Racepinephrine Inhalation Solution

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

Racepinephrine Inhalation Solution is a sterile solution of Racepinephrine in Purified Water prepared with the aid of Hydrochloric Acid, or of Racepinephrine Hydrochloride in Purified Water.

It contains NLT 90.0% and NMT 110.0% of the labeled amount of racepinephrine (C₉H₁₃NO₃).

2 IDENTIFICATION

A.

Sample solution: 0.5 mL of Inhalation Solution

Analysis:

To 5 mL of pH 4.0 acid phthalate buffer (see Reagents, Indicators, and Solutions—Buffer Solutions) add the Sample solution and 1.0 mL of 0.1 N iodine. Mix, and allow to stand for 5 min. Add 2 mL of sodium thiosulfate solution (1 in 40).

Acceptance criteria: A deep red color is produced.

3 ASSAY

Procedure

Solution A: 0.05 M monobasic sodium phosphate and methanol (85:15)

Mobile phase: 0.005 M sodium 1-octanesulfonate in Solution A

System suitability solution:

0.04 mg/mL of dopamine hydrochloride and 0.01 mg/mL of USP Epinephrine Bitartrate RS in Solution A

Standard solution:

0.1 mg/mL of USP Epinephrine Bitartrate RS in Solution A

Sample solution:

Nominally 0.055 mg/mL of racepinephrine prepared as follows.

Transfer a suitable volume of Inhalation Solution equivalent to 11 mg of racepinephrine to a suitable volumetric flask, and dilute with Solution A to volume.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 280 nm

Column: 4.6-mm × 25-cm; 5-µm packing L1

Flow rate: 1 mL/min

Injection volume: 10 µL

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements:

Resolution: NLT 5.0 between dopamine and racepinephrine, System suitability solution

Tailing factor: NMT 1.2 for racepinephrine, Standard solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of racepinephrine (C₉H₁₃NO₃) in the portion of Inhalation Solution taken:

Result = (r₁ / r₂) × (Cₛ / Cᵤ) × (Mᵤ / Mₛ) × 100

r₁ = peak response from the Sample solution

r₂ = peak response from the Standard solution

Cₛ = concentration of USP Epinephrine Bitartrate RS in the Standard solution (mg/mL)

Cᵤ = nominal concentration of racepinephrine in the Sample solution (mg/mL)

Mᵤ = molecular weight of racepinephrine, 183.20

Mₛ = molecular weight of epinephrine bitartrate, 333.29

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS

Sterility Tests 〈71〉: Meets the requirements

pH 〈791〉: 2.0–3.5

Color and Clarity

Standard solution:

Dilute 2.0 mL of 0.100 N iodine VS with water to 500 mL.

Sample solution:

A portion of Inhalation Solution

Analysis:

Visually examine the Sample solution in a suitable clear glass test tube against a white background.

Acceptance criteria:

The Sample solution is not pinkish, and it contains no precipitate.

If any yellow color is observed in the Sample solution, concomitantly determine the absorbances of the Sample solution and the Standard solution in 1-cm cells with a suitable spectrophotometer set at 460 nm.

 The absorbance of the Sample solution does not exceed that of the Standard solution.

5 ADDITIONAL REQUIREMENTS

Packaging and Storage:

Preserve in tight, light-resistant containers. Do not freeze.

Labeling:

The label indicates that the Inhalation Solution is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

Add the following:

▲USP Reference Standards 〈11〉

USP Epinephrine Bitartrate RS▲ (ERR 1-Aug-2018)