Ashland has been actively included in the evolution of USP-NF monographs
Ashland, a primary specialty materials enterprise, has declared obedience with the approaching Lactide (or lactic acid) and Glycolide (or glycolic acid) (LG) polymer USP-NF monographs.
The release got in the course of a joint webinar with Ashland and Oakwood laboratories on scale-up of long performing injectables. Ashland has been actively included in the evolution of USP-NF monographs, preferred chapters and reference standards for LG Polymers. Patrick Duffy, PhD, R&D team chief, Ashland, works as an professional consultant to USP’s joint sub-committee working on LG polymer monographs.
The USP–NF connects America Pharmacopeia (USP) and the National Formulary (NF) and holds more than 5,000 public quality requirements for chemical and biologic medicines, active pharmaceutical ingredients (APIs), dietary ingredients and dietary supplements, and excipients. It also keeps standards for diverse analytical testing out techniques, medicine storage and distribution, compounded medicines, prescription labeling and plenty of different factors of medical product evolution, manufacture and use.
Regulatory assessment of LG polymer-holding drug products remains hard because of the complexities of LG polymers, their characterization and testing out, and use in formulations. The USP advanced a suite of solutions to assist formulators meet the regulatory expectations and characterization challenges related to these polymers. This works contains the evolution of a series of NF monographs – that are used to articulate the quality expectations for a medicine. Expectations are included for a drug’s identification, strength, purity, and performance. Monographs additionally describe tests required to validate the medicine and its ingredients meet anticipated criteria.
The first three LG polymer monographs have now been published in USP-NF 2025, Issue 1 and will be official as of May 1, 2025.
• DL-Lactide and Glycolide (50:50) Copolymer 12000 Acid
• DL-Lactide and Glycolide (50:50) Copolymer 12000 Ethyl Ester
• DL-Lactide and Glycolide (50:50) Copolymer 46000 Acid
Ashland has completed verification testing out of corresponding grades from the vital portfolio of LG polymers on the way to certify compliance with those lately published NF monographs. Today, the enterprise declared its vital portfolio of products meet the stringent first-rate requirements related to the upcoming monographs.
