Liposomal Drug Delivery Technologies Development Support and Analysis

Liposomal Drug Delivery Technologies Development Support and Analysis
Product Description

Liposomal drug product characterisation according to the FDA CMC guidance to support your new drug application or biologics license applications. Including: 

  • 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
Find out more: 

www.intertek.com/pharmaceutical/gmp-cmc-laboratory/liposome-drug-product-characterisation

Intertek Pharmaceutical Services

  • GB
  • 2015
    On CPhI since
  • 4
    Certificates
Consultancy
Contract Service
Manufacturer/Innovator
Specifications
  • Supplied from
    United Kingdom

Intertek Pharmaceutical Services

  • GB
  • 2015
    On CPhI since
  • 4
    Certificates
Consultancy
Contract Service
Manufacturer/Innovator

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