The recent changes to the elemental impurities regulation guidelines increase the level of control necessary in testing for heavy metals in pharmaceutical and biotherapeutic products. The use of inductively coupled plasma (ICP) instrumentation is considered the ideal method to determine elemental impurities present in drug products and raw materials. This approach has been proven to be accurate, sensitive, linear, and satisfactory to include in filing reports.
This webinar will discuss:
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Alcami : Jan 24, 2017 9:00:00 AM
In 2013, the International Conference on Harmonization (ICH) approved ICH Q3D, a Guideline for Elemental Impurities, which replaced wet chemistry...
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Alcami : Feb 8, 2017 11:00:00 AM
The U.S. Pharmacopeia (USP) intends to remove the existing wet chemistry heavy metals methods outlined in USP General Chapter <231> by January 2018....
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Alcami : Nov 24, 2020 9:07:36 AM
You're invited to attend our on demand virtual event. During this webinar, scientific experts will highlight several newer applications of ICP-MS in...
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