Racepinephrine Hydrochloride
C9H13NO3·HCl
![]() ![]() ![]() ![]() ![]() » 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·HCl, calculated on the anhydrous basis.
Packaging and storage
Preserve in tight, light-resistant containers.
Identification
A:
Ultraviolet Absorption
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Solution:
50 µg per mL. [noteUse 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
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Water, Method I
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Residue on ignition
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Other requirements
It meets the requirements for Limit of adrenalone and Limit of norepinephrine under Racepinephrine.
Assay
Mobile phase
Prepare a filtered and degassed solution of 0.17 N acetic acid. Make adjustments if necessary (see System Suitability under Chromatography
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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
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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:
0.25C(219.67 / 333.30)(rU / rS)
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.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 3470
Pharmacopeial Forum: Volume No. 32(6) Page 1752
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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