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 Haloperidol RS. 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.

Residual solvents 467: meets the requirements.

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: 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.

Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives

USP29–NF24 Page 1043

Phone Number : 1-301-816-8330