IPQC Parameters | OME 001A | OME 001B | OME 002A | OME 002B | OME00 3A | OME 00 3B |
Diameter (mm) | 9.4 ± 0.05 | 9.42 ± 0.05 | 9.38 ± 0.05 | 9.3 ± 0.05 | 9.41 ± 0.06 | 9.48 ± 0.06 |
Thickness (mm) | 5.77 ± 0.11 | 5.78 ± 0.11 | 6.02 ± 0.10 | 6.0 ± 0.10 | 5.97 ± 0.11 | 5.90 ± 0.11 |
Friability (5) | 0.369 | 0.387 | 0.339 | 0.350 | 0.468 | 0.384 |
Hardness (N) | 69 | 70 | 67 | 73 | 68 | 72 |
Weight uniformity | 229.6 ± 10 | 231.3 ± 10 | 231.1 ± 10 | 231.9 ± 10 | 231.8 ± 10 | 231.7 ± 10 |
Assay (%) | 105.2 ± 1.1 | 104.5 ± 0.0 | 105.5 ± 0.1 | 105.9 ± 0.1 | 100.1 ± 0.3 | 100.1 ± 0.3 |