Procaine Hydrochloride and Epinephrine Injection
» Procaine Hydrochloride and Epinephrine Injection is a sterile solution of Procaine Hydrochloride and Epinephrine Hydrochloride in Water for Injection. The content of epinephrine does not exceed 0.002 percent (1 in 50,000). It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of procaine hydrochloride (C13H20N2O2·HCl), and 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 in multiple-dose, light-resistant containers, preferably of Type I or Type II 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 Procaine Hydrochloride RS.
USP Epinephrine Bitartrate RS.
USP Endotoxin RS.
Color and clarity Using the Injection as the Test solution, proceed as directed for Color and clarity under Epinephrine Injection.
Identification Evaporate a portion of Injection, equivalent to about 20 mg of procaine hydrochloride, on a steam bath just to dryness, and dry over silica gel for 18 hours, protected from light: the residue responds to Identification tests A and B under Procaine Hydrochloride.
Bacterial endotoxins 85 It contains not more than 0.6 USP Endotoxin Unit per mg of procaine hydrochloride.
pH 791: between 3.0 and 5.5.
Content of epinephrine
Alkaline ascorbate reagent Mix 100 mL of alcohol, 80 mL of sodium hydroxide solution (1 in 5), and 8 mL of ascorbic acid solution (1 in 50). Prepare fresh on the day of use.
Standard preparation Place about 18 mg of USP Epinephrine Bitartrate RS, accurately weighed, in a 100-mL volumetric flask, add sodium bisulfite solution (1 in 1000) to volume, and mix. Dilute this solution quantitatively with water to obtain a solution having a known concentration of about 10 µg of epinephrine per mL.
Procedure Pipet a volume of Injection, equivalent to about 10 µg of epinephrine, into a 50-mL beaker. Into another 50-mL beaker pipet 1 mL of Standard preparation. Treat the contents of each beaker as follows. Add 10 mL of dilute hydrochloric acid (1 in 120), and heat gently to reduce the volume of solution to about 5 mL. Allow to cool to room temperature, then add 5 mL of sodium acetate solution (1 in 5), followed by 0.5 mL of potassium ferricyanide solution (1 in 400), and mix. At 2 minutes, accurately timed, after the last addition, add 20 mL of Alkaline ascorbate reagent, transfer the contents to a corresponding 50-mL volumetric flask with the aid of water, add water to volume, and mix. At 15 to 20 minutes after the addition of the Alkaline ascorbate reagent, determine the fluorescences of each solution and of a reagent blank, with a suitable fluorometer, with an excitation wavelength setting of 420 nm and a fluorescence wavelength setting of 520 nm. Calculate the quantity, in µg, of C9H13NO3 in each mL of Injection taken by the formula:
(C / V)[(IU B) / (IS B)]in which C is the concentration of epinephrine, in µg per mL, of USP Epinephrine Bitartrate RS in the Standard preparation, V is the volume, in mL, of Injection taken, and IU, IS, and B are the fluorescence readings of the solutions from the Injection, the Standard preparation, and the reagent blank, respectively.
Other requirements It meets the requirements under Injections 1.
Standard preparation Transfer to a 125-mL separator about 50 mg, accurately weighed, of USP Procaine Hydrochloride RS, and dilute with water to 20 mL.
Assay preparation Transfer to a 125-mL separator an accurately measured volume of Injection, equivalent to about 50 mg of procaine hydrochloride, and dilute with water to 20 mL.
Procedure To the Standard preparation and also to the Assay preparation add 5 mL of 6 N ammonium hydroxide, then treat each as follows. Extract with five 25-mL portions of chloroform, and filter the combined extracts through about 1 g of anhydrous sodium sulfate supported on a pledget of glass wool. Receive the filtrate in a 200-mL volumetric flask, add chloroform to volume, and mix. Transfer 3.0 mL of this solution to a 100-mL volumetric flask, add chloroform to volume, and mix. Concomitantly determine the absorbances of both solutions at the wavelength of maximum absorbance at about 280 nm, with a suitable spectrophotometer, using chloroform as the blank. Calculate the quantity, in mg, of C13H20N2O2·HCl in each mL of the Injection taken by the formula:
(W / V)(AU / AS)in which W is the weight, in mg, of USP Procaine Hydrochloride RS used, V is the volume, in mL, of Injection taken, and AU and AS are the absorbances of the solutions obtained from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 3392