Prilocaine and Epinephrine Injection
» Prilocaine and Epinephrine Injection is a sterile solution prepared from Prilocaine Hydrochloride and Epinephrine with the aid of Hydrochloric Acid in Water for Injection, or a sterile solution of Prilocaine Hydrochloride and Epinephrine Bitartrate in Water for Injection. The content of epinephrine does not exceed 0.002 percent (1 in 50,000). Prilocaine and Epinephrine Injection contains the equivalent of not less than 95.0 percent and not more than 105.0 percent of the labeled amount of prilocaine hydrochloride (C13H20N2O·HCl) and the equivalent of 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 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.
Color and clarity— Using the Injection as the Test solution, proceed as directed for Color and clarity under Epinephrine Injection.
Identification—
A: It responds to Identification test B under Prilocaine Hydrochloride.
B: The chromatogram of the Assay preparation obtained as directed in the Assay for prilocaine hydrochloride exhibits a major peak for prilocaine, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay for prilocaine hydrochloride.
C: The chromatogram of the Assay preparation obtained as directed in the Assay for epinephrine exhibits a major peak for epinephrine, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay for epinephrine.
Bacterial endotoxins 85 It contains not more than 0.9 USP Endotoxin Unit per mg of prilocaine hydrochloride.
pH 791: between 3.3 and 5.5.
Other requirements— It meets the requirements under Injections 1.
Assay for prilocaine hydrochloride—
Mobile phase, Standard preparation, Resolution preparation, and Chromatographic system— Proceed as directed in the Assay under Prilocaine Hydrochloride Injection.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 200 mg of prilocaine hydrochloride, to a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure— [note—Use peak areas where peak responses are indicated.] Separately inject equal volumes (about 10 µL) of the Assay preparation and the Standard preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of prilocaine hydrochloride (C13H20N2O·HCl) in each mL of the Injection taken by the formula:
50(C / V)(rU / rS)
in which C is the concentration, in mg per mL, of USP Prilocaine Hydrochloride RS in the Standard preparation, V is the volume, in mL, of Injection taken, and rU and rS are the prilocaine peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Assay for epinephrine—
Mobile phase— Mix 50 mL of glacial acetic acid and 930 mL of water, and adjust with 1 N sodium hydroxide to a pH of 3.40. Dissolve 1.1 g of sodium 1-heptanesulfonate in this solution, add 1.0 mL of 0.1 M disodium ethylenediaminetetraacetate, and mix. Mix about 9 volumes of this solution with 1 volume of methanol. Filter through a membrane filter (1 µm or finer porosity), and degas. 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 to obtain a solution having a known concentration of about 9 µg of epinephrine bitartrate per mL. Pipet 10 mL of this solution into a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix to obtain a Standard preparation having a known concentration of about 1.8 µg of epinephrine bitartrate per mL.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 50 µg of epinephrine, to a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is fitted with a 30-cm × 3.9-mm stainless steel column packed with packing L1, and is equipped with an electrochemical detector held at a potential of +650 mV, a controller capable of regulating the background current, and a suitable recorder, and it is operated at a temperature between 20 and 25 maintained at ±1.0 of the selected temperature. The flow rate is about 1 mL per minute. Chromatograph the Standard preparation as directed for Procedure: the relative standard deviation of the peak responses of successive injections of the Standard preparation is not more than 1.5%.
Procedure— Separately inject equal volumes (about 20 µL) of the Assay preparation and the Standard preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in µg, of epinephrine (C9H13NO3) in each mL of the Injection taken by the formula:
(183.21 / 333.30)50(C / V)(rU / rS)
in which 183.21 and 333.30 are the molecular weights of epinephrine and epinephrine bitartrate, respectively, C is the concentration, in µg 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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
1-301-816-8143
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3380
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.