(lye' doe kane hye'' droe klor' ide).
Acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate;
2-(Diethylamino)-2',6'-acetoxylidide monohydrochloride monohydrate [6108-05-0].
Anhydrous 270.80 [73-78-9].
Lidocaine Hydrochloride contains NLT 97.5% and NMT 102.5% of C14H22N2O·HCl, calculated on the anhydrous basis.
• A. Infrared Absorption 197K
Standard: Prepare as directed in 197K, using USP Lidocaine RS.
Sample: Dissolve 300 mg in 510 mL of water in a separator, add 4 mL of 6 N ammonium hydroxide, and extract with four 15-mL portions of chloroform. Combine the chloroform extracts, evaporate with the aid of a current of warm air, and dry the residue in vacuum over silica gel for 24 h.
Acceptance criteria: Meets the requirements
• B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
• C. Identification TestsGeneral, Chloride 191: Meets the requirements
Solution A: Water and glacial acetic acid (930:50). Adjust with 1 N sodium hydroxide to a pH of 3.40.
Mobile phase: Acetonitrile and Solution A (1:4), so that the retention time of lidocaine is 46 min
Standard solution: Dissolve 85 mg of USP Lidocaine RS, with warming if necessary, in 0.5 mL of 1 N hydrochloric acid in a 50-mL volumetric flask. Dilute with Mobile phase to volume (1.7 mg/mL of lidocaine).
System suitability stock solution: 220 µg/mL of methylparaben in Mobile phase
System suitability solution: Mix 2 mL of System suitability stock solution and 20 mL of Standard solution.
Sample solution: 2 mg/mL of Lidocaine Hydrochloride in Mobile phase
Detector: UV 254 nm
Column: 3.9-mm × 30-cm; packing L1
Flow rate: 1.5 mL/min
Injection size: 20 µL
Samples: Standard solution and System suitability solution
Resolution: NLT 3.0 between lidocaine and methylparaben, System suitability solution
Relative standard deviation: NMT 1.5%, Standard solution
Samples: Standard solution and Sample solution
Calculate the percentage of C14H22N2O·HCl in the portion of Lidocaine Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
Acceptance criteria: 97.5%102.5% on the anhydrous basis
• Residue on Ignition 281: NMT 0.1%
• Chloride and Sulfate, Sulfate 221: Dissolve 100 mg in 10 mL of water, and add 1 mL of 3 N hydrochloric acid. Mix, and add 1 mL of barium chloride TS. The turbidity does not exceed that produced by 0.10 mL of 0.020 N sulfuric acid (NMT 0.1%).
• Heavy Metals, Method I 231: 20 ppm
• Melting Range or Temperature 741: 7479
[NoteThe preliminary drying treatment is omitted. ]
• Water Determination, Method I 921: 5.0%7.0%
• Sterility Tests 71: Where the label states that Lidocaine Hydrochloride is sterile, it meets the requirements.
• Bacterial Endotoxins Test 85: Where the label states that Lidocaine Hydrochloride is sterile or must be subjected to further processing during the preparation of injectable dosage forms, it contains NMT 1.1 USP Endotoxin Units/mg of lidocaine hydrochloride.
• Packaging and Storage: Preserve in well-closed containers. Store at room temperature.
• Labeling: Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
• USP Reference Standards 11
USP Endotoxin RS
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USP35NF30 Page 3683Pharmacopeial Forum: Volume No. 36(5) Page 1191