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(Gold & Silver)

Contract Laboratory Services (CLS) > Pharmaceuticals Analysis >> Method Development, Validation & Transfer >>> Method Selection & Development

Our Method Selection & Development protocol is as follows:

  • Understanding the molecule chemistry and Method application area (routine quality control, stability indicating, screening methodology, confirmatory technique etc.)
  • Method Evolution
  • Identification / Detection Techniques - options and trade-offs; typical applications and sensitivities.
  • Accuracy
  • Precision
  • Linearity
  • Specificity & Resolution (Separations)
  • Sample Preparation & Clean-up (if any) – options and trade-offs; typical recoveries and matrix-effects
  • Optimizing systems
  • Optimizing test procedures
  • Determining LOD, LOQ, MDL
  • Statistical validation
  • Method Stability
  • Robustness (system suitability, system component contributions)
  • Measurement Uncertainty
  • Method Validation
  • Method Transfer

 For more information on validations, email at validations@choksilab.com .

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