Isoproterenol Hydrochloride Injection
» Isoproterenol Hydrochloride Injection is a sterile solution of Isoproterenol Hydrochloride in Water for Injection. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of isoproterenol hydrochloride (C11H17NO3·HCl).
Packaging and storage Preserve in single-dose containers, preferably of Type I glass, protected from light. Store at controlled room temperature.
Labeling Label it to indicate 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 Using the Injection as the Test solution, proceed as directed for Color and clarity under Isoproterenol Inhalation Solution.
Identification 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 1250.0 USP Endotoxin Units per mg of isoproterenol hydrochloride.
pH 791: between 2.5 and 4.5.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
Mobile phase Dissolve 1.76 g of sodium 1-heptanesulfonate in 800 mL of water. Add 200 mL of methanol, and adjust with 1 M phosphoric acid to a pH of 3.0 ± 0.1. Pass the solution through a membrane filter having a 1-µm or finer porosity.
Standard preparation Dissolve an accurately weighed quantity of USP Isoproterenol Hydrochloride RS in freshly prepared sodium bisulfite solution (1 in 1000) to obtain a solution having a known concentration of about 20 µg per mL.
Resolution solution Prepare a solution of epinephrine bitartrate in freshly prepared Mobile phase containing 1.0% of sodium bisulfite, having a concentration of about 200 µg per mL. Mix 2.0 mL of this solution and 18.0 mL of the Standard preparation.
Assay preparation Quantitatively dilute an accurately measured volume of Injection with freshly prepared sodium bisulfite solution (1 in 1000) to obtain a solution having a concentration of about 20 µg per mL.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 280-nm detector and a 4-mm × 30-cm column that contains packing L1. The flow rate is about 2 mL per 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 1.5%. Chromatograph the Resolution solution: the relative retention times are about 0.55 for epinephrine and 1.0 for isoproterenol; the resolution, R, for epinephrine and isoproterenol is not less than 3.5; and the tailing factors for the epinephrine and isoproterenol peaks are not more than 2.5.
Procedure Separately inject equal volumes (about 100 µL) of the Standard preparation and the Assay preparation, record the chromatograms, and measure the peak responses. Calculate the quantity, in mg, of isoproterenol hydrochloride (C11H17NO3·HCl) in each mL of the Injection taken by the formula:
C(L/D)(rU / rS)in which C is the concentration, in µg per mL, of USP Isoproterenol Hydrochloride RS in the Standard preparation; L is the labeled quantity, in µg per mL, of isoproterenol hydrochloride in the Injection; D is the concentration, in µg per mL, of isoproterenol hydrochloride in the Assay preparation, on the basis of the labeled quantity in each mL and the extent of dilution; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 3580Pharmacopeial Forum: Volume No. 30(2) Page 510