Reference:
DMV5-005, 1 kit (5 ml).
For vitrification (ultra-rapid freezing) and cryostorage of human blastocysts.
Store at 2-8°C and protected from light. One (1) year from the date of manufacture.
Composition:
1 X 5 ml vial of DMSO Equilibration Solution (blue caps)
1 X 5 ml vials of Vitrification Solution (white caps)
10 X embryo GPS® dishes
Base Components:
Sodium Chloride, Potassium Chloride, Calcium Chloride, Sodium Bicarbonate, Glucose, Lactate Na Salt, L-Alanine, L-Arginine HCl, L-Asparagine, L-Glutamic Acid, Glycyl-Glutamine, L-Histidine, L-Lysine HCl, L-Methionine, L-Phenylalanine, L-Threonine, L-Tryptophan, L-Tyrosine, Phenol Red, HEPES, Gentamicin Sulfate* (10 μg/ml).
The solutions in the global® DMSO Blastocyst Vitrification Kit are membrane filtered and aseptically processed according to cGMP procedures which have been validated to meet a sterility assurance level (SAL) of 10-3. |
Assay (performed for each batch) |
Specification |
pH — Equilibration and Vitrification Solutions |
7.1-7.5 |
Osmolality — Equilibration Solution |
2600-3500 mOsM |
Osmolality — Vitrification solution |
4900-6600 mOsM |
Endotoxin (LAL) - Equilibration and Vitrification Solutions |
< 1.0 EU/ml |
Sterility Test (bacterial and fungal screen, SAL 10–3) |
PASS |
1-cell Mouse Embryo Assay (% expanded blastocysts at 96 h of culture following step-in, step-out of vitrification and warming solutions) |
> 80% |
embryo GPS® Dishes |
|
Endotoxin (LAL) |
< 20 EU/device |
1-cell Mouse Embryo Assay (% expanded blastocysts after 96 h) |
> 80% |