Printed on: Thu Feb 09 2023, 12:28:35 AM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-EAACF52C-B739-4339-AF0D-38DBAC2E9152_1_en-US

Printed by: Dang Van Vu Official Date: Official Prior to 2013 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: p0llk DOI: https://doi.org/10.31003/USPNF_M56980_01_01
1

CU = nominal concentration of nitroglycerin in the

Nitroglycerin Sublingual Tablets Sample solution (mg/mL)
DEFINITION
Acceptance criteria: 90.0%–115.0%
Nitroglycerin Sublingual Tablets contain NLT 90.0% and NMT
115.0% of the labeled amount of nitroglycerin (C3H5N3O9). PERFORMANCE TESTS
• DISINTEGRATION á701ñ
IDENTIFICATION Determined as set forth for Sublingual Tablets
• A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST Time: 2 min
á201ñ Acceptance criteria: Meets the requirements
Standard solution: Equivalent to 1 mg/mL of nitroglycerin • UNIFORMITY OF DOSAGE UNITS á905ñ
in acetone from USP Diluted Nitroglycerin RS Procedure for content uniformity
Sample solution: Equivalent to 1 mg/mL of nitroglycerin Mobile phase, Standard solution, Chromatographic
from powdered Sublingual Tablets, in acetone. Shake by system, and System suitability: Proceed as directed in
mechanical means for 30 min, and filter. the Assay.
Developing solvent system: Toluene, ethyl acetate, and Sample solution: 0.075 mg/mL of nitroglycerin in
glacial acetic acid (16:4:1) Mobile phase, from 1 Sublingual Tablet
Analysis: Proceed as directed. Spray with a solution (1 in Analysis
100) of diphenylamine in methanol, and irradiate the plate Samples: Standard solution and Sample solution
with short- and long-wavelength UV light for 10 min. Calculate the percentage of the labeled amount of
Acceptance criteria: Meets the requirements nitroglycerin (C3H5N3O9) in the Sublingual Tablet
• B. The retention time of the Sample solution corresponds to
taken:
that of the Standard solution, as obtained in the Assay.

al
ASSAY Result = (rU/rS) × (CS/CU) × 100
• PROCEDURE
Mobile phase: Methanol and water (50:50) rU = peak response from the Sample solution
Standard solution: 0.075 mg/mL of nitroglycerin from USP rS = peak response from the Standard solution
Diluted Nitroglycerin RS in Mobile phase
ci CS = concentration of nitroglycerin in the Standard
Sample solution: Nominally equivalent to 0.075 mg/mL of solution (mg/mL)
nitroglycerin from powdered Sublingual Tablets (NLT 20 CU = nominal concentration of nitroglycerin in the
Sublingual Tablets) in Mobile phase Sample solution (mg/mL)
Chromatographic system
(See Chromatography á621ñ, System Suitability.) Acceptance criteria: The content of each of the 10
ffi
Mode: LC Sublingual Tablets is within the range of 75.0%–135.0%
Detector: UV 220 nm of the labeled claim. If the content of NMT 1 Sublingual
Column: 4.6-mm × 25-cm; packing L1. [NOTE—If Tablet is outside the range of 75.0%–135.0% and if the
necessary, use a short precolumn that contains packing content of none of the Sublingual Tablets is outside the
L1.] range of 60.0%–150.0%, test 20 additional units. The
Flow rate: 1 mL/min requirements are met if the content of each of the
O

Injection volume: 20 µL additional 20 units falls within the range of 75.0%–

System suitability 135.0% of the labeled claim.
Sample: Standard solution ADDITIONAL REQUIREMENTS
Suitability requirements • PACKAGING AND STORAGE: Preserve in tight containers,
Column efficiency: NLT 3000 theoretical plates preferably of glass, and store at controlled room
Tailing factor: NMT 2.5 temperature. Each container holds NMT 100 Sublingual
Relative standard deviation: NMT 3.0% Tablets.
Analysis • LABELING: The labeling indicates that the Sublingual Tablets
Samples: Standard solution and Sample solution are for sublingual use, and the label directs that the
Calculate the percentage of the labeled amount of Sublingual Tablets be dispensed in the original, unopened
nitroglycerin (C3H5N3O9) in the portion of Sublingual container, labeled with the following statement directed to
Tablets taken: the patient. “Warning: To prevent loss of potency, keep
these tablets in the original container or in a supplemental
Result = (rU/rS) × (CS/CU) × 100 nitroglycerin container specifically labeled as being suitable
rU = peak response from the Sample solution for Nitroglycerin Sublingual Tablets. Close tightly
immediately after each use.”
rS = peak response from the Standard solution • USP REFERENCE STANDARDS á11ñ
CS = concentration of nitroglycerin in the Standard USP Diluted Nitroglycerin RS
solution (mg/mL)

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