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%.