Haloperidol Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Haloperidol Injection is a sterile solution of Haloperidol in Water for Injection, prepared with the aid of Lactic Acid. It contains NLT 90.0% and NMT 110.0% of the labeled amount of haloperidol (C₂₁H₂₃CIFNO₂). It may contain a suitable preservative.

2 IDENTIFICATION

A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

3.1 PROCEDURE

Buffer solution: 6.8 g/L of monobasic potassium phosphate in water. Adjust with phosphoric acid to a pH of 4.0.

Mobile phase: Methanol and Buffer solution (55:45)

Standard stock solution: 1 mg/mL of USP Haloperidol RS in methanol. Sonicate to aid in dissolution.

Standard solution: 0.2 mg/mL of USP Haloperidol RS in Mobile phase from the Standard stock solution

Sample solution: Nominally, 0.2 mg/mL of haloperidol in Mobile phase from a volume of Injection

3.2 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 247 nm

Column: 4.6-mm × 15-cm; 5-µm packing L1

Flow rate: 0.8 mL/min

Injection size: 10 µL

Run time: 2.5 times the retention time of haloperidol

3.3 System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

3.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of haloperidol (C₂₁H₂₃CIFNO₂) in the portion of Injection taken:

Result = (r_U/r_S) x (C_S/C_U) x 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Haloperidol RS in the Standard solution (mg/mL)

C_U = nominal concentration of haloperidol in the Sample solution (mg/mL)

Acceptance criteria: 90.0%-110.0%

4 SPECIFIC TESTS

4.1 BACTERIAL ENDOTOXINS TEST (85)

It contains NMT 71.4 USP Endotoxin Units/mg of haloperidol.

4.2 PH (791)

3.0-3.8

4.3 OTHER REQUIREMENTS

It meets the requirements under Injections and Implanted Drug Products (1).

5 ADDITIONAL REQUIREMENTS

5.1 PACKAGING AND STORAGE

Preserve in single-dose or in multiple-dose containers, preferably of Type I glass, protected from light. Store at controlled room temperature.

5.2 USP REFERENCE STANDARDS (11)

USP Haloperidol RS