Packaging and storage— Preserve in tight containers.

USP Reference standards 11— USP Lidocaine RS.

Identification— Place in a separator containing 10 to 15 mL of water a quantity of Jelly, equivalent to about 300 mg of lidocaine hydrochloride, mix to assure thorough dilution of the Jelly, add 4 mL of 6 N ammonium hydroxide, and extract with four 15-mL portions of chloroform. Combine the chloroform extracts, and evaporate with the aid of a current of warm air to dryness. Redissolve the crystals in solvent hexane, evaporate with the aid of warm air, and dry the residue in vacuum over silica gel for 24 hours: the lidocaine so obtained responds to Identification test A under Lidocaine.

Sterility 71: meets the requirements.

Minimum fill 755: meets the requirements.

pH 791: between 6.0 and 7.0.

Residual solvents 467: meets the requirements.

Assay— Accurately weigh into a separator containing 10 to 15 mL of water a quantity of Jelly, equivalent to 20 to 30 mg of lidocaine hydrochloride, mix to assure thorough dilution of the Jelly, add 1 mL of 6 N ammonium hydroxide, and extract by shaking with four 20-mL portions of chloroform. Combine the chloroform extracts, and evaporate with the aid of a current of warm air, adding 25.0 mL of 0.01 N sulfuric acid VS just before the last trace of chloroform is expelled. Complete the evaporation of the chloroform, and titrate the excess acid with 0.01 N sodium hydroxide VS, determining the endpoint potentiometrically (see Residual Titrations under Titrimetry 541). Each mL of 0.01 N sulfuric acid is equivalent to 2.708 mg of C14H22N2O·HCl.

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

USP29–NF24 Page 1253

Phone Number : 1-301-816-8143