Method Development & Validation

Development and/or validation of analytical methods specific to your sample matrix, active ingredient and desired instrumentation.

 

Impact Analytical provides method development for a full range of capabilities and customizes methods for your analyses of interest (API, intermediate, formulation or finished product) and sample matrix. All methods are developed with your end goal in mind – whether it’s validation, transfer, QC usage, cGMP release testing or others.

 

Impact Analytical also offers method validation services for methods developed at Impact Analytical or elsewhere. Our compliance with both GLP and cGMP ensures all validation needs can be met throughout the drug development lifecycle. Validation can be performed in accordance with the client’s SOP or protocol and is done to FDA and/or ICH guidelines. Typical validation elements include:

  • Accuracy

  • Analyst precision

  • Intermediate precision

  • Limit of detection

  • Limit of quantitation

  • Linearity

  • Range

  • Robustness

  • Ruggedness

  • Specificity

  • System suitability

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