| Quality Tests |
IP 2014 of rabies vaccine |
TCALRV-B |
| Sterility test |
Negative (-) |
Negative (-) |
| Residual Serum Albumin |
≤ 50 ng/dose |
16 ng/dose |
| Residual BPL |
Not more than 1:3500 |
Below the level |
| Potency |
≥ 2.5 IU/dose |
≥ 3.1 IU/dose |
| Residual Vero cell DNA |
≤100 pg/dose |
10 pg/dose |
| Bacterial Endotoxin |
≤ 50 EU/dose |
≤ 50 EU/dose |
| Protein content |
≤ 80 μg/dose |
65 μg/dose |
| pH |
7.2-8.0 |
7.8 |
| Abnormal Toxicity |
Passed |
Passed |
| Avirulence Test |
Negative |
Negative |
| Virus Amplification Test |
Negative |
Negative |
|
