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 
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.
Auxiliary Information—
Staff Liaison :
Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1491
Pharmacopeial Forum : Volume No. 28(4) Page 1151
Phone Number : 1-301-816-8223
