By utilising the resources and expertise we have developed as a product manufacturer, we are able to provide certain functions in the supply chain as stand-alone services
The services we offer include routine laboratory analysis and the compiling of Common Technical Documents (CTDs).
Our in-house laboratories are managed according to GLP principles, allowing us to offer routine analysis on an ongoing basis for our clients. Our laboratory capabilities include:
General chemistry laboratory
- FT/IR identification
- Viscosity, pH, Conductivity, Specific gravity
- Loss on drying, dissolution, solubility
- Tablet and capsule disintegration
- High-performance liquid chromatography
- Thin layer chromatography and fingerprinting
- Gas chromatography
Stability room (Shelf life testing)
- Long term stability chambers
- Short term stability chambers
- Total plate count
- Yeast and moulds
- E.coli (quantitative analyses)
- Salmonella (quantitative analyses)
- Bile-tolerance estimations
Since the Medicines and Related Substances Act has been amended, making provision for Category D (CAMS) medicines to be registered, Afriplex has been assisting clients with dossier compilation.
Our capability to generate the applicable data on active ingredients, to conduct method and process validations and to develop and execute the required stability programs are now accepted as a reliable service to the CAMS industry.