BRIEFING

 Mannose. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analyses is proposed. The proposed liquid chromatographic (LC) procedure used in the Chromatographic Identity, Assay, and Related Substances tests is based on the analyses performed with the BIO-RAD brand of Aminex HPX-87C column with L19 packing. The typical retention times for glucose, mannose, and fructose are about 19.8, 22.8, and 25.1 min, respectively.

 (SE: G. Holloway)

 Correspondence Number—C315716