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 90.0percent and not more than 110.0percent of the labeled amount of Nitroglycerin (C3H5N3O9).
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Ior Type IIglass.
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 preparationcorresponds to that of the Standard preparationobtained as directed in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.1USP Endotoxin Unit per µg of nitroglycerin.
pHá791ñ: between 3.0and 6.5,determined potentiometrically in a solution prepared by adding 5mLof water and 1drop of saturated potassium chloride solution to 5mLof the Injection.
Particulate matter á788ñ: meets the requirements under small-volume injections.
Alcohol content,Method IIá611ñ: 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 á1ñ.
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Diluted Nitroglycerin.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 7.5mg of nitroglycerin,to a 100-mLvolumetric flask,dissolve in and dilute with Mobile phaseto volume,and mix.
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 C3H5N3O9in the portion of Injection taken by the formula:
100C(rU/rS),
in which Cis the concentration,in mg per mL,of nitroglycerin in the Standard preparation,and rUand rSare the peak responses of 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 1386
Phone Number:1-301-816-8305