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Follow on Google News | Metrics Contract Services invests in equipment to help clients meet new USP rules for impuritiesAlready known and respected for its analytical capabilities, Metrics Contract Services has purchased new equipment that will speed testing for elemental impurities per new international guidelines
By: Metrics Inc. 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 substantive changes from the U.S. 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. “Testing for elemental impurities is like any other analytical procedure — the scientist prepares a sample, tests it on an instrument versus calibration standards, and then calculates and reports the level of impurities,” Founded in 1994 as an analytical laboratory, Metrics has long understood the importance of analytical support to pharmaceutical development and manufacturing. Today Metrics is a full-fledged contract development and manufacturing organization with more than 90 analytical chemists on staff — representing about four analytical chemists for every one scientist or developmental specialist. The company appoints a lead analytical scientist to serve as each client’s point of contact to ensure that quality science remains at the forefront of projects. Staff members work within a current Good Manufacturing Practices-complaint facility on a wide range of compound types including potent, cytotoxic, light-sensitive, temperature- “Since our start, Metrics has operated a dedicated trace elements laboratory staffed by experienced scientists,” About Metrics Contract Services Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization serving clients worldwide. We deliver proven scientific and operational excellence for solid oral dosage forms. Our areas of expertise include quality formulation development; Located in Greenville, N.C., Metrics Contract Services is a proud member of the Mayne Pharma family. Learn more online. About Mayne Pharma Mayne Pharma is a publicly traded specialty pharmaceutical company listed on the Australian Securities Exchange. The company develops and manufactures branded and generic product globally – either directly or through distribution partners – while applying its drug-delivery expertise for contract development and manufacturing services. Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems, and these technologies have been successfully commercialized in numerous products that have been marketed around the world. Mayne Pharma has drug development and manufacturing facilities in Salisbury, Australia, with expertise in formulating complex oral dose forms, including controlled substances, modified release products and inherently unstable compounds. End
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