Solvents

Assay (by GC) Min 99.9 %
Water (KF) Max 0.01 %
absorbance at 195 nm Max 0.097
absorbance at 200 nm Max 0.022
absorbance at 230 nm Max 0.004
propionitrile (GC) Max. 0.2 %
non-volatile matter Max. 0.0002 %
free acid (as CH3COOH) Max. 0.001 %
free alkali (as NH3) Max. 0.0001 %
HPLC-gradient at 210 nm Max. 1 mAU
HPLC-gradient at 254 nm Max. 0.2 mAU
baseline drift at 210 nm Max. 12 mAU
fluorescence (chinin) at 254 nm Max. 0.5 ppb
fluorescence (chinin) at 365 nm Max. 0.5 ppb
suitability for the LC-MS complying

CryoSure-DMSO is employed in the course of longterm storage and viability determination of cell and tissue grafts.
DMSO (Dimethyl Sulfoxide) is an intracellular cryoprotective agent which penetrates the cell membrane. It reduces the osmotic charge of the cells during freezing and thawing and antagonizes the osmotic shock.
Furthermore it protects the cells from dehydration and shrinking during freezing and prevents the formation of ice crystals.
CryoSure-DMSO is to be applied as a cryoprotectant for all cells and tissues for which the use of DMSO as a freezing agent is established.
Before transplantation CryoSure-DMSO must be eliminated from the transplant.

Dimethyl Sulfoxide Cryo-Preservative in Multidose

Registered as medical device product in EU for storage of human cells or tissue for transplantation to Medical Device Directive 93/42/EEC.

Features:

* 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;
* Final testing of confectionated products exceeding USP & EP requirements in e.g pyrogens, mycoplasma;
* Containers Fitted with Flipoff-Tearoff Closures.