Description

Duteplase is a recombinant plasminogen activator, a thrombolytic agent used in the treatment of acute myocardial infarction. This product is critical for its ability to dissolve blood clots and restore blood flow in occluded coronary arteries, offering a vital therapeutic intervention. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of cardiovascular and thrombolytic medications. Duteplase CAS NO 120608-46-0 represents a high-purity active pharmaceutical ingredient (API) for advanced medical applications.

Application

• Pharmaceutical API: Primary active ingredient in thrombolytic drug formulations for acute myocardial infarction (heart attack).
• Biomedical Research: Used as a reference standard in cardiovascular and hematology research studies.
• Drug Development: Serves as a key component in the R&D of new fibrinolytic therapies and combination treatments.
• Clinical Diagnostics: Potential use in in vitro diagnostic assays to study clot lysis mechanisms.
• Biologics Manufacturing: Integral to the production process of biosimilar or generic versions of thrombolytic agents.

Basic Information

Product Name	Duteplase
CAS No.	120608-46-0
Molecular Formula	C2540H3772N700O780S40
Molecular Weight	Approx. 57,000 Da
Synonyms	Recombinant Duteplase; Tissue Plasminogen Activator (t-PA) variant; Plasminogen Activator, Tissue-Type, Recombinant; t-PA (two-chain); BM 06.022; FK2P; Thrombolytic Protein; rt-PA (recombinant tissue plasminogen activator) variant
EINECS	Contact for details

Quality Control

Our Duteplase is manufactured under strict quality systems suitable for pharmaceutical applications. It undergoes rigorous analytical testing to ensure identity, purity, potency, and safety, aligning with ICH Q7 guidelines. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing specifications for assay, biological activity, purity by HPLC, and tests for residual host cell proteins and DNA. Certificates are available upon request to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive). For long-term storage, keep desiccated. Aliquot to avoid repeated freeze-thaw cycles.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (HPLC/MS)	Conforms to reference standard
Purity (SDS-PAGE / SEC-HPLC)	≥ 98.0 %
Assay (Biological Activity)	≥ 500,000 IU/mg
Protein Content (UV)	≥ 95.0 %
Endotoxin (LAL)	< 10 EU/mg
Residual Moisture (KF)	< 3.0 %

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