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.
Identification— It responds to Identification test A under Netilmicin Sulfate.
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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Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3072
Pharmacopeial Forum: Volume No. 30(1) Page 136
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.