API sourcing and characterization from Delim

A constant issue for the pharmaceutical industries is to find API suppliers that are compliant with current and emerging regulations. Further challenges are to be able to characterize API’s from the supplier to apply tailor-made particle engineering and size distribution optimization for enhanced performance through processes like spray-drying.

Delim Cosmetics & Pharma’s suite of highly advanced B2B services for the development of innovative, generic and bioequivalent pharmaceutical products meet these needs with tailored solutions for API sourcing and characterization.

Leading edge methods

These use leading-edge reverse phase high performance liquid chromatography (RP-HPLC) technology for API characterization, with ability to set-up and develop custom methods for Assay and related substances determination. Delim’s laboratories use Design of Experiment (DoE) and Quality by Design (QbD) methodologies to obtain the desired final API particle size distribution.

Delim also works in collaboration with Univeristà degli Studi di Milano and its experts to offer a complete list of API characterization services that employ advanced technologies like XRPD (X-Ray Powder Diffraction), GC (Gas Chromatography), DSC (Differential Scanning Calorimetry) and TGA (Thermogravimetric analysis), SEM (Scanning Electron Microscope), etc.

Eliminating uncertainty

A recent article by Jonathan Knight, Director of Market Intelligence and New Technologies at Cambrex that summarizes factors to be considered when choosing an API supplier (see Resources) remarks that the advent of new manufacturing centers has increased uncertainty.

“Most generics are available from many potential API suppliers (up to 25 in some instances), particularly from India, so where does a would-be customer start?” he asks.

“For innovator companies, due diligence is the most important step they can take when looking to ensure reliable supply. The alternative situation can lead to problems, excessive time and money being spent to solve them, and additional expense to find a replacement,” say Mr. Knight.

Delim provides an end-to-end solution for supplier diligence by combining market knowledge with scientific expertise.

Resources

Click on API sourcing: what to look for in a supplier for background information.
Click on API Characterization for technical information.
Click on Delim Pharmaceutical Services to learn more.