Recombumin Prime - Recombinant Human Albumin

Recombinant DNA expression in Saccharomyces cerevisiae produces d Recombinant Albumin Human (rAlbumin Human or rHA). Structural equivalence (primary, secondary, and tertiary) between human serum albumin (HSA) and rHA has been shown.

Product Specifications

Characteristics Analytical method USP-NF requirements Albumedix specification
Identification – Peptide Mapping USP-NF The peptide map chromatographic profiles of the Sample solution are similar to those of the Standard solution Chromatographic profiles of Test Solution are similar to those of the Standard Solution
Identification- Electrosprey Mass Spectrometry USP-NF Theoretical Mass ± 20 Da (66418 to 66458) Theoretical Mass ± 20 Da (66418 to 66458)
Bacterial Endotoxins USP <85> ≤ 0.5 USP Endotoxin Unit/mL of rAlbumin Human ≤ 0.5 USP Endotoxin Unit/mL of rAlbumin Human
Sterility USP <71> Meets the requirements of the test Meets the requirements of the test
pH (1%w/v) USP <791> 6.4 – 7.4 6.7 – 7.3
Impurities – High Molecular Weight Proteins USP-NF ≤ 1.0% ≤ 1.0%
Assay – Albumin Content (Purity) USP-NF (Native Page) ≥ 99.0% ≥ 99.0%
Assay – Total Protein USP-NF 19.0 – 21.0 %w/v 19.0 – 21.0 %w/v
Sodium USP-NF 120 – 160 mM 130 – 160 mM
Appearance Visual Inspection Aqueous liquid preserved in tight glass containers 50 mL glass vial, free from defects, with grey stopper and metal and plastic overseal, containing slightly viscous clear straw to amber coloured solution practically free from visible contamination
Impurities – Host Cell Protein In-House (Yeast Antigen ELISA) ≤ 0.15 µg/g ≤ 0.15 µg/g
Con A-binding rHA In-house Not specified for rAlbumin Human ≤ 0.30% (w/w) protein
Nickel In-house Not specified for rAlbumin Human ≤ 0.5 µg/g protein
Potassium In-house Not specified for rAlbumin Human ≤ 0.01 mmol/g protein
DBA leachates In-house Not specified for rAlbumin Human Dye Fragment (DAAS) ≤ 0.1 µg/g protein
Dye Base ≤ 0.1 µg/g protein
Dye + Spacer ≤ 0.4 µg/g protein
PBA leachates In-house Not specified for rAlbumin Human ≤ 0.18 µg/g protein
Octanoate In-house (GC) Not specified for rAlbumin Human 28.8 – 35.2 mM
Polysorbate 80 In-House (GPC) Not specified for rAlbumin Human 10-20 mg/L