Cryo-Preservative reagent

ใบอนุญาตเลขที่ ฆพ.1857/2567

Dimethyl Sulfoxide Cryo-Preservative in Multidose

Registered as a medical device product in the EU for storage of human cells or tissue for transplantation 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.
Final testing of confectionated products exceeding USP & EP requirements in e.g., Pyrogens, mycoplasma.
Containers fitted with flip off - tear off closures.