Neomycins sulfate [1405-10-3].
» Neomycin Sulfate is the sulfate salt of a kind of neomycin, an antibacterial substance produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae), or a mixture of two or more such salts. It has a potency equivalent to not less than 600 µg of neomycin per mg, calculated on the dried basis.
Packaging and storage Preserve in tight, light-resistant containers.
Labeling Where it is intended for use in preparing injectable or other sterile dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable or other sterile dosage forms.
A: It meets the requirements for neomycin under Thin-Layer Chromatographic Identification Test 201BNP.
B: Dissolve about 10 mg in 1 mL of water, add 5 mL of 15 N sulfuric acid, and heat at 100 for 100 minutes. Allow to cool, add 10 mL of xylene, and shake for 10 minutes. Allow to separate, and decant the xylene layer. To the xylene layer add 10 mL of p-bromoaniline TS, and shake: a vivid pink-red color develops upon standing.
C: A solution (1 in 20) responds to the tests for Sulfate 191.
pH 791: between 5.0 and 7.5, in a solution containing 33 mg of neomycin per mL.
Loss on drying 731 Dry about 100 mg in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 8.0% of its weight.
Other requirements Where the label states that Neomycin Sulfate is sterile, it meets the requirements for Sterility and Bacterial endotoxins under Neomycin for Injection. Where the label states that Neomycin Sulfate must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Neomycin for Injection. Where it is intended for use in preparing nonparenteral sterile dosage forms, it is exempt from the requirements for Bacterial endotoxins.
Assay Proceed with Neomycin Sulfate as directed under AntibioticsMicrobial Assays 81.
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USP32NF27 Page 3045Pharmacopeial Forum: Volume No. 28(4) Page 1151