Recombumin Elite - Recombinant Human Albumin

Recombinant DNA expression in Saccharomyces cerevisiae produces Albumedix™ Recombumin® Elite.

Product Specifications

Characteristics Analytical method Albumedix specification
Appearance Visual Inspection Clear, pale straw/amber colored solution
Assay – Albumin Content (Purity) USP-NF (Native PAGE) ≥ 99.0%
Assay – Total Protein USP-NF (Kjeldahl) ≥ 95 g.L-1
Sodium USP-NF (AA) 200 – 300 mM
Impurities – Host Cell Proteins In-house (Yeast Antigen ELISA) For Information Only (ng/g rAlbumin Human)
pH (1% w/v) USP <791> 6.0 – 7.0
Bacterial Endotoxins USP <85> ≤ 0.01 EU/mg of rAlbumin Human
Mass Analysis USP-NF Theoretical Mass ± 20 Da (66418 to 66458)
Impurities – High Molecular Weight Proteins USP-NF ≤ 1.0% (w/w) rHA
Octanoate In-house (GC) ≤ 1 mM
Bioburden In-house (Membrane Filtration) ≤ 10 cfu/mL