Properties | Method | Range | Units |
---|---|---|---|
Bacteria and Fungi/Sterility | EP 2.6.1, USP <71>, 21CFR610.12 | Not Detected | N/A |
Biochemical Profile | Chemistry Analyzer, photometric | As Reported | Various |
Electrophoretic Pattern | Cellulose Acetate | Characteristic | N/A |
Endotoxin | USP <85>, EP 2.6.14 | <10 | EU/mL or IU/mL |
Hemoglobin | Three-Wavelength Polychromatic | <30 | mg/dL |
Immunoglobulin (IgG) | ELISA | Various | ug/mL |
Mycoplasma | Barile, MF and Kern J (1971) | Not Detected | N/A |
Osmolality | USP <785> | Various | mOsm/kg |
pH | USP <791> | Various | N/A |
Protein-Total | Biuret | Various | g/dL |
Virus Testing | 9 CFR 13.53, 113.46 and 113.47 | Tested | N/A |
Virus Testing - | 9 CFR 113.43 | Not Detected | N/A |
Cytopathic Agents | |||
Virus Testing - Hemadsorbing | 9CFR 113.46 | Not Detected | N/A |
Virus Testing- | 9CFR113.215, company specific | As Reported | N/A |
Serum Neutralization |
Properties | Method | Range | Units |
---|---|---|---|
Performance - Growth Promotion | Cell grown in culture | 75% growth to control | N/A |
Performance - Cloning | Cells grown in culture | 75% growth to control | N/A |
Serum Species Identification | Ouchterlony double immunodiffusion | Positive for Bovine, Negative for Equine and Porcine | N/A |