
Analytical Unit for
Dissolution Profile Studies
A dissolution profile is an "in vitro" methodology used to compare a medication with a reference or "innovator" drug that has undergone comprehensive clinical studies during its development process. This comparison aims to establish whether the medication you are consuming is equally safe and effective as the innovator, ensuring that neither should trigger adverse reactions.
At Lambda, we have a dedicated Dissolution Profile Unit comprised of experienced professionals who adhere to the requirements outlined in NOM-177-SSA1-2013. This regulation sets forth the tests and procedures necessary to demonstrate the interchangeability of medications.
Currently, Lambda serves as an Authorized Third Party, assisting in health regulation, conducting technical capacity assessments, and ensuring probity as an Analytical Unit for Dissolution Profiles, all to validate the interchangeability of medications—a designation granted by COFEPRIS.