» Lidocaine Ointment is Lidocaine in a suitable hydrophilic ointment base. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of lidocaine (C14H22N2O).
Packaging and storage Preserve in tight containers.
USP Reference standards 11
Identification Stir a quantity of Ointment, equivalent to about 300 mg of lidocaine, with 20 mL of water, transfer to a separator, and extract with two 30-mL portions of solvent hexane. Wash the combined hexane extracts with 10 mL of water, evaporate with the aid of a current of warm air, and dry the residue in vacuum over silica gel for 24 hours: the crystalline precipitate so obtained responds to Identification test A under Lidocaine.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
Minimum fill 755: meets the requirements.
Assay Proceed with Ointment as directed in the Assay under Lidocaine Hydrochloride Jelly. Each mL of 0.01 N sulfuric acid is equivalent to 2.343 mg of C14H22N2O.
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USP35NF30 Page 3682