Cryo-Preservative reagent

License no. Kor Por. 1857/2567

55% w/v Dimethyl Sulfoxide USP Grade, 5% w/v Dextran 40 USP Grade Cryo-Preservative in Multidose

Registered as a medical device in the EU for storage of human cord blood according to Medical Device Directive 93/42/EEC.

Raw materials are of USP grade according to cGMP and ICH guideline Q7A (precondition to use a substance as an API).
Aseptic filling according to GMP and DIN EN ISO 13408.
Primary packing materials are designed to withstand the strong polar solvent DMSO (covered by stability studies).
Final testing of confectionated products exceeding USP & EP requirements in e.g., pyrogens, mycoplasma, and identity.
The product is tested according to European and United States Pharmacopeia for Sterility, Pyrogens, Endotoxins, Mycoplasma & Vitality.
Containers fitted with flip off-tear off closures.