03.30.15
Metrics Contract Services has invested about $200,000 to add a Thermo Scientific iCAP Q ICP-MS mass spectrometer and a Milestone UltraWAVE Single Reaction Chamber digestion vessel to its analytical lab.
The investment follows 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.
“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, 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.”
The investment follows 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.
“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, 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.”