1458031

Neomycin Sulfate System Suitability Mixture

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): (2R,3S,4R,5R,6R)-5-Amino-2-(aminomethyl)-6-[(1R,2R,3S,4R,6S)-4,6-diamino-2-[(2S,3R,4S,5R)-4-[(2R,3R,4R,5S,6S)-3-amino-6-(aminomethyl)-4,5-dihydroxyoxan-2-yl]oxy-3-hydroxy-5-(hydroxymethyl)oxolan-2-yl]oxy-3-hydroxycyclohexyl]oxyoxane-3,4-diol sulfuric acid
• 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

• API family: neomycin
• form: solid
• manufacturer/tradename: USP
• application(s): USP Biologics; pharmaceutical (small molecule)
• format: neat
• storage temp.: −20°C
• 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](O[C@H]([C@@H]2O)O[C@H]3[C@@H]([C@H](C[C@H]([C@@H]3O)N)N)O[C@H]4O[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-WQDIDPJDSA-N

Description

General description

The Neomycin Sulfate System Suitability Mixture is a composite USP reference material comprising defined proportions of neomycin components. It is used to assess the resolution and performance of chromatographic systems during neomycin analysis. This standard ensures assay reproducibility and accuracy in pharmaceutical quality control environments.

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.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  

Other Notes

Sales restrictions may apply.

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

This product is part of the USP Biologics program.

Safety Information

• pictograms: GHS08
• signalword: Danger
• hcodes: H317,H334
• pcodes: P261 - P272 - P280 - P284 - P302 + P352 - P304 + P340 + P312
• 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