Neomycin Sulfate Ophthalmic Ointment
» Neomycin Sulfate Ophthalmic Ointment is a sterile preparation of Neomycin Sulfate in a suitable ointment base. It contains the equivalent of not less than 90.0 percent and not more than 135.0 percent of the labeled amount of neomycin.
Packaging and storage
Preserve in collapsible ophthalmic ointment tubes.
USP Reference standards 11
USP Neomycin Sulfate RS
Thin-layer chromatographic identification test 201BNP:
meets the requirements.
Sterility 71:
meets the requirements.
Minimum fill 755:
meets the requirements.
Water, Method I 921:
not more than 1.0%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
Metal particles
It meets the requirements of the test for Metal Particles in Ophthalmic Ointments 751.
Assay
Proceed with Ophthalmic Ointment as directed in the Assay under Neomycin Sulfate Ointment.
Auxiliary Information
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USP35NF30 Page 4011
Pharmacopeial Forum: Volume No. 28(4) Page 1153
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