Elemental Impurities USP 232 & 233

Below are all of the materials related to the upcoming USP <232> & <233> standards. If you need testing related to USP <232> & <233> click here to request a quote.

Latest Developments

September 2015: The FDA’s Current Position on Elemental Impurities

The FDA released their final updated to Q3D Elemental Impurities, Guidance for Industry. In this final update, the FDA states that the application of Q3D to existing products will not be expected by the FDA within 36 months of the ICH publishing its new guidelines, which were finalized in December of 2014. This fits into the 36-month timeframe to coincide with the USP General Chapter <232> Elemental Impurities application. Click Here to view FDA’s Guidance for Industry.

March 2015: Revised Dates

The USP officially announced a revised date of  January 1, 2018 for the applicability for General Chapter <232>. Additionally, USP announced a revision to General Chapter <231> Heavy Metals to delay its omission until January 1, 2018. They specified that users may either continue to utilize the <231> approach or implement <232> in lieu of <231>.

Revised versions of <232> and <233> Elemental Impurities will appear in the second supplement to USP 38-NF 33 to become official December 1, 2015. It will contain updated limits that align with the ICH Q3D.

January 2015: Date of Applicability

USP announced plans to establish January 1, 2018 as the new date of applicability for General Chapter <232> Elemental Impurities.

April 2014: No Revisions Yet

USP announced that it does not it does not intend to develop USP Reference Standard for the new Elemental Impurities General Chapters at this time. 

Frequently Asked Questions

  1. When will conformance to USP General Chapters <232>, <233> and <2232> be required?

    January 1, 2018 is the date that these General Chapters will be required for drug products and dietary supplement dosage forms.

  2. Are General Chapters <232> Elemental Impurities-Limits, <233> Elemental Impurities-Methods, and <2232> Elemental Contaminants in Dietary Supplements Currently official?

    Yes. These General Chapters became official on August 1, 2013. Until General Notices 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements makes the General Chapters applicable on January 1, 2018 as anticipated, however, these General Chapters would necessarily be applicable only if they are referenced in a particular monograph.

  3. What will happen to USP General Chapter <231> when General Chapters <232>, <233> and <2232> become applicable?

    General Chapter <231> will be omitted and removed from USP-NF when General Chapters <232>, <233> and <2232> become required on January 1, 2018.

  4. Can General Chapters <232> or <2232> be implemented in advance of January 1, 2018?

    USP General Chapters <232> or <2232> can be implemented in lieu of USP <231>.

  5. What analysis technique has RD Laboratories implemented, ICP-MS or ICP-OES for elemental impurities?

    R.D. Laboratories believes that the ICP-MS offers significant sensitivity advantages over ICP-OES. We are currently performing elemental impurities analyses in compliance with the current requirements outlined in USP General Chapters <232> and <233> using a qualified Thermo Scientific X SERIES 2 ICP-MS system. This system offers accurate, multi-element determinations to part-per-billion levels with a wide linear range. For samples that are not easily solubilized, we utilize a CEM Discover SP-D closed-vessel microwave digestion system.

Basic Issues

Advanced Topics

USP <232> & <233> Testing Services

We have the specialized knowledge and equipment to help our customers comply with coming compendia changes for inorganic impurity testing.

Click here to request a quote, or call us at 636-390-2622 with any questions.