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Nitroglycerin Tablets
(Current title—not to change until October 1, 2006)
Monograph title change—to become official October 1, 2006
See Nitroglycerin Sublingual Tablets
» Nitroglycerin Tablets contain not less than 90.0 percent and not more than 115.0 percent of the labeled amount of nitroglycerin (C3H5N3O9).
Packaging and storage— Preserve in tight containers, preferably of glass, and store at controlled room temperature. Each container holds not more than 100 Tablets.
Labeling— The labeling indicates that the Tablets are for sublingual use, and the label directs that the 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 Tablets. Close tightly immediately after each use.”
Identification—
A: Thin-Layer Chromatographic Identification Test 201—
Test solution— Transfer an amount of finely powdered Tablets, equivalent to about 1 mg of nitroglycerin, to a glass-stoppered vessel, add 1 mL of acetone, shake by mechanical means for 30 minutes, and filter.
Standard solution: 1 mg per mL, in acetone.
Developing solvent system: a mixture of toluene, ethyl acetate, and glacial acetic acid (16:4:1).
Procedure— Proceed as directed in the chapter. Spray with a solution of diphenylamine in methanol (1 in 100), and irradiate the plate with short- and long-wavelength UV light for about 10 minutes.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Disintegration 701: 2 minutes, determined as set forth for Sublingual Tablets.
Uniformity of dosage units 905: meet the requirements.
PROCEDURE FOR CONTENT UNIFORMITY—
Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Diluted Nitroglycerin.
Test preparation— Transfer 1 Tablet to a suitable container, and dissolve in and dilute with Mobile phase to obtain a solution containing about 0.075 mg of nitroglycerin per mL.
Procedure— Separately inject equal volumes (about 20 µL) of the Standard preparation and the Test preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of nitroglycerin (C3H5N3O9) in the portion of Tablets taken by the formula:
VC(rU / rS),
in which V is the volume, in mL, of Mobile phase used to prepare the Test preparation; C is the concentration, in mg per mL, of USP Diluted Nitroglycerin RS in the Standard preparation; and rU and rS are the peak responses for nitroglycerin obtained from the Test preparation and the Standard preparation, respectively. The content of each of the 10 Tablets is within the range of 75.0% and 135.0% of the labeled claim. If the content of not more than 1 Tablet is outside the range of 75.0% and 135.0% and if the content of none of the Tablets is outside the range of 60.0% and 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% and 135.0% of the labeled claim.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay—
Mobile phase, Standard preparation, and Chromatographic system— Prepare as directed in the Assay under Diluted Nitroglycerin.
Assay preparation— Dissolve not fewer than 20 Tablets in Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution containing about 0.075 mg per mL of nitroglycerin.
Procedure— Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of nitroglycerin (C3H5N3O9) per Tablet taken by the formula:
100 / (TDC)(rU / rS),
in which T is the number of Tablets taken; D is the dilution factor of the Assay preparation; C is the concentration, in mg per mL, of USP Diluted Nitroglycerin RS in the Standard preparation; and rU and rS are the peak responses for nitroglycerin obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (MDCV05) Monograph Development-Cardiovascular
USP29–NF24 Page 1545
Pharmacopeial Forum : Volume No. 30(4) Page 1272
Phone Number : 1-301-816-8305