Neomycin Sulfate
Neomycin sulfate.
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 fradiaeWaksman (Fam.Streptomycetaceae),or a mixture of two or more such salts.It has a potency equivalent to not less than 600µg 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.
Identification—
A:
It meets the requirements for neomycin under Thin-Layer Chromatographic Identification Test á201BNPñ.
B:
Dissolve about 10mg in 1mLof water,add 5mLof 15Nsulfuric acid,and heat at 100
for 100minutes.Allow to cool,add 10mLof xylene,and shake for 10minutes.Allow to separate,and decant the xylene layer.To the xylene layer add 10mLof p-bromoaniline TS,and shake:a vivid pink-red color develops upon standing.
for 100minutes.Allow to cool,add 10mLof xylene,and shake for 10minutes.Allow to separate,and decant the xylene layer.To the xylene layer add 10mLof p-bromoaniline TS,and shake:a vivid pink-red color develops upon standing.
C:
Asolution (1in 20)responds to the tests for Sulfate á191ñ.
pHá791ñ:
between 5.0and 7.5,in a solution containing 33mg of neomycin per mL.
Loss on drying á731ñ—
Dry about 100mg in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 8.0%of its weight.
for 3hours: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 Sterilityand Bacterial endotoxinsunder 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 endotoxinsunder 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 Antibiotics—Microbial Assays á81ñ.
Auxiliary Information—
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1342
Pharmacopeial Forum:Volume No.28(4)Page 1151
Phone Number:1-301-816-8335