Product Quality
More than 20 years of experience, R&D project expertise and investment have been necessary to offer a unique product quality on the market. The initial process developed by Belovo has been optimized since 2012 in order to offer a very high-quality product according to the highest market standards.
What does a concentration of 2 gr per liter of avidin mean? Not very much, if the 3 criteria of quality are not defined.
- 1/ Specific activity: better specific activity means less avidin for the same effect. The specific activity of pure avidine at e-Proteins is > 99%.
- 2/ Purity in proteins. Better purity means fewer regulatory affairs. The purity of the protein is superior than 99%.
- 3/ Remaining Salt: to control the buffers in the in the drug substance is an advantage which simplifies the work of regulatory affairs.
Specifications
| In liquid | In powder | |
|---|---|---|
| Character | Clear an colourless | Clear an colourless |
| Identity | Clear an colourless | Clear an colourless |
| Purity (including natural dimer) | >=99% | >=99% |
| Biological activity | >14,5 U/mg | >14,5 U/mg |
| Electrophoretic | complies | complies |
| Aggregation (dimer) | <= 5% | <= 5% |
| Total Proteins (in liquid) | 2-5 mg/mL | N/A |
| Moisture | N/A | <=5% |
| pH | 6,8-7,2 | 6,8-7,2 |
| Material Endotoxin | <1 EU/mL | <1 EU/mL |
| Micro biological | <1 EU/mL | <1 EU/mL |
| Packaging in 5,20, 50ml | OK | N/A |
| Packging 1 gr , 10 gr , 100 gr | N/A | Ok |