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Whitehouse Labs Bolsters Impurity Testing Capacity

Adds new mass spectrometer to detect contaminating trace metals at levels as low as parts per trillion

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By: Kristin Brooks

Managing Editor, Contract Pharma

Whitehouse Labs, a division of AMRI, has expanded impurity testing capacity in its Lebanon, NJ, facility with the addition of an Agilent 7900 ICP-MS (inductively coupled plasma mass spectrophotometer) system.

The ICP-MS systems have the capability to detect contaminating trace metals at levels as low as parts per trillion, a key requirement for testing of drug products and active pharmaceutical ingredients.

In addition, the company now has the capability and qualifications to test potent substances, which require additional specialized equipment, including a Labconco Xpert Weigh Box laminar flow hood, and its technicians use UltraWAVE microwave digestion system for difficult samples.

“Ensuring drug products are free from contaminating substances is a critical function, and our clients’ demand for this vital service is increasing, so we are increasing our capacity by 50 percent,” said Amanda Wohlleber, head of the Lebanon, NJ, facility. “With this specialized equipment, we can provide testing services on the types of substances that are increasingly found in next generation drugs.”

Whitehouse’s ICP-MS systems are in compliance with 21CFR Part 11 regulations, and the company is qualified to perform USP (United States Pharmacopeia) 232 and 233 testing.

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