Diphenhydramine Hydrochloride Injection
»Diphenhydramine Hydrochloride Injection is a sterile solution of Diphenhydramine Hydrochloride in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C17H21NO·HCl.
Packaging and storage Preserve in single-dose or in multiple-dose containers, preferably of Type I glass, protected from light.
USP Reference standards 11
USP Endotoxin RS
A: Dilute a volume of Injection, equivalent to about 50 mg of diphenhydramine hydrochloride, with 0.03 N sulfuric acid to 25 mL, and proceed as directed under IdentificationOrganic Nitrogenous Bases 181, beginning with Transfer the liquid to a separator: the Injection meets the requirements of the test.
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 3.4 USP Endotoxin Units per mg of diphenhydramine hydrochloride.
pH 791: between 4.0 and 6.5.
Other requirements It meets the requirements under Injections 1.
Mobile phase, Standard preparation, System suitability solution, and Chromatographic systemPrepare as directed in the Assay under Diphenhydramine Hydrochloride.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 50 mg of diphenhydramine hydrochloride, to a 100-mL volumetric flask, dilute with water to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Diphenhydramine Hydrochloride. Calculate the quantity, in mg, of C17H21NO·HCl in each mL of the Injection taken by the formula:
100(C / V)(rU / rS)in which C is the concentration, in mg per mL, of USP Diphenhydramine Hydrochloride 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 2932