Table 3. Quality of SPEEDA PVRV according to the national standard of rabies vaccine for human use.
| Items | National standard of rabies vaccine for human use | SPEEDA ® PVRV |
|---|---|---|
| Sterility test Residual bovine serum albumin Potency test |
Negative (-) ≤ 50 ng/dose ≥ 2.5 IU/dose |
Negative (-) ≤ 50 ng/dose ≥ 4.5 IU/dose |
| Residual Vero cell DNA |
≤ 100 pg/dose |
≤ 100 pg/dose |
| Bacterial endotoxin |
≤ 50 EU/dose |
≤ 50 EU/dose |
| Total protein |
≤ 80 μg/dose |
≤ 80 μg/dose |
| Host protein |
≤ 4 μg/dose |
≤ 4 μg/dose |
| Antibiotics |
≤ 50 ng/dose |
- |
| pH | 7.2–8.0 | 7.2–8.0 |