Analytical Method Validation

Analytical method validation is the process which demonstrates that a specific method is suitable for its intended use. The validation process is product- and method-specific and composed of a series of tests. Once the validation process is complete it proves that the method provides reliable results and can be used to test the product.

 

Validation characteristics are chosen according to the method and on a case to case basis. Typical validation characteristics according to the FDA/ICH guidelines are Specificity, Linearity, Accuracy, Precision, Range, Quantitation limit, and Detection limit.

 

          Tip from our scientists

Validation is performed on a well-defined procedure. Even small changes in instruments, formulation and other conditions can lead to re-validation of the method (which may be long and costly). Before starting your validation make sure that your analytical method is fully developed and that the product development is complete.

 

Services for you

  • Development and validation of methods for determination of the active material concentration in the finished product (Assay).

  • Development and validation of Stability Indicating Methods (SIM) including photostability, sensitivity to acidic or basic conditions, UV radiation, etc. using forced degradation studies.

  • Development and validation of methods for the detection of Impurities and Degradation products (ID).

  • Stability testing including storage in environmentally controlled chambers with 24/7 monitoring for all ICH climate conditions.

  • Development and validation of dissolution and drug release profiling methods.

  • Development and validation of Leachables and extractables methods (the study of potential materials resulting from the interaction between the drug product and its containers).

  • QC services (click here for the full QC tests list).

  • For a full list of our analytical instruments, click here.

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