| Test parameter |
Acceptance criteria |
Observation comply/Not comply |
| Assay |
As per monograph |
comply |
| Uniformity of weight |
Individual weight ± 5% of target fill weight |
comply |
| pH |
4.5 to 9.0 |
comply |
| Particulate matter |
Vials should be essentially free from visible particulate matter. Sub-visible particulate matter: ≥ 10 μ: NMT 3000/vial ≥ 25 μ: NMT 300/vial |
comply |
Uniformity of dosage units
(By weight variation) |
Meets the requirement, (NMT ± 15.0%) |
comply |
| Sealing of vials |
No. defects should be observed. |
comply |
