Generic method approach for determination of residual solvents in active pharmaceutical ingredients by gas chromatography
Solvents are defined as organic chemicals that are used to dissolve components; they are used during the manufacture of drug substances. Solvents can also potentially be formed as by-products of the synthetic process. Depending on their structure, solvents have varying degrees of toxicity. Upon completion of the synthetic process, an objective is to remove completely or reduce the residual levels of these solvents to points at which they pose no risk to patient safety in the final formulated drug product.
View Resource
Almac API, Chemical Development, Analytical & Solid State Services
Almac Sciences provides integrated services from development to commercial scale of advanced intermediates and Active Pharmaceutical Ingredients (API).
We provide a range of services for small molecules (including highly potent) and peptides. We have a proven track record of saving time and cost through the integration of our services and application of innovative biocatalysis and technology solutions.
We offer a full suite of analytical testing for a range of different product types including small molecules, peptides, biologics, conjugates, potent and controlled substances.
Our vast pool of scientific knowledge can help to overcome the analytical challenges that typically arise during drug development.