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Elemental Impurities

Elemental Impurities

USP Has Announced the New Required Methodology to Replace the General Chapter for Heavy Metals <231>

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.

Who Will Be Required to Comply?

  • Pharmaceutical
  • Biopharmaceutical
  • Excipient
  • Medical Device
  • Nutraceutical

How Can Avecia Pharma Help You Prepare?

Avecia Pharma has nearly 30 years of analytical experience with <231> Heavy Metals. Additionally, Avecia Pharma has over ten years experience working towards developing new methodologies. Avecia Pharma has actively participated in the industry for years on this subject matter via technical posters, papers, presentations, and through helping clients.

Utilizing Modern, Precise Instrumentation

  • ICP-MS
  • Graphite AA
  • Flame AA
  • Cold Vapor AA

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