GM501 Mineral Oil

Composition:
Mineral oil (Paraffin oil) (CAS code: 8042-47-5, EP Monograph: 0240)

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 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: 0.83 – 0.86 g/ml

Viscosity: < 30 cP at 30 °C

Sterility test by the current Ph. Eur. 2.6.1 / USP <71>: No growth

Endotoxin test by Limulus Amebocyte Lysate (LAL) methodology (USP <85>): < 0.1 EU/ml

One-cell Mouse Embryo Assay (blastocysts after 120 h in standard mouse IVF medium covered with test item): ≥ 80%

Peroxide Value (POV): < 0.1 mEq/kg

Use of pharmaceutical grade mineral (paraffin) oil

Instruction for use:

• GM501 Mineral Oil is a pre-washed ready-to-use oil, so no further preparations are necessary.
• 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:

• All human, organic material should be considered potentially infectious. Handle all specimens as if capable of transmitting HIV or hepatitis.
• Always wear protective clothing when handling specimens.
• Aseptic technique must be used to avoid possible contamination.
• 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 preequilibrated by putting it back in the incubator for several hours. If it does not disappear discard the product.
• Only for the intended use.
• Any serious incident (as defined in European Medical Device Regulation 2017/745) that has occurred must be reported to Gynemed and, if applicable, the Competent Authority of the EU Member State in which the user and/or patient is established.

Warning before use:

• Do not use the product if it becomes discolored, cloudy, or shows any evidence of microbial contamination.
• Do not use the product if seal of the container is opened or defective when the product is delivered.
• Do not use the product if the expiry date has been exceeded.
• Do not freeze before use.
• Do not re-sterilize after opening.
• Keep in its original packaging until the day of use.

Storage and disposal instructions:

• The shelf life is 18 months from time of manufacture.
• Store at 15-25°C. Storage temperature of 2-15°C is also possible. This might cause some turbidity which disappears when the oil is warmed.
• Keep away from (sun)light and avoid exposure to sources of irradiation.
• The product can be used safely for up to 28 days after opening the container if sterile conditions are maintained, and the products are stored at room temperature.
• Stable after transport (max. 5 days) at elevated temperatures (≤ 37°C).
• The device needs to be disposed in accordance with local regulations for disposal of medical devices.