C15H22N2O·HCl 282.81

2-Piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-methyl-, monohydrochloride, (±)-.
(±)-1-Methyl-2¢,6¢-pipecoloxylidide monohydrochloride [1722-62-9].

Packaging and storage— Preserve in well-closed containers.

USP Reference standards 11— USP Mepivacaine Hydrochloride RS.

Identification—

Loss on drying 731— Dry it at 105 for 4 hours: it loses not more than 1.0% of its weight.

Residue on ignition 281: not more than 0.1%.

Chromatographic purity— Mix about 500 mg with 10 mL of water to obtain a test solution. Inject about 1 µL of this solution into a suitable gas chromatograph (see Chromatography 621), equipped with a flame-ionization detector. Under typical conditions, the instrument contains a 1.8-m × 4-mm glass column packed with 3 percent phase G19 on packing S1A. The column is maintained at about 230, and dry helium, flowing at the rate of about 40 mL per minute, is used as the carrier gas. Similarly inject about 1 µL of a Standard solution of USP Mepivacaine Hydrochloride RS in water having a concentration of about 5 mg per mL. Locate the mepivacaine peak in each chromatogram. The total area of all extraneous peaks (except that of the solvent peak) recorded for the test solution, over a time span of not less than 1.3 × the retention time for mepivacaine, relative to the total area of all peaks does not exceed 0.4%.

Residual solvents 467: meets the requirements.

Assay— Transfer about 550 mg of Mepivacaine Hydrochloride, accurately weighed, to a 200-mL beaker, and dissolve in 50 mL of glacial acetic acid, heating if necessary. Add 10 mL of mercuric acetate TS and 1 drop of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 28.28 mg of C15H22N2O·HCl.

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP29–NF24 Page 1343

Phone Number : 1-301-816-8143