Description
A white of light yellow a morphous powder, amorphous solid

Identification
Complies with EP

Appearance of Solution
Slottion S is clear and not more intensely coloured than reference solution Y6

Resudual Solvents
NMT 1.0% of acetone, 0.5% of methanol, and 0.4% of mesityl oxide

Water
NMT 2.0%

pH
6.5 and 7.5, in a solution (1 in 100)

Heavy Metal
NMT 20 ppm, pb : NMT 10ppm

Assay
98.0 to 101.5%

Related Substances
Individual impurity NMT 0.5% Sum of impurity : NMT 1.0%

Specific Rotation
Between +41.5˚and +44.5˚, on the anhydrous and solvent-free basis

Bacterial Endotoxin
Less than 0.17 IU/mg

Packaging and Storage
Preserve in containers for sterile solids and store in an air tight container, at a temperature not exceeding 8℃