Putting Science to Work
Analytical Method Development & Validation

Analytical Method Development and Validation

Analytical Method Development & Validation

Syngene offers complete analytical support for product development including quality control (QC) support for current good manufacturing practice (cGMP) activities such as validation, ICH stability studies and release testing of clinical supplies.

Our offerings include:

Analytical Method Development
  • Assay, purity, dissolution testing
  • Forced degradation studies
  • Impurity identification and characterization
  • Cleaning verification
  • Microbiological testing
  • Stability testing and routine analysis
Analytical Method Validation
  • Specificity
  • Accuracy
  • Precision
  • Quantitation limit
  • Linearity
  • Solution stability
  • Detection limit
  • Range
  • Robustness
  • System suitability testing

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