Albumin

Category

Stabilizer; Therapeutic Agents

Grade

Pharmceutical Excipients

Chemical Name

Serum albumin

CAS Number

9048-49-1

Administration route

Intravenous

Dosage Form

Intravenous injection

Stability and Storage Conditions

Albumin is a protein and is therefore prone to chemical degradation and denaturation under extreme pH conditions, high salt concentrations, heat, enzymes, organic solvents and other chemical agents present. Albumin solution should be stored away from light at 2 ~ 25 ° C, or according to label instructions.

Source and Preparation

Human blood albumin is a sterile, pyrogen free serum albumin product obtained from a healthy donor's isolate (source blood, plasma, serum or placenta); The source material must not be tested to contain hepatitis B surface antigen. The production process should ensure that the product is safe and can be used for intravenous injection.

Applications

Albumin is mainly used as an excipient in the prescription of injectable drugs, as a stabilizer for proteins and enzymes in the prescription. Albumin is also used in the preparation of microspheres and microcapsules in experimental drug delivery systems. As a stabilizer, albumin is used in protein prescriptions at a low concentration of 0.003%. However, concentrations of 1.to 5% are usually used. Albumin is also used as a co-solvent for injecting drugs and as an antifreeze during the freeze-drying process to prevent the surface from adsorbing other proteins. Therapeutically, albumin solutions have been used for injection to replenish plasma volume and treat severe acute albumin loss.