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USP-NF Neomycin Sulfate Cream

This document provides information on neomycin sulfate cream, including its approved composition, packaging and storage requirements, identification tests, minimum fill volume, and assay method. Neomycin sulfate cream contains 90-135% of the labeled amount of neomycin. It must be preserved in well-closed containers, preferably at controlled room temperature. Tests are conducted to verify identity and minimum fill volume. The assay involves extracting the cream with ether and buffer to obtain a stock solution, which is then diluted and tested against a standard to determine neomycin concentration.

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91 views1 page

USP-NF Neomycin Sulfate Cream

This document provides information on neomycin sulfate cream, including its approved composition, packaging and storage requirements, identification tests, minimum fill volume, and assay method. Neomycin sulfate cream contains 90-135% of the labeled amount of neomycin. It must be preserved in well-closed containers, preferably at controlled room temperature. Tests are conducted to verify identity and minimum fill volume. The assay involves extracting the cream with ether and buffer to obtain a stock solution, which is then diluted and tested against a standard to determine neomycin concentration.

Uploaded by

kristina nety
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Printed on: Wed Apr 19 2023, 13:52:40 pm

Printed by: QC Erela


Status: Currently Official on 19-Apr-2023
Official Date: Official Prior to 2013
Document Type: USP
DocId: GUID-6EC5C6EE-AEE1-41DF-A41B-1DDD40B4399B_1_en-US
DOI: https://doi.org/10.31003/USPNF_M55863_01_01
DOI Ref: 0lv1y
Do not distribute
© 2023 USPC

Neomycin Sulfate Cream


» Neomycin Sulfate Cream 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 well-closed containers, preferably at controlled room temperature.
USP Reference standards 〈11〉—
USP Neomycin Sulfate RS
Thin-layer chromatographic identification test 〈201BNP〉: meets the requirements.
Minimum fill 〈755〉: meets the requirements.
Assay—Proceed as directed under Antibiotics—Microbial Assays 〈81〉, using an accurately weighed portion of Cream, equivalent to about 1.75 mg
of neomycin, shaken in a separator with about 50 mL of ether, and extracted with four 20-mL portions of Buffer B.3. Combine the aqueous extracts,
and dilute with Buffer B.3 to an appropriate volume to obtain a stock solution of convenient concentration. Dilute this stock solution quantitatively
and stepwise with Buffer B.3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.

Auxiliary Information - Please check

Topic/Question

NEOMYCIN SULFATE CREAM


Contact

Julie Zhang
AL
for your question in the FAQs before contacting USP.

Expert Committee

BIO42020 Biologics Monographs 4 -


CI
Associate Science & Standards Liaison Antibiotics

Chroma t ogra phic Da t a ba se Inf orma t ion: Chromatographic Database


FI

Most Rec ent ly Appea red In:


Pharm ac ope ial Forum : Volum e No. 28(4)
OF

Pa ge Inf orma t ion:

US P43-NF38 - 3103
US P42-NF37 - 3068
US P41-NF36 - 2883

Current DocID: GUID-6EC5C6EE-AEE1-41DF-A41B-1DDD40B4399B_1_en-US


DOI: https://doi.org/10.31003/USPNF_M55863_01_01
DOI ref: 0lv1y

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