Nitroglycerin Injection
» Nitroglycerin Injection is a sterile solution prepared from Diluted Nitroglycerin; the solvent may contain Alcohol, Propylene Glycol, and Water for Injection. Nitroglycerin Injection contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of Nitroglycerin (C3H5N3O9).
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.
Identification— The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation obtained as directed in the Assay.
Bacterial endotoxins 85 It contains not more than 0.1 USP Endotoxin Unit per µg of nitroglycerin.
pH 791: between 3.0 and 6.5, determined potentiometrically in a solution prepared by adding 5 mL of water and 1 drop of saturated potassium chloride solution to 5 mL of the Injection.
Particulate matter 788: meets the requirements under small-volume injections.
Alcohol content, Method II 611: between 90.0% and 110.0% of the labeled amount of C2H5OH, isopropyl alcohol being used as the internal standard.
Other requirements— It meets the requirements under Injections 1.
Mobile phase, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Diluted Nitroglycerin.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 7.5 mg of nitroglycerin, to a 100-mL volumetric flask, dissolve in and dilute with Mobile phase to volume, and mix.
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 C3H5N3O9 in the portion of Injection taken by the formula:
100C(rU / rS)
in which C is the concentration, in mg per mL, of nitroglycerin in the Standard preparation, and rU and rS are the peak responses of nitroglycerin obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Sujatha Ramakrishna, Ph.D.
(MDCV05) Monograph Development-Cardiovascular
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3097
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.