Stability of Hemoglobin Controls

The stability of a quality control product is critical. A good control should continue to give the same result on repeated analysis during the defined life of the control, and must be stable throughout manufacture, transport, distribution and storage.

Degradation of protein occurs as a result of chemical and free radical reactions. The integrity of the control can be damaged from a poorly designed lyophilisation protocol, through repeated freezing and thawing, or as a result of microbial growth. It is important during the design that unwanted reactions and conditions are identified and the production and formulation is planned so that these reactions are inhibited or their rates dramatically reduced. It is also important that any protective additives do not interfere with the analytical methods.

Our controls have been carefully formulated to include a number of protectants and stabilisers that preserve the proteins in their native conformation, resulting in products with exceptional stability of both closed and open vials.