Racepinephrine Hydrochloride

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₉H₁₃NO₃ . HCI  219.67

Racepinephrine Hydrochloride is a racemic mixture of the hydrochlorides of the enantiomorphs of epinephrine. It contains not less than 97.0 percent and not more than 102.0 percent of C₉H₁₃NO₃ . HCI, calculated on the anhydrous basis.

Packaging and storage-Preserve in tight, light-resistant containers.

Change to read:

1 USP REFERENCE STANDARDS (11)

(CN 1-May-2018)

USP Epinephrine Bitartrate RSA (ERR 1-Aug-2018)

USP Norepinephrine Bitartrate RS

2 Identification

Change to read:

A: Spectroscopic Identification Tests (197), Ultraviolet-Visible Spectroscopy: 197U (CN 1-May-2020)

Solution: 50 µg per mL. [NOTE-Use USP Epinephrine Bitartrate RS in the preparation of the Standard solution.]

Medium: water.

B: A solution (1 in 100) meets the requirements of the tests for Chloride (191)

SPECIFIC ROTATION (781S): between -1° and +1°.

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

WATER DETERMINATION, Method / (921): not more than 0.5%.

RESIDUE ON IGNITION (281): not more than 0.5%.

Other requirements-It meets the requirements for Limit of adrenalone and Limit of norepinephrine under Racepinephrine.

3 Assay

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 x 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 . HCI in the portion of Racepinephrine Hydrochloride taken by the formula:

0.25C(219.67/333.30) (r_U/r_S)

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 r_U and r_S are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.