Exact And Easy Analysis Of Hyaluronic Acid By HPAEC PAD For Purity And Content

By Novozymes Biopharma US Inc.

The increasing use of hyaluronic acid (HA) in pharmaceutical and medical applications, brings about an ever increasing focus on safety. This requires that new analytical methods for HA analysis are employed in addition to those offered by the regulatory literature such as the European Pharmacopoeia [1] for purity and content.

Novozymes produces HA from Bacillus subtilis [2]. This bacillus HA has been awarded a GRAS (Generally Recognized As Safe) designation. Bacillusis free of endotoxins and exotoxins and is without difficulty controlled during fermentation. Through a specially developed recovery method, the organism is easily removed from the HA in a purely water based recovery process. The HA produced is of a high purity, to establish this high purity, new analytical methods have been developed.