Metrics Adds Analytical Instrumentation for Elemental Impurity TestingBy
Metrics Contract Services, a contract development and manufacturing organization based in Greenville, North Carolina, and part of the specialtypharmaceutical company, Mayne Pharma, has purchased analytical laboratory equipment for elemental impurity testing. Metrics has added to its analytical laboratory a Thermo Scientific iCAP Q ICP-MS mass spectrometer and a Milestone UltraWAVE Single Reaction Chamber digestion vessel, an investment of about $200,000.
The company's capital improvement comes as the pharmaceutical industry faces changes from the US Pharmacopeial Convention (USP) concerning the testing of elemental impurities. The new USP 232 and 233 guidelines, which take effect in December, require that finished drug products meet stricter minimal contamination levels for elemental impurities such as arsenic and mercury. Previously, industry testing for impurities typically was limited to a few compendial procedures in excipients, residual catalysts, and a metal detector at the end of production to check for stray shards.
Source: Metrics Contract Services