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AMPAC Quadruples Analytical Services Capacity

Adds 13,000 sq.-ft. of new lab space

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By: Kristin Brooks

Managing Editor, Contract Pharma

AMPAC Fine Chemicals’ Analytical Business Unit has recently quadrupled analytical services capacity for highly specialized testing, adding 13,000 ft2 of new lab space at a new facility in El Dorado Hills, CA. The company has similar facilities in nearby Rancho Cordova.
 
AMPAC Analytical has also enhanced its specialized analytical testing capabilities to support existing and new U.S. FDA requirements. Included are Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), techniques used for the detection and quantitation of trace elemental impurities.  Added capabilities also include X-Ray Powder Diffraction (XRPD), Particle Size Distribution (PSD), and Dissolution of Drug Product. AMPAC Analytical has also added 10 Ultra Performance Liquid Chromatography (UPLC) units and has expanded stability chamber capacity to support long-term stability testing of drug substances and drug products.
 
“This expansion builds on over 70 years of our chemical production and analytical testing capabilities. We are proud to offer our vast knowledge and know-how in specialized analytical methods development and validation for both Drug Substance and Drug Products to our customers,” said Renato Murrer, executive director of AMPAC Analytical.

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