1458009

Neomycin sulfate

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): Neomycin trisulfate salt, Neomycin B sulfate
• Empirical Formula (Hill Notation): C₂₃H₄₆N₆O₁₃ · 3H₂SO₄
• CAS Number: 1405-10-3
• Molecular Weight: 908.88
• MDL number: MFCD00037007
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: pharmaceutical primary standard
• API family: neomycin
• form: solid
• manufacturer/tradename: USP
• application(s): pharmaceutical (small molecule)
• format: neat
• 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

Description

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.

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.

Safety Information

• pictograms: GHS08
• signalword: Danger
• hcodes: H317,H334
• pcodes: P261 - P272 - P280 - P284 - P302 + P352 - P333 + P313
• Hazard Classifications: Resp. Sens. 1 - Skin Sens. 1
• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable