Identification
The infrared absorption spectrum of a potassium bromide dispersion of the sample, previously dried in vacuum at 60° for 5h, exhibits maxima only at the same wavelengths as those of a similar preparation of USP Levocarntiine Reference Standard.
AssayNot less than 97.0% and not more than 103.0% of C7H15NO3, calculated on the anhydrous basis.
Chloride Not more than 0.4%.
Lead Not more than 1mg/kg.
Loss on Drying Not more than 1.0%.
Optical (Specific) Rotation [α]20°D:Between -29.0°and -32.0°, calculated on the anhydrous basis.
pHBetween 5.5 and 9.5, in a 1:20 aqueous solution.
Potassium Not more than 0.2%.
Residue on Ignition Not more than 0.2%.
Sodium Not more than 0.1%.
Water Not more than 4.0%.
