Isoniazid Injection
»Isoniazid Injection is a sterile solution of Isoniazid in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C6H7N3O.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,protected from light.
Labeling— Its package label states that if crystallization has occurred,the Injection should be warmed to redissolve the crystals prior to use.
Identification—
A: The retention time exhibited by isoniazid in the chromatogram of the Assay preparationcorresponds to that of isoniazid in the chromatogram of the Standard preparationas obtained in the Assay.
B: Avolume of Injection,equivalent to about 50mg of isoniazid,responds to Identificationtest Bunder Isoniazid.
Bacterial endotoxins á85ñ— It contains not more than 0.3USP Endotoxin Unit per mg of isoniazid.
pHá791ñ: between 6.0and 7.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase ,Standard preparation,and Chromatographic system—Proceed as directed in the Assayunder Isoniazid.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 100mg of isoniazid,to a 50-mLvolumetric flask.Dilute with Mobile phaseto volume,and mix.Transfer 8.0mLof this solution to a 50-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Isoniazid.Calculate the quantity,in mg,of C6H7N3Oin each mLof the Injection taken by the formula:
312.5(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Isoniazid RSin the Standard preparation,Vis the volume,in mL,of Injection taken,and rUand rSare the peak responses of isoniazid obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1074
Phone Number:1-301-816-8394