NOW IN EFFECT: REVISED USP <231> TO INCLUDE <232> AND <233> FOR ELEMENTAL ANALYSIS FOR DRUG PRODUCTS, DRUG SUBSTANCES, EXCIPIENTS, AND DIETARY SUPPLEMENTS

NOW IN EFFECT: REVISED USP <231> TO INCLUDE <232> AND <233> FOR ELEMENTAL ANALYSIS FOR DRUG PRODUCTS, DRUG SUBSTANCES, EXCIPIENTS, AND DIETARY SUPPLEMENTS

What has changed?

Starting January 1, 2018, the U.S. Pharmacopeia (USP) phased out heavy metals testing using wet chemistry (described in <231>) to a modern/instrument-based approach described in USP General Chapters <232> and <233> Elemental Impurities Limits and Procedures. Using Inductively Coupled Plasma (ICP), blessed by the USP, provides sensitivity and accuracy necessary to quantitate the presence of metals in pharmaceutical drug products, drug substances, excipients, and dietary supplements.

Elements to Consider (per ICH Q3D and USP <232>)

Parenteral Products: 10 Elements such as Cd, Pb, As, Hg, Co,, V, Ni, Li, Sb, Cu.

Oral Products: 7 Elements such as Cd, Pb, As, Hg, Coo, V, Ni

Same profile for Drug Substance (API) and Excipients. 

NOTE: The UCH Q3D contains a list of 24 Elements, however you're only required to monitor for intended products above.

How XEO CAN HELP?

Partner with XEO to obtain trusted and speedy results.

We offer:

  • General Testing & R&D Screening
  • Method Development and Validation

 XEO uses a Varian ICP-oES and ICP-MS to screen and quantitate presence of elemental impurities of interest.