» Haloperidol Injection is a sterile solution of Haloperidol in Water for Injection, prepared with the aid of Lactic Acid. It may contain a suitable preservative. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C21H23ClFNO2.
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
Identification The solution prepared for measurement of absorbance in the Assay exhibits a maximum at 245 ± 2 nm.
Bacterial endotoxins 85 It contains not more than 71.4 USP Endotoxin Units per mg of haloperidol.
pH 791: between 3.0 and 3.8.
Other requirements It meets the requirements under Injections 1.
Assay Transfer an accurately measured volume of Injection, equivalent to about 10 mg of haloperidol, to a separator, and add 20 mL of dilute hydrochloric acid (1 in 20). Extract the solution with four 25-mL portions of ether, and wash the combined ether extracts with four 5-mL portions of dilute hydrochloric acid (1 in 20). Proceed as directed in the Assay under Haloperidol Solution, beginning with Discard the ether. Calculate the quantity, in mg, of C21H23ClFNO2 in each mL of Injection taken by the formula:
0.5(C / V)(AU / AS)in which C is the concentration, in µg per mL, of USP Haloperidol RS in the Standard solution; V is the volume, in mL, of Injection taken; and AU and AS are the absorbances of the solution from the Injection and the Standard solution, respectively.
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USP35NF30 Page 3398Pharmacopeial Forum: Volume No. 37(2)