Nitroglycerin Tablets
»Nitroglycerin Tablets contain not less than 90.0percent and not more than 115.0percent of the labeled amount of Nitroglycerin (C3H5N3O9).
Packaging and storage— Preserve in tight containers,preferably of glass,at controlled room temperature.Each container holds not more than 100Tablets.
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 á201ñ—
Test solution— Transfer an amount of finely powdered Tablets,equivalent to about 1mg of nitroglycerin,to a glass-stoppered vessel,add 1mLof acetone,shake by mechanical means for 30minutes,and filter.
Standard solution: 1mg 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 (1in 100),and irradiate the plate with short-and long-wavelength UVlight for about 10minutes.
B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Disintegration á701ñ: 2minutes,determined as set forth for Sublingual Tablets.
Uniformity of dosage units á905ñ: meet the requirements.
PROCEDUREFOR CONTENT UNIFORMITY—
Mobile phase,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder Diluted Nitroglycerin.
Test preparation— Transfer 1Tablet to a suitable container,and dissolve in and dilute with Mobile phaseto obtain a solution containing about 0.075mg of nitroglycerin per mL.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Test preparationinto 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 Vis the volume,in mL,of Mobile phaseused to prepare the Test preparation;Cis the concentration,in mg per mL,of USP Diluted Nitroglycerin RSin the Standard preparation;and rUand rSare the peak responses for nitroglycerin obtained from the Test preparationand the Standard preparation,respectively.The content of each of the 10Tablets is within the range of 75.0%and 135.0%of the labeled claim.If the content of not more than 1Tablet 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 20additional units.The requirements are met if the content of each of the additional 20units falls within the range of 75.0%and 135.0%of the labeled claim.
Assay—
Mobile phase,Standard preparation,andChromatographic system— Prepare as directed in the Assayunder Diluted Nitroglycerin.
Assay preparation— Dissolve not fewer than 20Tablets in Mobile phase,and dilute quantitatively,and stepwise if necessary,with Mobile phaseto obtain a solution containing about 0.075mg per mLof nitroglycerin.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto 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 Tis the number of Tablets taken;Dis the dilution factor of the Assay preparation;Cis the concentration,in mg per mL,of USP Diluted Nitroglycerin RSin the Standard preparation;and rUand rSare the peak responses for nitroglycerin obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1387
Pharmacopeial Forum:Volume No.30(4)Page 1272
Phone Number:1-301-816-8305
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