Validation of Analytical Methods

Rapra Pharma can carry out full analytical method validation as detailed in the ICH (Topic Q2B) and USP Guidelines. The requisite parameters form part of the validation exercise and include:

• Specificity
• Linearity
• Range
• Accuracy
• Precision
  • Repeatability
  • Intermediate Precision
  • Reproducibility
• Detection Limit
• Quantification Limit
• Robustness
• System Suitability

All validation exercises are conducted in accordance with a full validation protocol which is generated by either Rapra Pharma, or the client, in advance of work commencing.

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