Through many years of experience being the API development partner of choice, CARBOGEN AMCIS has a deep and wide understanding of the critical need to perform stability studies as well as forced degradation studies to support drug development.
We have the experience and capability to assess drug storage or shipment conditions, expiration date, and packaging. These studies provide a thorough understanding of the chemical behavior, degradation pathways and the intrinsic stability of a new molecule.
Stability studies are part of a large number of different projects; the possibility of performing analytical work with different molecules and the discovery of their features is a very interesting part of my work.
Katja - Chemist QC&A, Neuland
Our stability studies are performed in fully cGMP validated and mapped stability chambers, which operate at ICH conditions (25°C/60% RH, 30°C/65% RH, 30°C/75% RH and 40°C/75% RH) and at low temperatures (5°C, -20°C and -80°C). Our forced degradation studies encompass stress testing under acid or alkaline conditions, oxidative stress testing and photostability studies. Based on the innovator’s specific needs, we can develop and tailor stability studies, as well as forced degradation tests, at any stage of the drug development.