1612619

N-Acetylneuraminic acid

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): N-Acetylneuraminic acid dihydrate, o-Sialic acid
• Empirical Formula (Hill Notation): C₁₁H₁₉NO₉ · 2H₂O
• CAS Number: 131-48-6
• Molecular Weight: 345.30
• MDL number: MFCD00006620
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: pharmaceutical primary standard
• API family: n-acetylneuraminic acid
• form: powder
• manufacturer/tradename: USP
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: -65 to -96°C
• SMILES string: 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
• InChI key: SQVRNKJHWKZAKO-PFQGKNLYSA-N

Description

General description

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

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

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.

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H319
• Precautionary Statements: P264 - P280 - P305 + P351 + P338 - P337 + P313
• Hazard Classifications: Eye Irrit. 2
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable