Description

Tenecteplase is a recombinant tissue plasminogen activator (tPA) engineered for enhanced fibrin specificity and resistance to plasminogen activator inhibitor-1. This thrombolytic agent is critical for the rapid and effective dissolution of pathological blood clots in acute medical settings. It is primarily required by pharmaceutical manufacturers and research institutions developing treatments for acute myocardial infarction, ischemic stroke, and other thrombotic emergencies. The product referenced is identified by CAS NO 191588-94-0.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in lyophilized injectable formulations for thrombolytic therapy.
• Acute Myocardial Infarction (AMI) Treatment: Used in the formulation of drugs for the emergency management of heart attacks to restore coronary artery blood flow.
• Acute Ischemic Stroke Therapy: A key component in medications designed to dissolve clots causing strokes, subject to strict time-window protocols.
• Biopharmaceutical Research: Serves as a reference standard and material for R&D in cardiovascular and cerebrovascular disease research.
• Drug Delivery System Development: Used in studies focusing on novel delivery mechanisms for protein-based therapeutics.
• Biosimilar Development: Critical raw material for companies developing and testing biosimilar versions of established thrombolytic drugs.

Basic Information

Product Name	Tenecteplase
CAS No.	191588-94-0
Molecular Formula	C2566H3928N746O781S40
Molecular Weight	~58,000 Da (Monomer)
Synonyms	TNK-tPA; TNKase; Metalyse; Recombinant Tenecteplase; Tissue Plasminogen Activator, Recombinant (T103N, N117Q, KHRR 296-299 AAAA); Tenecteplase (genetical recombination)
EINECS	Contact for details

Quality Control

Our Tenecteplase is manufactured and tested under strict quality systems suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing including identity, purity, potency, and impurity profiling to ensure it meets exacting standards. A Certificate of Analysis (COA) detailing specifications such as biological activity (IU/mg), purity by SE-HPLC and RP-HPLC, and limits for related proteins and process-related impurities is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -20°C or below. Under these conditions, the product is stable for the period indicated on the label. Allow to equilibrate to room temperature before opening to minimize moisture condensation. This material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White or off-white lyophilized powder or solid
Identification (HPLC/MS)	Conforms to reference standard
Biological Activity	≥ 5.0 x 105 IU/mg
Purity (SE-HPLC)	≥ 98.0 %
Purity (RP-HPLC)	≥ 95.0 %
Single Chain Content	≥ 90.0 %
Protein Content (UV)	90 - 110 % of stated
pH (in solution)	6.5 - 7.5
Residual Moisture (KF)	≤ 3.0 %
Bacterial Endotoxins	< 1.0 EU/mg
Sterility (where applicable)	Sterile

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