Human Serum Albumin 20%, 25%

Example Specifications 1

Product description

Human Serum Albumin, 20%, 25% liquid

Starting Material

Normal Human Serum/Plasma
Starting materials have been single donation tested by FDA approved test methods, and found non-reactive for HBsAg, and negative for anti-HIV 1+2 and anti-HCV. HIV-1 RNA and HCV RNA tested (on pool) and found non-reactive.

Catalogue Code

A0101

Volume

10 – 50 kg in 50 – 100 ml bottles

Appearance

Liquid

Storage

Room temperature

Protein Composition

98.4%

Total Protein

20.2%

Potassium

< 0.5 mEq/L

Sodium

140 mEq/L

pH

7.1

Example Specifications 2

Product description

Human Serum Albumin, 20% liquid

Starting Material

Normal Human Serum/Plasma
Starting materials have been single donation tested by FDA approved/CE marked Test methods, and found non-reactive for HBsAg, and negative for anti-HIV 1+2, anti-HCV and STS. HIV-1 RNA, HAV RNA, HBV DNA, and HCV RNA tested (on pool) and found non-reactive. The B19V DNA (NAT) titer of the plasma pool is <=104 IU/ml.

Catalogue Code

A0102

Volume

200kg in 100ml bottles

Appearance

Liquid

Storage

+2°C ~ +25°C

Analyses Results Unit Specification
Albumin 97 % ≥ 96 (≥96% prin.band/≤4% asso.prot)
Protein 204 mg/ml 190-210
Non-protein nitrogen 0.4 mg/ml ≤ 0.7
Potassium 0 mg/ml ≤ 0.08
Chloride 2.48 mg/ml ≤ 3.55
N-accetyl-dl-tryptophan 4 mg/ml 3.5-4.3
Osmolality 230 mOsmol/kg 210-260
Haem 0.04 Haem ≤ 0.15
Prekallikrein activator <3 IU/ml ≤ 35
pH 6.9 6.7-7.3
Aluminium <20 µg/l ≤ 200
Sodium caprylate 2.8 mg/ml 2.4-3.1
Polymers and aggregates 6 % ≤ 10
Sodium 2.9 mg/ml 2.7-3.0
Endotoxin concentration <0.5 IU/ml <1.3

This product is for further manufacturing or research and development use only. Neither product reliability after removal from original container and/or treatment of product whatsoever, nor any responsibility for misuse of product can be granted. Post market surveillance and vigilance is the receiver's duty only.

Specifications are customizable. Vial fill size, form, concentrations, markers, volume and number of levels.