As part of the pharmaceutical product development process, all analytical methods are validated as per the ICH guidelines.  Compendial methods when used for analysis of stability samples are also validated as per ICH guidelines.  The following parameters are challenged during the validation process.

• Linearity
• System Precision
• Method Precision - Repeatability
• Intermediate Precision
• Accuracy
• Range
• Detection Limit
• Quantitation Limit
• Specificity
• Robustness
• Stability of Standard Preparations
• Stability of Sample Preparations
• Equivalency to compendia methods (if any) 

ANALYTICAL METHODS

DEVELOPMENT AND

SERVICE

Analytical Methods Development and Validation