Appearance | Milky turbid suspension, free from impurities (foreign particles) |
Microscopic evaluation | Uniform spherical particles, no agglomerates, no fines |
Extractable matter (water) | ≤ 0.05 % |
Cerium | ≤ 10 µg/g |
Pressure drop (column: ID=1.6 cm, L=10 cm at 5 ml/min) | ≤ 1.0 bar |
Particle size (d10) | 37 - 45 µm |
Particle size (d50) | 48 - 60 µm |
Particle size (d90) | 63 - 77 µm |
TAMC (total aerobic microbial count) | ≤ 20 CFU/ml |
TYMC (total yeast and mould count) | ≤ 20 CFU/ml |
Endotoxins | ≤ 1.00 EU/ml |
Protein binding capacity (lysozyme) | 70 - 105 mg/ml |
Ionic Capacity | 95 - 145 µeq/ml |
Functional test (b:a) | ≤ 0.30 |
Functional test (c:d) | ≤ 0.70 |
Conductivity: Chymotrypsinogen A | |
Conductivity: Cytochrom C | |
Conductivity: Lysozyme | |
Functional test: Separation of chymotrypsinogen A, cytochrome C and lysozyme |