Description

Lepirudin is a highly specific, direct thrombin inhibitor derived from recombinant DNA technology. This precision anticoagulant is critical for therapeutic applications where heparin is contraindicated, offering a vital alternative for managing thrombotic disorders. It is primarily utilized in the pharmaceutical and biotechnology sectors for the formulation of life-saving anticoagulant therapies, particularly for patients with heparin-induced thrombocytopenia (HIT).

Application

• Anticoagulant Therapy: Primary active pharmaceutical ingredient (API) for the treatment and prevention of thromboembolic complications in patients with heparin-induced thrombocytopenia (HIT).
• Cardiovascular Medicine: Used in acute coronary syndromes and during percutaneous coronary interventions (PCI) as an alternative anticoagulant.
• Research & Development: Serves as a critical reference standard and tool compound in hematology and coagulation research for studying thrombin inhibition mechanisms.
• Pharmaceutical Manufacturing: Incorporated into finished dosage forms, such as injectable solutions, following current Good Manufacturing Practices (cGMP).
• Diagnostic Reagents: Used in the calibration and development of in-vitro diagnostic assays for monitoring coagulation parameters.

Basic Information

Product Name	Lepirudin
CAS No.	138068-37-8
Molecular Formula	C287H440N80O110S6
Molecular Weight	~6979.5 g/mol
Synonyms	Recombinant Hirudin; r-Hirudin; Desulfatohirudin; HBW 023; Hirudin variant-1; Antithrombin recombinant; Lepirudin recombinant; DNA-derived Hirudin; Thrombin-specific inhibitor
EINECS	Contact for details

Quality Control

Our Lepirudin is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) providing results for assay, related proteins, endotoxins, and microbiological examination is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This product is hygroscopic (moisture-sensitive) and must be kept under controlled, dry conditions to maintain stability and potency. For long-term storage, consider keeping the container in a desiccator.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (HPLC/MS)	Conforms to reference standard
Assay (HPLC)	≥ 95.0% (on anhydrous basis)
Potency (Chromogenic Assay)	15,000 - 22,000 ATU/mg
Related Proteins (HPLC)	≤ 5.0% total
Water (Karl Fischer)	≤ 5.0%
Endotoxins (LAL)	< 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.