapters and one Supplemental General Chapter.

  • <233> Elemental Impurities – Procedure
  • <232> Elemental Impurities – Limits
  • <2232> Elemental Contaminants in Dietary Supplements

The updated methodologies utilize modern technologies to provide better precision and yield higher recoveries. To comply with these changes, drug products will be required to fall within the proposed limits. General Chapters <232> and <233> implementation date is proposed for January, 2018.

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