» Epinephrine Injection is a sterile solution of Epinephrine in Water for Injection prepared with the aid of Hydrochloric Acid or other suitable buffers. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of epinephrine (C9H13NO3).
Packaging and storage Preserve in single-dose or multiple-dose, light-resistant containers, preferably of Type I glass.
Labeling The label indicates that the Injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
USP Reference standards 11
USP Endotoxin RS
Color and clarity
Standard solution Transfer 2.0 mL of 0.100 N iodine VS to a 500-mL volumetric flask, dilute with water to volume, and mix.
Procedure Visually examine a portion of the Injection (Test solution) in a suitable clear glass test tube against a white background: it is not pinkish and it contains no precipitate. If any yellow color is observed in the Test solution, concomitantly determine the absorbances of the Test solution and the Standard solution in 1-cm cells with a suitable spectrophotometer set at 460 nm: the absorbance of the Test solution does not exceed that of the Standard solution.
A: It responds to the Identification test under Epinephrine Nasal Solution.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Bacterial endotoxins 85 It contains not more than 357.0 USP Endotoxin Units per mg of epinephrine.
pH 791: between 2.2 and 5.0.
Total acidity Transfer 5.0 mL of Injection to a flask, add 10 mL of water, and titrate with 0.01 N sodium hydroxide VS to a pH of 7.40. Perform a blank determination, and make any necessary correction. Not more than 25.0 mL of 0.01 N sodium hydroxide is required.
Other requirements It meets the requirements under Injections 1.
Mobile phase To 1 L of 0.05 M monobasic sodium phosphate add about 519 mg of sodium 1-octanesulfonate and about 45 mg of edetate disodium, and mix. Adjust by the dropwise addition of phosphoric acid, if necessary, to a pH of 3.8. Mix 85 volumes of this solution with 15 volumes of methanol. 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, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 0.1 mg of epinephrine per mL.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 1 mg of epinephrine, to a 10-mL volumetric flask, dilute with Mobile phase to volume, and mix.
System suitability preparation Dissolve 10 mg of dopamine hydrochloride in 100 mL of the Standard preparation, and mix.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 15-cm column that contains packing L7. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation and the System suitability preparation, and record the peak responses as directed for Procedure: the relative retention times are about 1.0 for epinephrine and 2.0 for dopamine hydrochloride; the resolution, R, between epinephrine and dopamine hydrochloride is not less than 3.5; and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure Separately inject equal volumes (about 20 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 epinephrine (C9H13NO3) in each mL of the Injection taken by the formula:
(183.20/333.29)(10)(C/V)(rU / rS)in which 183.20 and 333.29 are the molecular weights of epinephrine and epinephrine bitartrate, respectively; C is the concentration, in mg per mL, of USP Epinephrine Bitartrate RS in the Standard preparation; V is the volume, in mL, of Injection taken; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 3053Pharmacopeial Forum: Volume No. 31(1) Page 43