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