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1458009

USP

Neomycin sulfate

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

Neomycin trisulfate salt, Neomycin B sulfate

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About This Item

Empirical Formula (Hill Notation):
C23H46N6O13 · 3H2SO4
CAS Number:
Molecular Weight:
908.88
UNSPSC Code:
41116107
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

neomycin

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecule)

format

neat

InChI

1S/C23H46N6O13.H2O4S/c24-2-7-13(32)15(34)10(28)21(37-7)40-18-6(27)1-5(26)12(31)20(18)42-23-17(36)19(9(4-30)39-23)41-22-11(29)16(35)14(33)8(3-25)38-22;1-5(2,3)4/h5-23,30-36H,1-4,24-29H2;(H2,1,2,3,4)/t5-,6+,7-,8+,9-,10-,11-,12+,13-,14-,15-,16-,17-,18-,19-,20-,21-,22?,23+;/m1./s1

InChI key

OIXVKQDWLFHVGR-GQTDVWSESA-N

General description

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, the main component being neomycin B sulfate. It has a potency equivalent to NLT 600 µg of neomycin/mg, calculated on the dried basis.
Neomycin sulfate USP reference standard is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including MSDS and any product information leaflets, has been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Neomycin sulfate USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monographs such as:
  • Neomycin Sulfate Tablets
  • Neomycin Sulfate Cream
  • Neomycin Sulfate Ointment
  • Neomycin Sulfate Ophthalmic Ointment
  • Neomycin Sulfate Oral Solution
  • Neomycin Sulfate and Hydrocortisone Cream

Caution

Stock solutions should be filter sterilized and stored at 2-8°C, and are stable at 37°C for 5 days. A 1 mg/mL neomycin solution in .1 M phosphate buffer, pH 8.0 should be used within 14 days when stored at 0-5°C. Solutions should be protected from light or moisture.

Preparation Note

Neomycin sulfate is soluble in H2O at 50 mg/mL, yielding a clear solution.

Other Notes

This product is part of the USP Biologics program.

Legal Information

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

Hazard Classifications

Resp. Sens. 1 - Skin Sens. 1

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Lidocaine Ointment
USP43-NF38 ? 3120: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 28(4) (2013)
Neomycin Sulfate and Hydrocortisone Otic Suspension
USP43-NF38 - 3109: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 49(5) (2013)
Neomycin and Polymyxin B Sulfates Ophthalmic Ointment
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 39(5), 3114-3114 (2017)
Neomycin Sulfate
USPNF 2023 ISSUE 2 - online: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 48(1) (2023)
Neomycin and Polymyxin B Sulfates and Lidocaine Cream
USP43-NF38 - 3126: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 47(4) (2013)

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