Certificate of Analysis and Data Sheet

Source:
E.Coli

Catalog No.
ENZ-315

Description :

Recombinant Streptokinase produced in E.Coli is a non-glycosylated polypeptide chain containing 414 amino acids and having a molecular weight of 47kd. Recombinant Streptokinase is purified by proprietary chromatographic techniques.

Physical Appearance:

Sterile Filtered White lyophilized (freeze-dried) powder.

Formulation:

Streptokinase (1.5MIU) was lyophilized from a sterile solution containing 12.5mg HAS, 2.3mg Sodium phosphate dibasic, 0.55mg sodium phosphate monobasic buffer and 4.2 mg Sodium glutamate monohydrate.

Solubility:

It is recommended to reconstitute the lyophilized Streptokinase in sterile 18MO-cm H2O not less than 100ug/ml, which can then be further diluted to other aqueous solutions.

Stability:

Lyophilized Streptokinase although stable at room temperature for 3 weeks, should be stored desiccated below -18 C. Upon reconstitution Streptokinase should be stored at 4 C between 2-7 days and for future use below -18 C. For long term storage it is recommended to add a carrier protein (0.1% HSA or BSA).
Please avoid freeze-thaw cycles.

Purity:

Greater than 98.0% as determined by:
(a) Analysis by RP-HPLC.
(b) Anion-exchange FPLC.
(c) Analysis by reducing and non-reducing SDS-PAGE Silver Stained gel.

Dimers and aggregates:

Less than 1% as determined by silver-stained SDS-PAGE gel analysis.

Biological activity:

ProSpec's Streptokinase is fully biologically active when compared to standard. One unit will liquify a standard clot of fibrinogen, plasminogen and thrombin at pH 7.5 at 37蚓 in 10 min..

Endotoxin:

Less than 0.1 ng/ug (IEU/ug) of Streptokinase.

Usage:

Prospec's products are furnished for LABORATORY RESEARCH USE ONLY. The product may not be used as drugs, agricultural or pesticidal products, food additives or household chemicals.

Latest Publications:

1. Streptokinase-induced hypotension has no detrimental effect on patients with thrombolytic treatment for acute myocardial infarction. A substudy of the Romanian Study for Accelerated Streptokinase in Acute Myocardial Infarction (ASK-ROMANIA).
Rom J Intern Med 2004;42(3):557-73
2. A rapid agglutination assay to detect anti-streptokinase antibodies.
Ir J Med Sci 2004 Oct-Dec;173(4):204-10
3. Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction.
BMC Clin Pharmacol 2005 Nov 2;5:5
4. High-dose streptokinase in the treatment of acute massive pulmonary embolism complicated with cardiogenic shock, respiratory ar rest and ventricular fibrillation.
Vojnosanit Pregl 2005 Jul-Aug;62(7-8):581-5
5. Indigenous recombinant streptokinase vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial.
Indian J Med Sci 2005 May;59(5):200-7
6. Structural diversity of streptokinase and activation of human plasminogen.
Infect Immun 2005 Jul;73(7):4451-3