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GM501 Gradient 45 % and 90 % consists of silane-coated colloidal silica particles suspended in HEPES-buffered medium.
GM501 Gradient 45 % and 90 % is manufactured according to the following specifications:
- pH 7,20-7,90 (Release criteria: 7,20-7,60)
- Osmolality (mOsm/kg):
310-340 (GM501 Gradient 45 %)
320-350 (GM501 Gradient 90 %)
- Density (g/ml): 1,1050-1,1150 (GM501 Gradient 90 %)
- Viscosity (cP): < 1,65 (GM501 Gradient 90 %)
- Sterilityt: sterile – SAL10-3 (Sterility Assurance Level)
- Endotoxins (EU/ml): < 0,5
- Sperm Survival test (%): ≥ 80
survival after 4 hours
exposure of density selected
spermatozoa to the test medium
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