A: The UV absorption spectrum of a 1 in 20,000 solution exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Epinephrine Bitartrate RS, concomitantly measured.

B: Ultraviolet Absorption 197U—

Solution: 50 µg per mL.

Medium: water.

Test solution: 10 mg per mL, in 0.12 N hydrochloric acid.

(Official January 1, 2007)

Mobile phase— Prepare a filtered and degassed solution of 0.17 N acetic acid. Make adjustments if necessary (see System Suitability under Chromatography 621).

Standard preparation— Dissolve an accurately weighed quantity of USP Epinephrine Bitartrate RS in Mobile phase to obtain a solution having a known concentration of about 150 µg per mL.

Assay preparation— Transfer about 25 mg of Racepinephrine Hydrochloride, accurately weighed, to a 100-mL volumetric flask. Dissolve in and dilute with Mobile phase to volume, and mix. Transfer 4.0 mL of this solution to a 10-mL volumetric flask, dilute with Mobile phase to volume, and mix to obtain a solution containing about 100 µg per mL.

Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 278-nm detector and a 4.6-mm × 15-cm column that contains packing L1. The flow rate is about 2.0 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%.

Procedure— Separately inject equal volumes (about 25 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of C9H13NO3·HCl in the portion of Racepinephrine Hydrochloride taken by the formula: in which C is the concentration, in µg per mL, of USP Epinephrine Bitartrate RS in the Standard preparation, 219.67 and 333.30 are the molecular weights of racepinephrine hydrochloride and epinephrine bitartrate, respectively, and RU and RS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.