Starting Material
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, anti-HCV, Syphilis. HIV-1 RNA, HBV DNA, HCV RNA tested (on pool) and found non-reactive.
Catalogue Code
A1950
Volume
100g – 10kg
Physical Appearance
Pink to Reddish Crystalline Powder Lyophilised from 0.020M NH4HC03 solution. May contain traces of buffer salts.
Heat inactivation
10 hours at 62°C ± 2°C
Protein Content
≥98% calculated from Nitrogen elemental analysis value using a protein factor of 6.49
Storage
Refrigerated at +2 - +8 ° C
| Analytes | Specification | Results |
|---|---|---|
| Nitrogen | 15.77% [dried for 3 hours under vacuum at 60°C] | |
| Endotoxin | ≤ 1 EU/mg | < 0.05 EU/mg by LAL assay |
| Bioburden | < 10 CFU/ml | Pass |
| Mycoplasma | Negative | |
| Estimated Iron | 1100-1600 ppm | 1241 ppm by ICP |
| Moisture | ≤ 5% | 1.48% by loss of drying |
| Moisture | ≤ 5% | 1.54% by Karl Fisher |
| Solubility | Readily soluble at 1 % in de-ionised water | |
| pH [3% solution] | 6.5 - 8.0 | 7.01 |
| OD at 280nm [10mg/ml in water] | 12.50 |
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.
