DiaPharma Human Thrombin

Prepared from a prothrombin complex concentrate extracted from human citrated plasma and fully activated in a purified system. Lyophilized from 1 mL of: 10mM MES, 150mM NaCl, pH 6.5 with PEG 6000 @ 20mg/mL and BSA 10mg/mL. Highly purified, mainly in the α form, with a specific activity of more than 2,000 NIH/mg.

Thrombin activity is reported in harmonized NIH or IU or USP units by reference to the WHO/NIBSC International Standard for Human Thrombin (01/580) (refer to “A unification of the US (“NIH”) and International Unit into a single standard for Thrombin”, Longstaff et al, Thromb Haemost 2005, 93:261‐6)). NIH is a clotting unit for thrombin activity.

Stabilized and lyophilized human Thrombin.

Vial containing approximately 100 NIH of thrombin.

Each vial must be restored with 1 ml distilled water, in order to get a concentration of about 100 NIH/ml. Dilute in the adequate buffer, if necessary.

When tested in the optimized conditions (0.05M Tris buffer at pH 8.4, containing 0.3M NaCl), the following specific activities are observed:

Chromogenic activity on specific substrate (expressed in nKats/μg):

The exact activity in nKats/μg with S‐2238 is reported on the analysis certificate for each lot.

Any product of biological origin must then be handled with all the required cautions, as being potentially infectious.

Restored:

• 7 days at room temperature (18‐25°C).
• 21 days at 2‐8°C.
• 6 months at ‐30°C or below.

Lyophilized: Until the expiration date printed on the vial.