Description

Enoxaparin Sodium is a low molecular weight heparin (LMWH) derivative widely used as an anticoagulant and antithrombotic agent. Its primary value lies in its predictable pharmacokinetic profile and subcutaneous bioavailability, making it a critical active pharmaceutical ingredient (API) for injectable formulations. This product is essential for pharmaceutical manufacturers developing treatments and prophylactics for deep vein thrombosis (DVT), pulmonary embolism, and unstable angina.

Application

• Pharmaceutical API: Primary use as the active ingredient in sterile injectable anticoagulant medications.
• Pre-filled Syringes & Auto-injectors: Formulation into convenient, patient-administered dosage forms for long-term therapy.
• Hospital-use Injectables: Manufacturing of single-dose and multi-dose vials for clinical and surgical settings.
• Thrombosis Prophylaxis: Used in drugs designed to prevent blood clots in high-risk patients post-surgery or during extended immobilization.
• Acute Coronary Syndrome Management: Component of therapeutic regimens for conditions like unstable angina and non-Q-wave myocardial infarction.
• Research & Development: Serves as a reference standard and key material in hematology and cardiovascular drug discovery.
• Biosimilar Development: Critical for companies developing generic or biosimilar versions of branded enoxaparin products.

Basic Information

Product Name	Enoxaparin Sodium
CAS No.	679809-58-6
Molecular Formula	Contact for details
Molecular Weight	Average ~4500 Da (Contact for specific grade)
Synonyms	Enoxaparin
Lovenox (Brand Name)
Clexane (Brand Name)
Low Molecular Weight Heparin Sodium
Heparin, low-molecular-weight, sodium salt
PK 10169
SR 90107A/ORG
EINECS	Contact for details

Quality Control

Our Enoxaparin Sodium is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch is tested to ensure compliance with relevant pharmacopeial standards such as USP and EP monographs for Low-Molecular-Weight Heparins. Key parameters including anti-Factor Xa and anti-Factor IIa activity, molecular weight distribution, and purity are rigorously controlled. A comprehensive Certificate of Analysis (COA) documenting all test results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as specified on the label. This material is hygroscopic (moisture-sensitive) and must be kept in its original packaging under dry conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms
Anti-Factor Xa Activity	90-110% of labeled potency
Anti-Factor IIa Activity	Meets USP/EP ratio requirements
Molecular Weight Distribution	Meets pharmacopeial criteria
pH (Solution)	5.5 - 7.5
Loss on Drying	≤ 5.0%
Protein Impurities	Meets limit test
Bacterial Endotoxins	< 0.01 IU per anti-Factor Xa IU
Sterility (if applicable)	Sterile

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