Monosaccharide analysis is a requirement from ICH Q6B guidelines for lot release characterization of glycoproteins being developed as biopharmaceuticals. This assay provides evidence of the presence or absence of N and O-linked glycans, as well as the relative amounts of each monosaccharide present. When compared to prior lots, this data can provide insight into process variations and provide prof of consistency during the manufacturing process.
The method is reliable and easy to use:
- Release of monosaccharides from the glycoprotein by mild acid hydrolysis
- Fluorescent labeling of released monosaccharides with 2-AA
- Relative quantitative analysis of 2AA-labelled monosaccharides by HPLC or UHPLC
The LudgerTag Monosaccharide Analysis Kit contains reagents for the release and fluorescent labeling of monosaccharides found on glycoprotein biopharmaceuticals and standards.
Part Number: LT-MONO-96
Developed for the analysis of monosaccharides labeled with 2-AA using the LudgerTag Monosaccharide Labeling Kit. The LudgerSep uR2 UHPLC column contains particles with an endcapped octadecylsilane coating optimized for hydrophobic chromatography.
Dimensions: 2.1mm x 50mm
Part Number: LS-UR2-2.1x50
A quantitative mix of six monosaccharides:
glucosamine - galactosamine - galactose - mannose - glucose/dextrose - fucose
10 nmols of each monosaccharide per vial
CM-MONOMIX-10 - 1 vial
CM-MONOMIX-10X3 - 3 vials
The glycopeptide is comprised of an A2G2S2 glycan attached to the asparagine amino acid of a peptide with the sequence Lysine-Valine-Alanine-Asparagine-Lysine-Threonine (KVANKT).
Purity: >90% as determined by UHPLC
Monoisotopic mass: 2865.1763 [M+H]+
Amount: 10 micrograms
Part number: BQ-GPEP-A2G2S2-10U
Fetuin glycoproteins are purified from fetal calf serum. Fetuin exists in a variety of glycoforms containing bi-, tri-, and tetraantennary N-linked oligosaccharides with variable sialylation, as well as O-linked glycans.
4 vials of 50 µg each
Part Number: GCP-FET-50U-X4