1076013

Bivalirudin

United States Pharmacopeia (USP) Reference Standard

• Synonym(e): D-Phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-α-aspartylL-phenylalanyl-L-α-glutamyl-L-α-glutamyl-L-isoleucyl-L-prolyl-L-α-glutamyl-L-α-glutamyl-L-tyrosyl-L -leucine trifluoroacetate (salt) hydrate
• Empirische Formel (Hill-System): C₉₈H₁₃₈N₂₄O₃₃
• Molekulargewicht: 2180.29
• NACRES: NA.24
• UNSPSC Code: 41116107

Eigenschaften

• API family: bivalirudin
• form: solid
• packaging: pkg of 5 mg
• manufacturer/tradename: USP
• application(s): USP Biologics; pharmaceutical (small molecule)
• format: neat
• storage temp.: −20°C

Beschreibung

General description

Peptide family: Bivalirudin

A direct thrombin inhibitor used in anticoagulation therapy.

The USP biologics peptides category encompasses a diverse range of therapeutic peptides that are essential in managing various medical conditions. These peptides, typically consisting of amino acid sequences of 40 residues or less, are critical for the development of high-quality medicines. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of peptide 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

Bivalirudin 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:

• Bivalirudin for Injection

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.

Sicherheitshinweise

• Lagerklasse: 11 - Combustible Solids
• wgk: WGK 1
• flash_point_f: Not applicable
• flash_point_c: Not applicable