1076035

[des-Glu13]-Bivalirudin

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): D-Phenylalanyl-L-prolyl-L-arginyl-L-prolylglycylglycylglycylglycyl-L-asparaginylglycyl -L-alpha-aspartyl-L-phenylalanyl-L-alpha-glutamyl-L-isoleucyl-L-prolyl-L-alpha-glutamyl-L-alpha-glutamyl-L-tyrosyl-L-leucine
• Empirical Formula (Hill Notation): C₉₃H₁₃₁N₂₃O₃₀
• CAS Number: 1107611-94-8
• Molecular Weight: 2051.17
• MDL number: MFCD01730597
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• API family: bivalirudin
• form: solid
• packaging: pkg of 1 mg
• manufacturer/tradename: USP
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: −20°C

Description

General description

Peptide family: Bivalirudin

A direct thrombin inhibitor used in anticoagulation therapy. It belongs to the family of peptide anticoagulants.

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

[des-Glu13]-Bivalirudin USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monograph such as Bivalirudin.

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 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.

Sales restrictions may apply.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable