Quality Control Methods / Results

Analyses:

• PURITY: : > 99% by SDS PAGE. Major 24 kDa band corresponding to Tn-I
• Western Blot: Identity confirmed using anti-Human Cardiac Tn-I MAb.
• Total Protein determined by Bradford Protein Assay using Bovine IgG as reference standard.

Comments:

Purified by ion-exchange and Tn-C affinity chromatography in urea containing buffers using cardiac troponin complex as starting material.

Optimum Storage Conditions: -25° C or below (Avoid repeated freeze thawing).

HAZARD TESTING & WARNINGS:

Blood samples from tissue donors used in the manufacture of this product have been tested at the donor level for HBsAg, Anti-HIV-1/HIV-2, & HCV by FDA approved methods and all results were non-reactive.

CAUTION: NO TEST CAN GUARANTEE A PRODUCT TO BE NON-INFECTIOUS. THEREFORE, ALL MATERIAL DERIVED FROM HUMAN FLUIDS OR TISSUES SHOULD BE CONSIDERED AS POTENTIALLY INFECTIOUS.

Use Statement: For use in Research or Remanufacture of non-injectable products not subject to license under PHS Act Section 351 only.