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Merck
CN

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:
1405-10-3
Molecular Weight:
908.88
MDL number:
MFCD00037007
UNSPSC Code:
41116107
NACRES:
NA.24

Key Documents

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Product Name

Neomycin sulfate, United States Pharmacopeia (USP) Reference Standard

SMILES string

[S](=O)(=O)(O)O.N[C@H]1[C@H](O[C@@H]([C@H]([C@@H]1O)O)CN)O[C@H]2[C@@H]([C@H]([C@@H](C[C@@H]2N)N)O)O[C@@H]3O[C@@H]([C@H]([C@H]3O)OC4O[C@H]([C@H]([C@@H]([C@H]4N)O)O)CN)CO

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

grade

pharmaceutical primary standard

API family

neomycin

form

solid

manufacturer/tradename

USP

application(s)

USP Biologics
pharmaceutical (small molecule)

format

neat

Related Categories

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

Disclaimer

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.

General description

Neomycin sulfate is a complex aminoglycoside antibiotic comprising multiple neomycin components. It is active against Gram-negative bacteria and inhibits protein synthesis by binding to the 30S ribosomal subunit. The USP standard supports microbiological potency assays and chromatographic analysis of bulk and finished products.

The USP biologics antibiotics category includes a wide range of antimicrobial agents that are essential in treating bacterial infections. These antibiotics are derived from various natural sources or synthesized to combat specific pathogens effectively. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of antibiotic therapeutics throughout their lifecycle.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

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.

Other Notes

This product is part of the USP Biologics program.

Preparation Note

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

pictograms

Health hazard
GHS08

signalword

Danger

hcodes

H317,H334

Hazard Classifications

Resp. Sens. 1 - Skin Sens. 1

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

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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 and Hydrocortisone Otic Suspension
USP43-NF38 - 3124: United States Pharmacopeia and National Formulary
United States Pharmacopeia (2013)
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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