Assay (HPLC): ≥ 98.0%
Appearance: White to pale yellow crystalline powder.
Identification (IR): Passes test.
Identification (UV): Passes test.
Melting Range: 160-163°C.
Loss on Drying: ≤ 0.5% (at 105°C for 2 hours).
Residue on Ignition: ≤ 0.1%.
Heavy Metals (as Pb): ≤ 10 ppm.
Related Substances (HPLC): Total impurities ≤ 1.0%, individual impurity ≤ 0.5%.
Solubility (1% in ethanol): Clear, colorless to pale yellow solution.
Specific Rotation: [α]²⁰D = +425° to +435° (c=1 in ethanol).
Chromatographic Purity (TLC): Single spot.