Human albumin solutions from a number of manufacturers are received for batch release testing at NIBSC. Such tests include the assay of pre-kallikrein activator (PKA), SE-HPLC for polymers and aggregates, and a visual inspection for particulate contamination.
| Product | Release test(s) including whether PhEur/WHO or in house |
|---|---|
| Albumin |
SE-HPLC for molecular size distribution (PhEur method) |
| Appearance - visual inspection for particles (PhEur method) | |
| PKA assay (PhEur method) |
| Code | Description |
|---|---|
| 02/168 | 2nd International Standard for PKA |
|
00/488 |
PKA control Used in the PKA assay |