Free webinar addresses the new US Pharmacopeia (USP) standards setting limits for the presence of heavy metals in APIs and excipients
Date: Thursday December 6th
Time: 3pm UK / 4pm CET / 10am EST
Registration: Register Now!
Intertek is pleased to invite you to attend our free webinar ‘The changing landscape of metals testing for the pharmaceutical industry’.
The US Pharmacopeia (USP) standards, <232> Elemental Impurities – Limits and <233> Elemental Impurities – Procedures, outline procedures on how to detect common impurities and sets limits on the presence of impurities to protect consumers from exposure. The new standards expand upon and will eventually replace USP standard <231>, which sets limits for the presence of heavy metals in active pharmaceutical ingredients and excipients. The standards will be made official on 1 December 2012, but enforcement of the standards will be delayed until 1 May 2014.
Dan Zuccarello, Intertek's Director of Operations, Intertek Pharmaceutical Services, New Jersey, USA will deliver a comprehensive review of how the standards and expectations for trace metals pharmaceutical testing has evolved and the driving forces for this change. Dan will also provide an update on the relevant methods, instrumentation, techniques and validation strategies with reference to several case studies on product analysis and extractables / leachables studies.
Please register via this registration form: http://www.intertek.com/pharmaceutical/metals-testing-webinar-registration/
Intertek has more than 20 years’ experience with inductively Coupled Plasma (ICP) analysis. Intertek's routine services in Europe and the US for trace metals testing by ICP-OES or ICP-MS can be applied to R&D, extractables/leachables, Quality Control analysis and GMP batch release testing.