Netilmicin Sulfate Injection
»Netilmicin Sulfate Injection is a sterile solution of Netilmicin Sulfate in Water for Injection.It contains the equivalent of not less than 90.0percent and not more than 115.0percent of the labeled amount of netilmicin (C21H41N5O7).It may contain one or more suitable buffers,chelating agents,and preservatives.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Identification— It responds to Identificationtest Aunder Netilmicin Sulfate.
Bacterial endotoxins á85ñ— It contains not more than 1.25USP Endotoxin Units per mg of netilmicin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pHá791ñ: between 3.5and 6.0.
Particulate matter á788ñ: meets the requirements under small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Change to read:
Assay—
Dilute phosphoric acid,Mobile phase,Resolution solution,Standard preparation,andChromatographic system— Proceed as directed in the Assay under Netilmicin Sulfate.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 100mg of netilmicin,to a low-actinic,100-mLvolumetric flask.Dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assay under Netilmicin Sulfate.Calculate the quantity,in mg,of netilmicin (C21H41N5O7)in each mLof Injection taken by the formula:
0.1(WSP/50V)(rU/rS),
in which Vis the volume,in mL,of Injection taken to prepare the Assay preparation,and the other terms are as defined therein.USP28
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1367
Pharmacopeial Forum:Volume No.30(1)Page 136
Phone Number:1-301-816-8335