Laboratório Exata



Impurities in drug products - USP <232> and <233>

Impurities in drug products - USP <232> and <233>
              Exact Laboratory is prepared to analyze impurities in drugs following USP <232> and <233>.
                In January 2018 came into force the USP <232> and <233> standards for the control of impurities in medicines. In order to meet this analytical demand, the Exact Laboratory acquired two inductively coupled plasma mass spectrometers (ICP-MS), which together with the ICP-OES will meet this standard in full.

Commonly Analyzed Elements
USP <232> / ICH Q3D Elemental Impurities
(Class 1): Arsenic, Cadmium, Lead, Mercury
(Class 2A): Cobalt, Molybdenum, Selenium, Vanadium
(Class 2B): Gold, Iridium, Osmium, Palladium, Platinum, Rhodium, Ruthenium, Silver, Thallium
(Class 3): Antimony, Barium, Chromium, Copper, Lithium, Nickel, Tin

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