API impurities and degradation products

API impurities and degradation products

Purification and identification by cryoprobe NMR

The safety of a drug is impacted by it’s susceptibility to form degradation products, and the existence of any impurities introduced during the manufacturing process. To meet regulatory guidelines, significant degradation products or impurities must be identified. This involves isolation and definitive structure elucidation of the degradant or impurity, typically by NMR spectroscopy. Purified amounts of impurities may be required for use as analytical standards, or for safety assessments.

Hypha scientists are adept at purifying small amounts of impurities, metabolites and degradation products from complex matrices in which they form the minor component.

Definitive identification of the structures is performed by interpretation of NMR spectra acquired using a 700 MHz machine equipped with a 1.7 mm cryoprobe. Only small amounts of purified material are needed e.g. ~100 micrograms. Purifications can be scaled to provide more material.

Further amounts of oxidized degradation products of the API can be made using Hypha’s chemical synthesis and biotransformation methods. This involves screening the drug against a panel of conditions to identify a suitable method for scale-up.