Liposome Characterisation and Analysis for Drug Delivery
Products & Services
Information
The regulatory expectations for a liposomal drug product specification include a range of parameters including analysis of all components of the drug product such as the lipids, the free drug, encapsulated drug and process impurities. Our liposome team provide analytics to help you address the following:
Physicochemical parameters determined to be CQAs (e.g. particle size, size distribution, zeta-potential and physical stability)
Liposome contained and free drug substance
Total drug substance content, as labelled
Degradation products related to the lipids (e.g. lysolipids) or drug substance
Lipid content (to demonstrate consistency with the intended formulation)
Residual solvent(s), if any organic solvent(s) are used in the manufacture of the liposome product
In vitro release of drug substance from the liposome drug products
https://www.intertek.com/pharmaceutical/gmp-cmc-laboratory/liposome-drug-product-characterisation/
