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3558 Irbesartan / Official Monographs USP 35 1-Pentanoylamino-cyclopentanecarboxylic acid [2 ′-(1H-tet- and dropwise, to adjust to a pH of 3.0. Further dilute this solu- razol-5-yl)-byphenyl-4-ylmethyl]-amide. tion with water to a final volume of 1 L. C H N O 446.54 25 30 6 2 phase—Prepare a filtered and degassed mixture of Identification— Buffer solution and acetonitrile (60:40). Make adjustments if nec- A: Infrared Absorption 197K— essary (see System Suitability under Chromatography 621). Test specimen: Transfer 1 Tablet into a suitable vial. Add 10 System suitability preparation—Dissolve accura y weighed mL of methanol, and sonicate for 10 minutes. Pass the solution ties of USP Irbesartan RS and USP Irbesartan Related through a glass microfiber membrane filter having a 0.45- μm or Compound A RS in methanol to obtain a solution having a finer porosity, and evaporate to dr yness, using a stream of ni- known concentration of about 0.1 mg per mL of each of the trogen. Mix approxima y 1 mg of the residue with approxi- USP Reference Standards. ma y 250 mg of potassium bromide, and mix well to obtain a Standard preparation—Dissolve an accura y weighed quan- homogenous mixture. The IR absorption spectrum of a potas- tity of USP Irbesartan RS in methanol to obtain a solution hav- sium bromide dispersion of the residue so obtained exhibits