Organic assay & impurity testing

N-nitrosodimethylamine (NDMA) is reported to be a probable human carcinogen and is related to the widespread recalls of the blood pressure and heart medications losartan, valsartan and irbesartan. It is believed that these drugs were contaminated with cancer related impurities through manufacturing processes at pharmaceutical ingredient plants.

A recent FDA statement about NDMA impurities is that levels have been detected in ranitidine medicines. The FDA is reported to have requested that ranitidine manufacturers conduct laboratory testing to examine levels of NDMA in ranitidine.  

The EMA is reported to have initiated a review of ranitidine medicines after tests showed that some products contained NDMA.

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Capabilities
Not only do LGC have access to the latest state-of-the art analytical equipment, we continually work with instrument manufacturers to push the boundaries of separation sciences. Our scientists combine a wealth of technical expertise with extensive knowledge of industrial and regulatory requirements to support both routine and tailored analytical testing of a broad spectrum of compounds and dosage forms to your specific needs.

Techniques

  • HPLC and UPLC with PDA, MS, UV
  • GC and Headspace GC with FID, ECD, MS (Agilent 7890B GC with Agilent 5977 MSD)
  • High resolution LC-MS
    • Waters Acquity H-Class (PDA) with Waters Synapt G2 Q-TOF MS (with Ion Mobility Separation)
    • Waters Acquity H-Class (PDA) with Waters Xevo G2 XS MS
  • Supercritical fluid chromatography (SFC) with PDA, MS
  • TLC
  • Dissolution
  • Optical Rotation
  • Titration
  • pH
  • Conductivity
  • Karl Fisher

 

Applications

  • ID, potency and purity testing of drug substance and drug product
  • Raw material, excipient and active substance testing
  • Materials testing to USP, EP, BP and JP compendial monographs
  • Full release and in-process testing
  • Phase appropriate method development, optimisation, qualification, validation and transfer
  • Impurity profiles and specification limit development including N-nitrosodimethylamine (NDMA) analysis
  • Genotoxin method development and testing
  • Solubility and dissolution studies
  • Excipient compatibility tests
  • Content and blend uniformity
  • Residual solvents and water content analysis
  • Stability Testing
    • Protocol design
    • Accelerated and long-term stability testing
    • Drug substance stability testing
    • Finished drug product stability testing (solid oral dose, inhaled and nasal, parenteral, topical/creams)
    • Comparator testing and bioequivalence studies
    • Photostability (ICH Q1B)
    • Temperature cycling studies