Quality Control Methods / Results

Analyses:

• PURITY: >95% by SDS PAGE: Major 78kDa band corresponding to Human Lactoferrin.
• Iron Saturation: 20-40%.
• Total Protein determined by Bradford Protein Assay vs. BSA as reference standard

Comments:

• Bulk quantities available.

HAZARD TESTING & WARNINGS:

Blood samples from donors of raw material used in the manufacture of this product have been tested 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.