1612619

N-Acetylneuraminic acid

United States Pharmacopeia (USP) Reference Standard

• Synonyme(s) : N-Acetylneuraminic acid dihydrate, o-Sialic acid
• Formule empirique (notation de Hill) : C₁₁H₁₉NO₉ · 2H₂O
• Numéro CAS: 131-48-6
• Poids moléculaire : 345.30
• Numéro MDL: MFCD00006620
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: pharmaceutical primary standard
• Famille d'API: n-acetylneuraminic acid
• Forme: powder
• Fabricant/nom de marque: USP
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: -65 to -96°C
• Chaîne SMILES: N([C@H]1[C@@H](O[C@](C[C@@H]1O)(O)C(=O)O)[C@H](O)[C@H](O)CO)C(=O)C
• InChI: 1S/C11H19NO9/c1-4(14)12-7-5(15)2-11(20,10(18)19)21-9(7)8(17)6(16)3-13/h5-9,13,15-17,20H,2-3H2,1H3,(H,12,14)(H,18,19)/t5-,6+,7+,8+,9+,11-/m0/s1
• Clé InChI: SQVRNKJHWKZAKO-PFQGKNLYSA-N

Description

Description générale

N-Acetylneuraminic acid (Neu5Ac) is the most abundant sialic acid found on the terminal positions of glycan chains in glycoproteins and glycolipids. It plays a critical role in cell signaling and pathogen recognition. The USP standard supports identification and quantitation in glycosylation analysis of biopharmaceuticals.

The USP biologics carbohydrates category includes a variety of carbohydrate-based substances that are essential in the development and manufacturing of therapeutic products. These carbohydrates play crucial roles in biological processes and are often utilized as excipients, stabilizers, or active ingredients in pharmaceuticals. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of carbohydrate 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

N-Acetylneuraminic acid USP reference standard for use in specified quality tests and assays.

Also used to prepare standard stock solution during oligosaccharide and sialic acid analysis according to the given general chapters of United States Pharmacopeia (USP):

• 〈210〉 Monosaccharide analysis
• 〈129〉 Analytical procedures for recombinant therapeutic monoclonal antibodies

Remarque sur l'analyse

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.  ​

Autres remarques

This product is part of the USP Biologics program.

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, 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.

Sales restrictions may apply.

Informations sur la sécurité

• Pictogrammes: GHS07
• Mention d'avertissement: Warning
• Mentions de danger: H319
• Conseils de prudence: P264 - P280 - P305 + P351 + P338 - P337 + P313
• Classification des risques: Eye Irrit. 2
• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 2
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable