Analytical Method Development

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

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

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