- All raw materials are of highest available purity (European Pharmacopoeia and/or USP standard) if applicable.
- The MSDS for GM501 SpermMobil is available upon request and can be downloaded from our website.
- GM501 SpermMobil is manufactured and tested according to the following specifications:
|pH at 37°C)||7,20-7,60|
|Sterility||sterile – SAL 10-3 (Sterility Assurance Level)|
|Endotoxins (EU/ml)||< 0,50|
|Sperm Survival test (%)survival after 45 minutes exposure of density selected spermatozoa to the test medium||≥ 80%|
NaCl, KCl, KH2PO4, MgSO4.7H2O, NaHCO3, CaCl2.2H2O, D(+)-Glucose Anhydrous, Na-Lactate, Na-Pyruvate, EDTA, Alanyl-Glutamine, water, non-essential and essential Amino Acids, HEPES, Theophylline, Phenol Red.
Instructions for Use
- The intended users are IVF professionals (biologists, lab technicians, embryologists or medical doctors).
- Do not equilibrate GM501 SpermMobil in a CO2-incubator, just warm it up to 37°C. GM501 SpermMobil is HEPES-buffered. Incubation in a CO2-incubator will lower the pH.
- To facilitate sperm-activation add 3-4 μl GM501 SpermMobil to the sperm-containing drop (approx. 30-40μl/ditution 1:10) in sperm preparation-medium inside the Petri-dishes.
- GM501 SpermMobil should be added to the opposing side from where the sperms are to be aspirated.
- Wait for 10 minutes. The activating effect initiates after a few minutes and lasts for up to one hour.
Precautions and warnings:
- Handle all specimens as if capable of transmitting HIV or hepatitis. Always wear protective clothing when handling specimens.
- Always work under strict hygienic conditions (ISO 5 environment, e.g. LAF-bench) to avoid possible contamination.
- Only for the intended use
- Do not use the product if bottle, seal of the container or package is opened or defective when the product is delivered.
- The concentration of the xanthine derivative Theophylline leads to the occasional formation of precipitate at 2-8°C storage temperature. It is dissolved completely when warmed at 37°C (within 24 h) and does not compromise function and safety of the product.
- Do not use the product if it becomes discoloured, cloudy or shows any evidence of microbial contamination.
Storage instructions and stability:
- Shelf life is 6 months from time of manufacture.
- Store between 2-8°C.
- Do not freeze before use.
- Keep away from (sun)light.
- The product can be used safely up to 7 days after opening, when sterile conditions are maintained and the products are stored at 2-8°C.
- Do not use after expiry date.
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