Haloperidol Injection
»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 90.0percent and not more than 110.0percent of the labeled amount of C21H23ClFNO2.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,protected from light.
Identification— The solution prepared for measurement of absorbance in the Assayexhibits a maximum at 245±2nm.
Bacterial endotoxins á85ñ— It contains not more than 71.4USP Endotoxin Units per mg of haloperidol.
pHá791ñ: between 3.0and 3.8.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Transfer an accurately measured volume of Injection,equivalent to about 10mg of haloperidol,to a separator,and add 20mLof dilute hydrochloric acid (1in 20).Extract the solution with four 25-mLportions of ether,and wash the combined ether extracts with four 5-mLportions of dilute hydrochloric acid (1in 20).Proceed as directed in the Assayunder Haloperidol Solution,beginning with “Discard the ether.”Calculate the quantity,in mg,of C21H23ClFNO2in each mLof Injection taken by the formula:
0.5(C/V)(AU/AS),
in which Cis the concentration,in µg per mL,of USP Haloperidol RSin the Standard solution,Vis the volume,in mL,of Injection taken,and AUand ASare the absorbances of the solution from the Injection and the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 938
Phone Number:1-301-816-8330