Seroalbumin Description

Each vial contains total protein 200 g/Lit, sodium caprylate 6.65 g/Lit, Na+ not more than 160 mmol/L, K+ not more than 2 mmol/L, aluminum <200 ug/L.
An aqueous solution of protein obtained from the plasma of healthy donors; the plasma is tested for the absence of hepatitis B surface antigen and antibodies against HIV-1 and HIV-2 and hepatitis C virus. It is prepared as a concentrated solution containing 15 to 25% of total protein or as an isotonic solution containing 3.5 to 5% of total protein; not less than 95% of the total protein is albumin. A suitable stabiliser, such as sodium octanoate or N-acetyltryptophan or a combination of the two, may be added but no antimicrobial preservative is added. It contains not more than 160 mmol of sodium per litre and not more than 200 micrograms of aluminium per litre. The solution is sterilized by filtration and distributed aseptically into containers which are sealed to prevent contamination and maintained at 59°C to 61°C for not less than 10 hours. Finally, the containers are incubated for not less than 14 days at 30°C to 32°C or for not less than 4 weeks at 20°C to 25° C and examined visually for signs of microbial contamination. It should be stored in a colourless glass container and protected from light. A clear, almost colourless, yellow, amber, or green slightly viscous liquid. A solution in sodium chloride 0.9% containing 1 % protein has a pH of 6. 7 to 7.3. The BP 2008 gives Albumin and Human Albumin as approved synonyms.