Pharmaceutical Quality Control Testing

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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Improve pharma and biotech manufacturing processes and help ensure patient safety

Save time, improve processes, protect brand integrity, and ensure patient safety, from raw material identification through the pharmaceutical manufacturing process, to finished and packaged pharmaceutical product inspection.

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Application - The product is For General Lab Use Only - Not For Diagnostic Procedures

Our General Purpose product-lines are not intended for in vitro diagnostic purposes in accordance with our product documentation, manuals, and labels. They are designated for General Laboratory Use Only.

Our Products have not been tested or validated for such applications and their use for in vitro diagnostic purposes may result in inaccurate results and, more seriously, health and safety risks.

 

The product is For General Lab Use Only - Not For Diagnostic Procedures. The application is For Research Use Only. Not for use in diagnostic procedures.