and Validation

Method Development and Validation

At GVK BIO, we develop product specific analytical methods, which are best suitable for the intended use of the application with an approach of ‘right first time’. We help our partners globally to develop various analytical methods at an efficient cost while meeting global quality and regulatory standards. Some of our capabilities are mentioned below:

  • Delivered 1000+ analytical methods through HPLC, GC, GCMS, LCMS, ICPMS techniques
  • Analytical method validations are executed in alignment with stringent SOP, which is based on ICH Q2, Anvisa guidelines and in adherence to cGMP and GLP requirements
  • All the analytical methods are transferred through protocol bound study as per the latest regulatory guidelines such as USP (1224)
  • Development and validation studies are designed as per ICH and/or USP <232 >/ <233> for APIs, intermediates and drug products
  • Nitrosamines testing and validation

Solutions we offer

  • Expertise in developing and validating analytical methods for Pharmaceutical APIs, finished pharmaceutical products (solid and liquid preparations) for tests like assay, degradation products, enantiomeric excess and residual solvents. It also includes tests for preservative content by HPLC and GC; elemental impurities by ICPMS; genotoxic impurities by GCMS and LCMS; nitrosamine impurities by GCMS and LCMS (as per US-FDA/EMA); particle size distribution; In-vitro multimedia dissolutions; microbiology, physicochemical and wet chemical methods
  • Solid State Characterization: Expertise in solid state characterization viz. XRD, DSC, PSA and TGA. It also includes method development and validation along with batch release of corresponding methods
  • Validation experimentation: This includes all the quantitative and qualitative tests by following guidelines like ICH, 21CFR, Eudralex and ANVISA. The key parameters considered during validation but not limited to:
    • Specificity which includes stress studies
    • System precision
    • Method precision
    • Accuracy
    • Linearity
    • Quantitation limit/Detection limit
    • Ruggedness and robustness studies
  • Elemental analysis: Expertise to perform analysis for all ICH Q3D elements (24 metals) viz. Class 1, 2A, 2B and 3 like : Aluminium (Al), Boron (B), Calcium (Ca), Iron (Fe), Potassium (K), Magnesium (Mg), Manganese (Mn), Sodium (Na), Tungsten (W), and Zinc (Zn)
  • Microbiology: Microbial limit tests, Microbial contaminant identification, sterility, PET/AET, bacterial endotoxin (gel clot method) and environmental monitoring


Formulation & Analytical Solutions

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Developability Assessment of Small Molecules

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