Streptokinase (CAS Number 9002-01-1) Bulk

Thrombolytic enzyme that effectively dissolves clots in myocardial infarction

Product characteristics
• Streptokinase (CAS Number 9002-01-1) is a 47 kDa polypeptide derived from beta-haemolytic Streptococci of Lancefield Group C bacteria
• Streptokinase forms a complex with plasminogen, converting it into the proteolytic enzyme plasmin, which initiates a cascade that ultimately leads to the lysis of fibrin clots and restores blood flow to ischemic tissue
• Streptokinase belongs to a class of drugs called Thrombolytic agents

THERAPEUTIC PROPERTIES
• Acute Myocardial Infarction (Heart Attack)
• Deep Vein Thrombosis
• Pulmonary Embolism
• Arterial thrombosis

Product Features
• Streptokinase is manufactured by fermentation and purified using series of chromatography Methods
• Purity levels ≥99%, confirmed by orthogonal quality control tests
• Comparable biological activity with NIBSC standard as measured by clot lysis and chromogenic substrate assay

GMP Quality Statement
• Personnel training records
• Manufactured and tested under GMP guidelines
• Batch-to-batch consistency
• Testing and traceability of raw material
• Documentation of QA, QC and Production
• Records of the maintenance and equipment calibration
• Stability monitors of product shelf life
• Antibiotic-free and solvent-free manufacturing process
• Animal origin free raw materials
• TSE/BSE free certified and comply with IP/USP/EP/BP
• Following ICH Q7 principles to meet international standards
• Drug Master File (DMF) as per ICH M4 guideline

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