Pharmaceutical Quality Control Testing
Solutions for pharma QA/QC GMP testing
Regulatory authorities such as the FDA and EMA tightly control the manufacture of pharmaceutical and biopharmaceutical drugs. Quality control (QC) testing 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 a unique portfolio of products and solutions for pharmaceutical quality control testing from elemental impurities to extractables and leachables.
Featured pharmaceutical quality control testing categories
Get information on the latest compliant technology and software for analyzing pharmaceutical heavy metal impurities following USP <232>, <233> and ICH Q3D.
Residual solvents and other volatiles can be toxic to the patient or can affect drug efficacy. Explore our proven, simple, compliant USP <467> and ICH Q3C workflows for organic volatile impurities that follow regulatory guidelines.
The identification and quantification of semi-volatile organic impurities requires high selectivity and sensitivity. Orbitrap-based mass spectrometry combined with advanced software offers unparalleled capabilities.
Non-volatile pharmaceutical impurities such as those from container-closure systems can be hard to identify. However, our powerful high resolution accurate mass (HRAM) Orbitrap-based mass spectrometry systems coupled with expansive spectral libraries allow for easier, unambiguous identification.
Many pharmaceutical products are formulated as salts. Inorganic and organic ions may be added as pharmaceutical counter ions to alter specific properties of the drug. Effective screening of drugs to identify these counter ions is a critical step in the quality control process.
Extractable and leachable compounds can be difficult and time consuming to identify using traditional techniques such as reflux extraction. We offer a range of faster and more powerful solutions such as accelerated solvent extraction.
Unknown impurity identification and quantification workflows for:
- Pharmaceutical, packaging, and contact-closure materials
- Food contact materials
- Non-intentionally added substances