Solutions for pharma QA/QC GMP testing

Quality control (QC) testing of pharmaceuticals must be rigorous and involves multiple techniques including GC/MS, LC/MS, and elemental analysis techniques. Impurities can take many forms, from solids to volatiles and everything in between. We have solutions for pharmaceutical testing organizations conducting small molecule impurities; from heavy metals to extractables and leachables.

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Compliant technology for heavy metal impurities following USP <232>, <233> and ICH Q3D.

Proven, simple, compliant USP <467> and ICH Q3C workflows for organic volatile impurities.

Identify complex semi-volatile organic impurities with highly selective and sensitive Orbitrap based mass spectrometry.

Identify everything with powerful high resolution accurate mass (HRAM) Orbitrap based mass spectrometry systems and expansive spectral libraries.

Screen and accurately quantify drug counterions and ionic impurities with novel ion chromatography solutions.

Extract, identify and quantify leachables with advanced sample prep, GC/MS, LC/MS, IC/MS and ICP/MS capabilities.

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