Validation of Analytical Procedures: Part 1

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Types of Analytical Procedures

Category I: Identification Test 

To ensure the identity of an analyte in a sample.

  • Comparison of a property of the sample to that of a reference standard.
  • To differentiate compounds of closely related structures which are expected to be present.

Category II: Impurities Test (Quantitative)

Quantitative determination of impurities.

  • Determination of impurities in a drug substance or degradation compounds in drug product.

Category II: Impurities Test (Limit)

  • Limit control of impurities.
  • To accurately reflect the purity characteristics of a sample.
  • Related substances, residual solvents content, heavy metals, etc.

Assay Test (Quantitative) 

To measure the analyte present in a sample.

  • Quantitative tests of the active moeity, major components of the drug substance (DS)/drug product (DP).
  • Potency assay, content uniformity.
  • Dissolution: determination of the performance characteristic (drug release) of the product.

Once the analytics method type/category is assessed, determine which validation parameters should be evaluated. 

The experts at Pharmatech Associates can help you determine the analytical procedure that best fits your drug’s, biologic’s, or medical device’s development process. Contact us today!

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