Methodology Development
and Validation
Method development primarily involves the identification, purity assessment, and concentration determination by separating and characterizing impurities and degradation products. This process utilizes the most suitable techniques tailored to the nature of the active ingredients and the specific requirements of our clients.
Analytical method validation is an indispensable component of method development. It serves to confirm the suitability of an analytical procedure for its intended purpose. The results obtained from method validation enable us to evaluate the quality, reliability, and consistency of analytical outcomes, forming an integral part of sound analytical practices.
Analytical methods should undergo validation or revalidation in the following scenarios:
- Prior to their routine implementation.
- Whenever there are changes in the conditions for which the method was initially validated (e.g., using different instrumentation with varying characteristics or samples with distinct matrices).
- Whenever the method undergoes modifications that extend beyond its original scope.
Lambda boasts a team of highly proficient professionals specializing in the development, optimization, and validation of analytical methods. Our commitment extends to technology transfer, ensuring the dissemination of knowledge acquired throughout the entire process.
With years of experience, Lambda has consistently delivered excellence in method development and validation, adhering rigorously to Good Laboratory Practices to meet the stringent requirements of the Pharmaceutical Industry. This extensive expertise is the cornerstone of our success in this domain.