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Development / validation of processes and techniques

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Our laboratory validates analytical procedures according to the requirements of ICH, Pharmacopoeia of Ukraine, USP. Validation may include next parameters:

  • Accuracy
  • Linearity and range
  • Specificity – components of the matrix
  • Specificity – Product degradation
  • Robustness
  • Limit of detection limit (LOD), Limit of quantification (LOQ)
  • Stability of standard and test solutions
  • Precision

Central Laboratory offers development and optimization of analytical procedures in the following areas:

  • Quantitative tests, impurity tests, stability testing methods
  • Techniques for dissolution test, dissolution profile comparison techniques
  • Residual solvents
  • Methods for validation of the cleaning processes for equipment or glassware

Our principles on development of analytical procedures:

  • Minimal time for analysis
  • Minimal use of organic components and ecological safety of developed procedures
  • Chromatographic conditions should be “friendly” to your hplc-column
  • Minimal costs for analysis by means of developed procedure
  • Procedure should be reliable and robust

 

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