Nitroglycerin 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

Nitroglycerin Injection is a sterile solution prepared from Diluted Nitroglycerin; the solvent may contain Alcohol, Propylene Glycol, and Water for Injection. Nitroglycerin Injection contains NLT 90.0% and NMT 110.0% of the labeled amount of nitroglycerin (C₃H₅N₃O₉).

2 IDENTIFICATION

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

3 ASSAY

3.1 Procedure

Mobile phase: Methanol and water (500:500)

Standard solution: 0.075 mg/mL of nitroglycerin from USP Diluted Nitroglycerin RS in Mobile phase

Sample solution: Transfer a measured volume of Injection equivalent to 7.5 mg of nitroglycerin to a 100-mL volumetric flask, and dissolve in and dilute with Mobile phase to volume.

Chromatographic system

• (See Chromatography 〈621〉, System Suitability.)
• Mode: LC
• Detector: UV 220 nm
• Column: 4.6-mm × 25-cm; packing L1
• [Note-If necessary, a short precolumn that contains packing L1 may be used.]
• Flow rate: 1 mL/min
• Injection volume: 20 µL

System suitability

• Sample: Standard solution
• Suitability requirements
• Column efficiency: NLT 3000 theoretical plates
• Tailing factor: NMT 2.5
• Relative standard deviation: NMT 3.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of nitroglycerin (C₃H₅N₃O₉) in the portion of Injection taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response from the Sample solution

rₛ = peak response from the Standard solution

Cₛ = concentration of nitroglycerin in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%–110.0%

4 OTHER COMPONENTS

4.1 Alcohol Determination, Method II 〈611〉

Sample: Use isopropyl alcohol as the internal standard.

Acceptance criteria: 90.0%–110.0% of the labeled amount of C₃H₅OH

5 SPECIFIC TESTS

Bacterial Endotoxins Test 〈85〉: NMT 0.1 USP Endotoxin Unit/µg of nitroglycerin

pH 〈791〉

• Sample: To 5 mL of the Injection add 5 mL of water and 1 drop of saturated potassium chloride solution.
• Acceptance criteria: 3.0–6.5

Particulate Matter in Injections 〈788〉: Meets the requirements for small-volume injections

Other Requirements: It meets the requirements in Injections and Implanted Drug Products 〈1〉.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or in multiple-dose containers, preferably of Type I or Type II glass.

Labeling: Where necessary, label it to indicate that it is to be diluted before use.

USP Reference Standards 〈11〉

USP Diluted Nitroglycerin RS