(ep'' i nef' rin).
1,2-Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-, (R)-.
()-3,4-Dihydroxy--[(methylamino)methyl]benzyl alcohol [51-43-4].
» Epinephrine contains not less than 97.0 percent and not more than 100.5 percent of C9H13NO3, calculated on the dried basis.
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
Identification To 5 mL of pH 4.0 acid phthalate buffer (see Buffer Solutions in the section Reagents, Indicators, and Solutions) add 0.5 mL of a slightly acid solution of Epinephrine (1 in 1000) and 1.0 mL of 0.1 N iodine. Mix, and allow to stand for 5 minutes. Add 2 mL of sodium thiosulfate solution (1 in 40): a deep red color is produced.
Specific rotation 781S: between 50.0 and 53.5.
Test solution: 20 mg per mL, in 0.6 N hydrochloric acid.
Loss on drying 731 Dry it in vacuum over silica gel for 18 hours: it loses not more than 2.0% of its own weight.
Residue on ignition 281: negligible, from 100 mg.
Limit of adrenalone Its absorptivity (see Spectrophotometry and Light-scattering 851) at 310 nm, determined in a solution in dilute hydrochloric acid (1 in 200) containing 2 mg per mL, is not more than 0.2.
Limit of norepinephrine
Epinephrine standard solution Dilute with methanol an accurately measured volume of a solution of USP Epinephrine Bitartrate RS in formic acid containing about 364 mg per mL to obtain a solution having a concentration of about 20 mg per mL.
Norepinephrine standard solution Dilute with methanol an accurately measured volume of a solution of USP Norepinephrine Bitartrate RS in formic acid containing 16 mg per mL to obtain a solution having a known concentration of 1.6 mg per mL.
Test solution Dissolve 200 mg of Epinephrine in 1.0 mL of formic acid, dilute with methanol to 10.0 mL, and mix.
Procedure Apply 5-µL portions of Epinephrine standard solution, Norepinephrine standard solution, and Test solution to a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry, and develop the chromatogram in an unsaturated tank using a solvent system consisting of a mixture of n-butanol, water, and formic acid (7:2:1) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate in warm circulating air. Spray with Folin-Ciocalteu Phenol TS, followed by sodium carbonate solution (1 in 10): the RF value of the principal spot obtained from the Test solution corresponds to that obtained from the Epinephrine standard solution. Any spot obtained from the Test solution is not larger nor more intense than the spot with the same RF value obtained from the Norepinephrine standard solution, corresponding to not more than 4.0% of norepinephrine.
Assay Dissolve about 300 mg of Epinephrine, accurately weighed, in 50 mL of glacial acetic acid, warming slightly if necessary to effect solution. Add crystal violet TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 18.32 mg of C9H13NO3.
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USP35NF30 Page 3052Pharmacopeial Forum: Volume No. 37(2)