Description

Bivalirudin is a synthetic, direct thrombin inhibitor peptide used as an anticoagulant in critical medical procedures. Its high specificity and reversible binding profile make it a valuable alternative to heparin, particularly for patients with heparin-induced thrombocytopenia (HIT). This active pharmaceutical ingredient (API) is essential for manufacturers in the pharmaceutical and biotechnology sectors developing anticoagulant therapies. Bivalirudin CAS NO 1191386-55-6 is supplied under stringent quality controls to meet the demands of global regulatory standards.

Application

• Pharmaceutical API: Primary active ingredient in injectable anticoagulant drugs.
• Cardiovascular Interventions: Used in percutaneous coronary intervention (PCI) and angioplasty procedures.
• Surgical Anticoagulation: Administered during cardiac bypass surgery and other vascular surgeries.
• Treatment for HIT: Critical therapeutic agent for patients with heparin-induced thrombocytopenia.
• Research & Development: Reference standard and building block in cardiovascular and hematology research.
• Drug Formulation: Used in the development of novel parenteral dosage forms and combination products.

Basic Information

Product Name	Bivalirudin
CAS No.	1191386-55-6
Molecular Formula	C98H138N24O33
Molecular Weight	2180.3 g/mol
Synonyms	BG-8967; Hirulog; Angiomax; D-Phe-Pro-Arg-Pro-Gly-Gly-Gly-Gly-Asn-Gly-Asp-Phe-Glu-Glu-Ile-Pro-Glu-Glu-Tyr-Leu; (2R)-2-[[(2S)-2-[[(2S)-2-[[2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-Amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-5-carbamimidamidopentanoyl]amino]-3-hydroxypropanoyl]amino]-4-methylpentanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-carboxypropanoyl]amino]-3-carboxypropanoyl]amino]-4-carbamoylbutanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-5-guanidino-3-methylpentanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-3-carboxypropanoyl]amino]-3-carboxypropanoyl]amino]-4-carbamoylbutanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-3-phenylpropanoyl]amino]-5-guanidinopentanoic acid
EINECS	Contact for details

Quality Control

Our Bivalirudin is manufactured under strict cGMP conditions to ensure the highest standards of purity and consistency. Each batch undergoes comprehensive analytical testing, including HPLC for purity and related substances, residual solvent analysis, and microbiological testing. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with in-house specifications and supporting regulatory filings for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and potency. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 10 EU/mg
Microbial Enumeration	Meets Ph. Eur. 2.6.12 / USP <61>

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