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 90.0 percent and not more than 115.0 percent 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 I glass.
USP Reference standards 11
USP Endotoxin RS
USP Sisomicin Sulfate RS
Bacterial endotoxins 85 It contains not more than 1.25 USP Endotoxin Units per mg of netilmicin.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 3.5 and 6.0.
Particulate matter 788: meets the requirements under small-volume injections.
Other requirements It meets the requirements under Injections 1.
Dilute phosphoric acid, Mobile phase, Resolution solution, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Netilmicin Sulfate.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 100 mg of netilmicin, to a low-actinic, 100-mL volumetric flask. Dilute with Mobile phase to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Netilmicin Sulfate. Calculate the quantity, in mg, of netilmicin (C21H41N5O7) in each mL of Injection taken by the formula:
0.1(WS P/50V)(rU / rS)in which V is the volume, in mL, of Injection taken to prepare the Assay preparation, and the other terms are as defined therein.
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USP35NF30 Page 4037Pharmacopeial Forum: Volume No. 30(1) Page 136