Description

Bivalirudin is a synthetic 20-amino acid peptide anticoagulant that acts as a direct, reversible inhibitor of thrombin. It is widely used in clinical and pharmaceutical research settings for its high specificity, predictable pharmacokinetics, and reduced risk of immune-mediated complications compared to heparin-based alternatives. Bivalirudin CAS NO 128270-60-0 is essential for manufacturers and developers of antithrombotic therapeutics, diagnostic reagents, and GMP-compliant active pharmaceutical ingredients (APIs). This compound serves critical roles in cardiovascular drug formulation, preclinical safety assessment, and analytical reference standard applications.

Application

• Active pharmaceutical ingredient (API) in anticoagulant drug formulations for percutaneous coronary intervention (PCI)
• Reference standard for HPLC, LC-MS, and bioanalytical method validation in regulatory submissions (FDA, EMA)
• Research tool in thrombosis and hemostasis studies, including thrombin activity assays and enzyme kinetics
• Component in diagnostic kits for coagulation cascade analysis and point-of-care anticoagulant monitoring
• GMP-grade raw material for sterile injectable product development and stability testing
• Calibration standard in clinical chemistry laboratories for therapeutic drug monitoring (TDM)
• Excipient-compatible intermediate in lyophilized formulation development
• Quality control standard for biosimilar development and comparability studies

Basic Information

Product Name	Bivalirudin
CAS No.	128270-60-0
Molecular Formula	C98H138N24O33
Molecular Weight	2180.30 g/mol
Synonyms	Hirulog-1; D-Phe-Pro-Arg-Pro-Gly-Gly-Gly-Gly-Asn-Gly-Asp-Phe-Glu-Glu-Ile-Pro-Glu-Glu-Tyr-Leu; Bivalirudin hydrate; Bivalirudin acetate; Bivalirudin triacetate; Bivalirudin sodium salt; [D-Phe¹,Pro²,Arg³,Pro⁴,Gly⁵,Gly⁶,Gly⁷,Gly⁸,Asn⁹,Gly¹⁰,Asp¹¹,Phe¹²,Glu¹³,Glu¹⁴,Ile¹⁵,Pro¹⁶,Glu¹⁷,Glu¹⁸,Tyr¹⁹,Leu²⁰]-hirudin(53–64); Hirudin(53–64), D-Phe¹,Pro²,Arg³,Pro⁴,Gly⁵,Gly⁶,Gly⁷,Gly⁸,Asn⁹,Gly¹⁰,Asp¹¹,Phe¹²,Glu¹³,Glu¹⁴,Ile¹⁵,Pro¹⁶,Glu¹⁷,Glu¹⁸,Tyr¹⁹,Leu²⁰-
EINECS	Not listed (Notified under REACH as intermediate)

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. All batches meet or exceed specifications for pharmaceutical-grade peptides, including identity confirmation by HPLC retention time, mass spectrometry (MS), and amino acid analysis. Testing includes assay (≥98.5% by HPLC), residual solvents (ICH Q3C compliant), endotoxin levels (<0.5 EU/mg), and microbial limits (USP & EP compliant).

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C under dry, inert conditions (argon or nitrogen atmosphere recommended). Due to its hygroscopic nature, minimize exposure to ambient humidity. Avoid repeated freeze-thaw cycles. For long-term storage, keep desiccated at –20°C.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Observed m/z matches theoretical [M+H]⁺ = 2181.3 ± 0.5
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Single impurity ≤0.5%; Total impurities ≤1.5%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Acetonitrile ≤410 ppm; TFA ≤50 ppm; DCM ≤600 ppm
Endotoxins	<0.5 EU/mg
Microbial Limits	Total aerobic count ≤100 CFU/g; Absence of E. coli, S. aureus, P. aeruginosa, S. typhimurium

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.