Metrics Contract Services Invests in Equipment to Help Clients Meet New USP for Impurities

Metrics Contract Services (Metrics) has purchased state-of-the-art analytical laboratory equipment to better serve pharmaceutical clients whose drug products now must undergo heightened elemental impurities testing, thanks to new international guidelines.

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 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.

“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,” said Daniel Ingles, MS, Team Leader for Trace Elements at Metrics. “Practically speaking, however, this work requires specialized equipment for both preparation and analysis that many pharmaceutical labs simply don’t have. Metrics has always been able to perform this kind of work, and thanks to these most recent investments in equipment, we now can do it even more quickly.”

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-sensitive, DEA-regulated, and other challenging molecules.

“Since our start, Metrics has operated a dedicated trace elements laboratory staffed by experienced scientists,” Ingles said. “While the new USP guidelines represent a step into unfamiliar territory for several manufacturers, Metrics is well positioned to seamlessly adopt the new rules, thanks to having the necessary expertise and equipment.”

Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization serving clients worldwide. It delivers proven scientific and operational excellence for solid oral dosage forms. Its areas of expertise include quality formulation development; first-time-in-man formulations; Phase I-III clinical trial materials manufacturing; and analytical method development and validation services leading to commercial scale manufacturing. For more information, visit www.metricsinc.com.

Mayne Pharma is a publicly traded specialty pharmaceutical company listed on the Australian Securities Exchange (ASX: MYX). 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. For more information, visit www.maynepharma.com.