(ar' ti kane hye'' droe klor' ide).
2-Thiophenecarboxylic acid, 4-methyl-3-[[1-oxo-2-(propylamino)propyl]amino]-, methyl ester, monohydrochloride;
Methyl 4-methyl-3-[2-(propylamino)propionamido]-2-thiophenecarboxylate, monohydrochloride [23964-57-0].
Articaine Hydrochloride contains NLT 98.5% and NMT 101.0% of C13H20N2O3S·HCl, calculated on the dried basis.
• A. Infrared Absorption 197
Standard solution: 12 mg/mL of USP Articaine RS in methylene chloride. Transfer 20 µL of this solution onto a 300-mg disk.
Sample solution: Dissolve 100 mg of Articaine Hydrochloride in 5 mL of water. Add 3 mL of a saturated solution of sodium bicarbonate, and shake twice with 2 mL of methylene chloride. Combine the methylene chloride layers, dilute with methylene chloride to 5.0 mL, and dry over anhydrous sodium sulphate. Transfer 20 µL of this solution onto a 300-mg disk.
Sample solution: 250 mg of Articaine Hydrochloride to a 250-mL conical flask. Add 5.0 mL of 0.01 M hydrochloric acid and 50 mL of alcohol. Stir to dissolve.
Analysis: Titrate with 0.1 M sodium hydroxide VS, determining the endpoint potentiometrically, using a glass electrode. Calculate the volume of sodium hydroxide consumed by reading the volume added between the two points of inflection. Each mL of 0.1 M sodium hydroxide is equivalent to 32.08 mg of C13H20N2O3S·HCl.
Acceptance criteria: 98.5%101.0% on the dried basis.
• Heavy Metals, Method I 231
Sample solution: 200 mg/mL of Articaine Hydrochloride
Acceptance criteria: NMT 5 ppm
• Residue on Ignition 281
Sample: 1 g
Acceptance criteria: NMT 0.1%
Buffer solution: 2.02 g of sodium 1-heptanesulfonate and 4.08 g of potassium dihydrogen phosphate in 1 L of water. Adjust with phosphoric acid to a pH of 2.0.
Mobile phase: Acetonitrile and Buffer solution (1:3)
Standard solution: 2 µg/mL of USP Articaine Related Compound A , and 1 µg/mL each of USP Articaine Related Compound E RS and USP Articaine Hydrochloride RS in Mobile phase. [NoteThis solution is also used to determine the reporting threshold limit. ]
Sample solution: 1.0 mg/mL of Articaine Hydrochloride in Mobile phase
Detector: UV 276 nm
Column: 4.6-mm × 25-cm; packing L1
Flow rate: 1 mL/min
Injection size: 10 µL
Sample: Standard solution
Resolution: NLT 1.2 between articaine related compound A and articaine related compound E
Samples: Standard solution and Sample solution. [NoteRun time is 5 times the retention time of articaine. ]
Calculate the percentage of any articaine related compound A in the portion of Articaine Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × 100
Calculate the percentage of each individual impurity in the portion of Articaine Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × 100
[NoteDisregard any peak below 0.05%. ]
Individual impurities: See Impurity Table 1.
Total impurities: NMT 0.5%. [NoteExcluding articaine related compound A. ]
Impurity Table 1
• Loss on Drying 731: Dry at 105 for 5 h: it loses NMT 0.5% of its weight.
• pH 791
Sample solution: 10 mg/mL
Acceptance criteria: 4.25.2
• Packaging and Storage: Preserve in light-resistant containers.
• USP Reference Standards 11
USP Articaine Hydrochloride RS
USP Articaine Related Compound A RS
Methyl 4-methyl-3-[2-(propylamino) acetamido]thiophene-2-carboxylate.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2241Pharmacopeial Forum: Volume No. 35(3) Page 544