From The Corner Lab - Blog Posts

Quantex Issues New Guide on Elemental Impurities

Posted by Jim Menoutis on Tue, May 06, 2014 @ 04:13 PM

Quantex Laboratories has just release a new whitepaper/guide on Elemental Impurities, titled "Elemental Impurities -Preparing For The New regulations and Guidelines". It provides a current overiew of Elemental Impurites and what to expect with  the Deceber 2015 implementation date.

The whitepaper/guide provides a review of Current USP requirements for General Chapters <232>, <233> and <2322>. It also details and compares the new European Pharmacopiea  5.20 "Metal Catalysts or Metal Reagents", and 2.4.40 "Determination of Metal Catalysts or Metal Reagent Residues". The paper also covers the the ICH Q3D guidelines.

 

 

 To download your free copy click here

 

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Topics: USP <232> USP <2332>, Elemental Contaminants in Dietary Supplements, Elemental Impurities, USP <232>, USP <233> elemental Impurities, ICH, Q3D

USP Announces Revised Timeline, Effective Date for Elemental Impurities Limits and Procedures

Posted by Jim Menoutis on Fri, Jan 17, 2014 @ 12:32 PM

In September 2013, the Elemental Impurities Expert Panel reviewed the Step 2 limits of the International Conference on Harmonization (ICH) Q3D Elemental Impurities Working Group, which were released in June 2013 and recommended revisions to General Chapter <232> Elemental Impurities—Limits to partially align with the ICH Q3D limits. In October 2013, the General Chapters—Chemical Analysis Expert Committee endorsed the Expert Panel's recommendations.

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Topics: USP <232> USP <2332>, Elemental Contaminants in Dietary Supplements, Elemental Impurities, USP <233> elemental Impurities, ICH, Q3D