apimanufacturing

Research and Development

PCI Synthesis technical team works diligently to develop creative, economic and safer solutions to complex process chemistries

Our talented Research & Development team provides the expertise you require from process research through development to deliver your final API or custom chemistry project. Here is an example of the level of professionalism and support you can expect to receive when working with our talented staff.

CASE STUDY

  • During the development phase of an API that our team recently completed, the reagent normally used to activate a hydroxyl group in the literature was triflic anhydride.   Triflic anhydride is an expensive, very reactive reagent.  In addition to the high costs associated with making the product along with the volatily of the product, the side-products formed during the reaction were often difficult to separate from the product causing impurities in the final product.
  • In typical PCI Synthesis approach to make the project economically viable for both the customer and PCI Synthesis, our team evaluated numerous alternative reaction chemistries.
  • After an extensive review of the literature, PCI replaced triflic anhydride with another activating reagent called perfluorobutane sulfonyl fluoride (PBSF). PBSF is commercially available at reasonable pricing. The reagent has low water reactivity and is stable at room temperature, thus making it easy to handle. It also is soluble in common organic solvents.  This reagent was successfully used in our process under mild conditions giving PCI a safe, economically viable process for the plant and our customer.

This is just another example of how the PCI Synthesis technical team works diligently to develop creative, economically and safer solutions to complex process chemistries.  We welcome the opportunity to partner with you in developing your next chemistry!

Research & Development Overview
  • Process Research
    - Custom synthesis and synthetic route evaluation from g - kg for API’s or intermediates
  • Process Development
    - Custom synthesis from kg – metric tons.
    - cGMP manufacturing of pharmaceutical actives and intermediates for clinical trials.
  • 10 DMF’s filed; 4 already approved
  • Scaled up over 150 processes