Description
White to almost white crystalline powder

Identification
Complies with reference IR spectrum and HPLC chromatogram

Specific Rotation
-58˚ to -62˚ (C=1, MeOH at 20z)

Solubility
Freely soluble in methanol, chloroform and acetonitrile;insoluble in water

Melting Point
129 - 134℃

Related Substance (By HPLC)
Total
NMT 1.0%
Single
NMT 0.5%

Residual solvents
Chloroform
NMT 0.006%
Isopropanol
NMT 0.1%


Loss on drying
NMT 0.5%

Residue on ignitio
NMT 0.1%

Heavy metal
NMT 20ppm

Chloride
NMT 0.02%

Sulfates
NMT 0.02%

Fluorine
14.7 to 17.9%

Assay
98.5 to 101.5%