Nitroglycerin Sublingual Tablets

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

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

DOWNLOAD PDF HERE

1 DEFINITION

Nitroglycerin Sublingual Tablets contain NLT 90.0% and NMT 115.0% of the labeled amount of nitroglycerin (C₃H₅N₃O₉).

2 IDENTIFICATION

2.1 A. Thin-Layer Chromatographic Identification Test 〈201〉

Standard solution: Equivalent to 1 mg/mL of nitroglycerin in acetone from USP Diluted Nitroglycerin RS

Sample solution: Equivalent to 1 mg/mL of nitroglycerin from powdered Sublingual Tablets, in acetone. Shake by mechanical means for 30 min, and filter.

Developing solvent system: Toluene, ethyl acetate, and glacial acetic acid (16:4:1)

Analysis: Proceed as directed. Spray with a solution (1 in 100) of diphenylamine in methanol, and irradiate the plate with short- and long-wavelength UV light for 10 min.

Acceptance criteria: Meets the requirements

2.2 B. 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 (50:50)

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

Sample solution: Nominally equivalent to 0.075 mg/mL of nitroglycerin from powdered Sublingual Tablets (NLT 20 Sublingual Tablets) in Mobile phase

Chromatographic system

• (See Chromatography 〈621〉, System Suitability.)
• Mode: LC
• Detector: UV 220 nm
• Column: 4.6-mm × 25-cm; packing L1.
• [Note-If necessary, use a short precolumn that contains packing L1.]
• 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 Sublingual Tablets 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 nitroglycerin in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–115.0%

4 PERFORMANCE TESTS

4.1 Disintegration 〈701〉

Determined as set forth for Sublingual Tablets

Time: 2 min

Acceptance criteria: Meets the requirements

4.2 Uniformity of Dosage Units 〈905〉

Procedure for content uniformity

Mobile phase, Standard solution, Chromatographic system, and System suitability: Proceed as directed in the Assay.

Sample solution: 0.075 mg/mL of nitroglycerin in Mobile phase, from 1 Sublingual Tablet

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of nitroglycerin (C₃H₅N₃O₉) in the Sublingual Tablet 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 nitroglycerin in the Sample solution (mg/mL)

Acceptance criteria: The content of each of the 10 Sublingual Tablets is within the range of 75.0%–135.0% of the labeled claim. If the content of NMT 1 Sublingual Tablet is outside the range of 75.0%–135.0% and if the content of none of the Sublingual Tablets is outside the range of 60.0%–150.0%, test 20 additional units. The requirements are met if the content of each of the additional 20 units falls within the range of 75.0%–135.0% of the labeled claim.

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers, preferably of glass, and store at controlled room temperature. Each container holds NMT 100 Sublingual Tablets.

Labeling: The labeling indicates that the Sublingual Tablets are for sublingual use, and the label directs that the Sublingual Tablets be dispensed in the original, unopened container, labeled with the following statement directed to the patient. “Warning: To prevent loss of potency, keep these tablets in the original container or in a supplemental nitroglycerin container specifically labeled as being suitable for Nitroglycerin Sublingual Tablets. Close tightly immediately after each use.”

USP Reference Standards 〈11〉

USP Diluted Nitroglycerin RS