Degussa shortens time to API purity
which reduces the time it takes manufacturers to remove unwanted
transition metals from active pharmaceutical ingredients (APIs), by
eliminating the filtration step.
Until now, to remove unwanted metals from an API product, metal scavengers were added to batch-mode reactors and stirred in with the product, a process that then requires a filtration step.
>Degussa's unique flow distributor, supplied in the form of a cartridge, allows the API solution with the metal contaminate to be transferred directly through the column, where the metal is removed by metal scavengers in what the company terms as "fixed-bed mode."
The new filter is used in conjunction with Degussa's recently relaunched metal scavengers, Deloxan THP II or Deloxan MP, which both carry different functional groups for performance under varying experimental conditions.
The company has begun to focus marketing attention on its metal scavenger and filtration products due what it has identified as an increased demand in the market.
This demand is being driven by homogenous catalysts, which are increasingly being used in pharmaceutical synthesis, as they are enabling new synthetic routes to be carried out on a commercial scale.
The process of homogenous catalysis, however, introduces metal impurities into the final product, and these need to be removed as part of the quality control process.
"An API must have less than 1 ppm metal contamination," Jonas Ide, product manager, pharma polymers, told In-PharmaTechnologist.com.
The company claims that the surface density of its metal scavengers is significantly higher than that of surface-modified or post-reacted polymers that are on the market, allowing more metals to be captured.
"An additional unique feature of our metal scavenger polymers is that they are bead-shaped, allowing for faster filtration and less pressure drop in the column when using the fixed-bed mode," said Ide.
"This gives our polymers distinct advantages over polymers developed by competitors such as Johnson Matthey, who use fibres and Englehardt, who use powder forms of metal scavengers," he said.
The product will be available commercially by the end of the year and is already preliminarily being used by two US manufacturers, the company said.
