55% w/v Dimethyl Sulfoxide USP Grade, 5% w/v Dextran 40 USP Grade Cryo-Preservative in Multidose
Registered as medical device in 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 guidline 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 Pharmacopea for Sterility, Pyrogens, Endotoxins, Mycoplasma & Vitality;
- Containers Fitted with Flipoff-Tearoff Closures.