Method Development and Validation

Analytical method development and validation are
continuous and interconnected activities conducted throughout the drug
development process. The practice of validation verifies that a given method
measures a parameter as intended and establishes the performance limits of the

Method development is the creation of a set of experimental conditions to perform analytical procedures in chemical samples. Developed analytical methods can be used to identify, separate, quantify, and learn more about the chemical components in drug products intended for commercial manufacturing .developing an HPLC method involves four basic steps: scouting, optimization, robustness testing, and validation. Learn best practices for sample preparation plus expert tips and tricks for developing an HPLC method.

Method development is the cornerstone of medical device and pharmaceutical development. It is often one of the first steps in identifying and understanding the chemical nature of a target molecule or material. It can also be used to identify potential impurities or degradants in a formulation.

The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. A tabular summation of the characteristics applicable to identification, control of impurities and assay procedures is included.

  • Be Clear about what you need….at beginning as for what method requirement is?
    • Assay/CU
    • RS
    • Dissolution
    • Reaction Monitoring
    • N-1 or N-2 Monitoring
    • Final Drug Substance Release,
    • Estimation form Biological samples

Step of method development

  • Literature search
  • Stationary Phase
  • Solvent (mobile phase optimization)
  • pH
  • Method Development Strategy

Below Services are available:

  • Method Development
  • Method Validation

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