Racepinephrine Hydrochloride
C9H13NO3·HCl 219.67
»Racepinephrine Hydrochloride is a racemic mixture of the hydrochlorides of the enantiomorphs of epinephrine.It contains not less than 97.0percent and not more than 102.0percent of C9H13NO3·HCl,calculated on the anhydrous basis.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification—
A: The UVabsorption spectrum of a 1in 20,000solution exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Epinephrine Bitartrate RS,concomitantly measured.
Solution: 50µg per mL.
Medium: water.
Specific rotation á781Sñ: between -1and +1.
Test solution: 10mg per mL,in 0.12Nhydrochloric acid.
Water,Method Iá921ñ: not more than 0.5%.
Residue on ignition á281ñ: not more than 0.5%.
Organic volatile impurities,Method Iá467ñ: meets the requirements.
Other requirements— It meets the requirements for Limit of adrenaloneand Limit of norepinephrineunder Racepinephrine.
Assay—
Mobile phase— Prepare a filtered and degassed solution of 0.17Nacetic acid.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Standard preparation— Dissolve an accurately weighed quantity of USP Epinephrine Bitartrate RSin Mobile phaseto obtain a solution having a known concentration of about 150µg per mL.
Assay preparation— Transfer about 25mg of Racepinephrine Hydrochloride,accurately weighed,to a 100-mLvolumetric flask.Dissolve in and dilute with Mobile phaseto volume,and mix.Transfer 4.0mLof this solution to a 10-mLvolumetric flask,dilute with Mobile phaseto volume,and mix to obtain a solution containing about 100µg per mL.
Chromatographic system (see Chromatography á621ñ)—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 2.0mLper 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 25µL)of the Standard preparationand the Assay preparationinto 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 Cis the concentration,in µg per mL,of USP Epinephrine Bitartrate RSin the Standard preparation,219.67and 333.30are the molecular weights of racepinephrine hydrochloride and epinephrine bitartrate,respectively,and RUand RSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1701
Phone Number:1-301-816-8379