| TEST |
METHOD |
SPECIFICATION |
| Cytotoxicity |
Cell Culture |
Non-toxic |
| Endotoxin |
LAL gel clot |
< 0.5 EU/mL |
| Hemoglobin |
Spectrophometer |
< 20 mg/dL |
| Identity |
Electrophoresis |
Normal |
| Mycoplasma |
PCR |
Not detected |
| pH |
pH meter |
6.9 - 7.8 |
| Osmolality |
Vapor Pressure |
280-340 mOsm/Kg water |
| Sterility |
Modified 21CFR610.12 |
No growth |
| Total Protein |
BCA |
Pass |
| USDA Import |
Virus testing (e.g., Bluetongue) |
Not detected |
PERFORMANCE TESTING |
| BHK-21 |
Cell Culture |
Pass* |
| COS-7 |
Cell Culture |
Pass* |
| HeLa |
Cell Culture |
Pass* |
| L-929 |
Cell Culture |
Pass* |
| SF-9 |
Cell Culture |
Pass* |
| |
|
* > 85% of FBS control lot |
| |
|
