Recombinant Hirudin is derived from yeast and the polypeptide chain contains 65 amino acids and its Mw is 6979.5 dalton which is identical to natural Hirudin except for the substitution of leucine for isoleucine at the N-terminal end of the molecule and the absence of a sulfate group on the tyrosine at position 63. The Recombinant Hirudin is purified by proprietary chromatographic techniques.
Greater than 95.0% as determined by: (a) Analysis by RP-HPLC. (b) Analysis by SDS-PAGE.
The biological activity is measured using chromogenic assay, 1 unit is defined as the amount of Hirudin that neutralizes 1 unit of the WHO preparation 89/588 of thrombin. The specific activity was found to be 16,000 ATU/mg protein.
Each mg of protein was lyophilized from a sterile solution containing no 20 mM PBS pH-7 and 2% mannitol.
At ambient temperature. Upon receipt, store the product at the temperature recommended below.
Lyophilized Hirudin although stable at room temperature for 3 weeks, should be stored desiccated below –18°C. Upon reconstitution Hirudin 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 prevent freeze-thaw cycles.
Sterile filtered white lyophilized (freeze-dried) powder.