GM508 CultActive is a bicarbonate-buffer­ed reagent designed to investigate oocytes of patients with failed fertilization after previous Intracytoplasmatic Sperm Injection cycles.

GM508 CultActive is designed to investigate if fertilization failure after previous ICSI-cycles is due to a deficient oocyte activation.

 

Product description
Product code
Unit
CultActive FGY4GM508CULT-active 1 1 ml

 

Product facts and notices

Composition

  • 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, DMSO, Ca2+-Ionophore A23187.

Product specifications and quality control

  • All raw materials are of highest available purity (European Pharmacopoeia and/or USP standard) if applicable.
  • A certificate of analysis is available for each batch upon request from our website with respective lot number.
  • The MSDS for GM508 CultActive is available upon request and can be downloaded from our website.
  • GM508 CultActive is manufactured and tested according to the following specifications:
pH  (at 37°C, 6 % CO2) 7.00-7.60
Osmolality (mOsm/kg) 400-450
Sterility sterile – SAL 10-3 (Sterility Assurance Level)
Endotoxins (EU/ml) < 0.25
MEA (Blastocysts after 96 hours culture in %)

≥ 80

Instructions for use:

  • GM508 CultActive must be shaken directly before use for approximately 30 sec.
  • GM508 CultActive must be equilibrated 4 hours in a vial not firmly closed at 5-7 % CO2 and 37°C prior to use.
  • Equilibrate culture medium for washing (e.g. GM501 Cult) for 4 hours in a vial not firmly closed at 5-7 % CO2 and 37°C prior to use.
  • Prepare for each oocyte 1 drop (30 µl) GM508 CultActive and 2 drops (30-50 µl) MOPS- and HEPES-free culture medium, (e.g. GM501 Cult). An oil overlay is not necessary due to the short exposure time.
  • Immediately after the ICSI procedure incubate the oocytes for 15 minutes in the pre-equilibrated Ca2+-Ionophore GM508 CultActive drops. -Step 1
  • Remove the oocytes from the GM508 CultActive drop and wash them twice in culture media. This has to be done in a HEPES-or MOPS-free medium, e.g. GM501 Cult. -Step 2 and 3
  • Put the oocytes in your culture media for further culture.
  • Assess the development on specific time points.

Precautions and warnings:

  • Handle all specimens as if capable of transmitting HIV or hepatitis. Always wear protective clothing when handling specimens.
  • Product does not contain any antibiotics. Always work under strict hygienic conditions (e.g. LAF-bench, ISO Class 5) to avoid possible contamination.
  • Only for the intended use.

Pre-use checks:

  • Do not use the product if bottle, seal of the container or package is opened or defective when the product is delivered.
  • 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.