Dopamine Hydrochloride 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

Dopamine Hydrochloride Injection is a sterile solution of Dopamine Hydrochloride in Water for Injection. It contains NLT 95.0% and NMT 105.0% of the labeled amount of dopamine hydrochloride (C₈H₁₁NO₂ · HCl). It may contain a suitable antioxidant.

[NOTE-Do not use the Injection if it is darker than slightly yellow or discolored in any other way.]

2 IDENTIFICATION

A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST (201)

Standard solution: 1.6 mg/mL of USP Dopamine Hydrochloride RS in dilute methanol (1:5)

Sample solution: Nominally 1.6 mg/mL of dopamine hydrochloride prepared as follows. Transfer a volume of Injection to a suitable container, and dilute if necessary, with dilute methanol (1:5).

Chromatographic system

Application volume: 5 µL

Developing solvent system: n-Butyl alcohol, glacial acetic acid, and water (4:1:1)

Analysis

Samples: Standard solution and Sample solution

Acceptance criteria: The R, value of the principal spot from the Sample solution corresponds to that from the Standard solution.

3 ASSAY

PROCEDURE

Solution A: 0.005 M sodium 1-octanesulfonate in 1% glacial acetic acid

Mobile phase: Acetonitrile and Solution A, (13:87). Filtered and degassed.

System suitability stock solution A: About 20 mg/ml of benzoic acid in methanol

System suitability stock solution B: About 5 mg/mL of benzoic acid from System suitability stock solution A prepared as follows. Dilute the

System suitability stock solution A with Mobile phase (1:3, v/v).

Standard stock solution: About 1.6 mg/mL of USP Dopamine Hydrochloride RS in Mobile phase

System suitability solution: 0.16 mg/mL of USP Dopamine Hydrochloride RS and 0.5 mg/mL of benzoic acid prepared as follows. Transfer 10.0 mL of System suitability stock solution B and 10.0 mL of Standard stock solution to a 100-ml volumetric flask, dilute with Mobile phase to volume.

Standard solution: About 0.16 mg/mL of USP Dopamine Hydrochloride RS from the Standard stock solution in Mobile phase

Sample solution: Nominally 0.16 mg/mL of dopamine hydrochloride prepared as follows. Transfer an accurately measured volume of Injection, equivalent to about 16 mg of dopamine hydrochloride, to a 100-ml volumetric flask, dilute with Mobile phase to volume.

Chromatographic system

(See Chromatography (621), System suitability.)

Mode: LC

Detector: UV 280 nm

Column: 4-mm x 30-cm; packing 11

Flow rate: 1.5 mL/min

Injection volume: 40 µL

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 4.0 between benzoic acid and dopamine hydrochloride, System suitability solution

Relative standard deviation: NMT 3.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of dopamine hydrochloride (C₈H₁₁NO₂ · HCl) in the portion of Injection taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response of dopamine from the Sample solution

r_s = peak response of dopamine from the Standard solution

C_s = concentration of USP Dopamine Hydrochloride RS in the Standard solution (mg/mL)

C_u = nominal concentration of dopamine hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 95.0%–105.0%

4 SPECIFIC TESTS

BACTERIAL ENDOTOXINS TEST (85): NMT 16.67 USP Endotoxin Units/mg of dopamine hydrochloride

PARTICULATE MATTER IN INJECTIONS (788): Meets the requirements for small-volume injections

PH (791): 2.5-5.0

OTHER REQUIREMENTS: It meets the requirements in Injections and Implanted Drug Products (1).

5 ADDITIONAL REQUIREMENTS

Change to read:

PACKAGING AND STORAGE: Preserve in single-dose containers, preferably (RB 1-Sep-2020) of Type I glass.

LABELING: Label it to indicate that the Injection is to be diluted with a suitable parenteral vehicle prior to intravenous infusion.

USP REFERENCE STANDARDS (11)

USP Dopamine Hydrochloride RS