GM501 Mineral Oil is a ready-to-use oil for covering the medium during IVF/ICSI treatment. GM501 Mineral Oil protects the medium from evaporation and thereby stabilizes pH and temperature.

GM501 Mineral Oil spec. sheet

Applications for the Gynemed MediaLine

 

Product description
Product code
Unit
GM501 Mineral Oil FGY4MO0100 100 ml
GM501 Mineral Oil FGY4MO0500 500 ml

 

Product facts and notices

Composition

Mineral Oil

  • CAS code: 8042-47-5
  • EP Monograph: 0240

General Information:

  • GM501 Mineral Oil (density 0.83 – 0.86 g/ml) is pre-washed twice with ultra-pure water.
  • GM501 Mineral Oil has to be pre-incubated for 5 hours with the lid closed at 37°C

Product specifications and quality control

  • Pharmaceutical grade mineral (paraffin) oil.
  • A certificate of analysis is available for each batch upon request from our website with respective lot number.The MSDS for GM501 Mineral Oil is available upon request and can also be downloaded from our website.
  • GM501 Mineral Oil is manufactured according to the following specifications:

Density (g/ml): 0.83-0.86


Viscosity (bei 30°C/cp): < 30


Sterility: sterile – SAL 10-3 (Sterility Assurance Level)


Endotoxins (EU/ml): < 0.10


MEA (Blastocysts after 120 h in culture in %): ≥ 80


Peroxide Value (POV): < 0.1 mEq/kg

 

Instructions for use:

  • GM501 Mineral Oil is a pre-washed ready-to-use oil, so no further preparations are necessary.
  • After pre-incubation (5 hours/37°C) overlay the culture medium with GM501 Mineral Oil until it is completely covered.
  • We recommend preparing the dishes with oil overlay the day before use. If using bicarbonate buffered media incubate the dishes in a CO2 incubator at 37°C to ensure warming and saturation with gas.
  • Any procedures described herein are recommendations only. Each laboratory needs to establish and validate its own procedures for medium preparation and use.

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 (e.g. LAF-bench ISO Class 5) to avoid possible contamination.
  • Only for the intended use.
  • The oil may appear cloudy if removed from the incubator and allowed to stand at room temperature for extended periods of time. Such cloudiness usually disappears if the oil is re-equilibrated by replacing it in the incubator for several hours, if it does not disappear discard the product.
  • The user facility of this device is responsible for maintaining traceability of the product and must comply with national regulations regarding traceability, where applicable.

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:

  • The shelf life is 18 months from time of manufacture.
  • Store between 15-25°C. Storage temperature between 2-15°C is also possible. This might cause some turbidity which disappears when the oil is warmed.
  • Keep the product in the original packaging or shield from light while not in use.
  • Do not freeze before use.
  • Keep away from (sun) light.
  • Avoid exposure to sources of irradiation.
  • The product can be used safely for at least 28 days after opening the container when sterile conditions are maintained and the products are stored at room temperature.
  • Stable after transport (max. 5 days) at elevated temperatures ­ (≤ 37°C)
  • Do not use after expiry date.
  • Cannot be resterilized after opening.