Mineral oil

Description / Use

PET bottle of 50 ml or 500 ml.

This mineral oil may be used for covering of tissue cultures in general, and more particularly for standard A.R.T. procedures (I.V.F., I.C.S.I., gamete and embryo cultures etc.).

Do not use:
- with single-use consumables sterilized by EtO (ethylene oxide)
- if the product or its packaging is damaged because product sterility and/or integrity would be compromised
- if liquid looks cloudy
- after the expiration date mentioned on the label

For external use only. Do not inject.

Store at a temperature between +2°C and +30°C (+36°F to +86°F) and protected from light.

Technical specifications

Appearance: clear colorless solution
Volume: 50 ml or 500 ml
Sterility: by filtration on 0.22µm cartridge
Shelf-life: 2 years from the date of manufacture in above-specified storage conditions (see expiration date mentioned on the label) / 7 days after opening.

Each batch of mineral oil is controlled to meet the following specifications:
Density: <0.875 at 20°C ± 2°C (68°F ± 3.6°F)
Viscosity: <50 mPa at 20°C ± 2°C (68°F ± 3.6°F)
Sterility: SAL 10-6
Mouse embryo test: >70% of blastocysts developed within 96 hours
Endotoxins: <0.25 IU/ml

All results are reported on a lot-specific Certificate of Analysis, which is available upon request.

Composition

This mineral oil mainly contains saturated aliphatic hydrocarbons and very small quantities of unsaturated aliphatic hydrocarbons.

Quality assurance

- Traceability: upstream and downstream traceability is ensured for both finished products and components, based on a computerized management system.
- Bottling is performed in a facility which complies with GMP directives.
- Quality of components: the mineral oil used complies with the European Pharmacopoeia, Vth Edition, 2005.
- Quality control: each batch of finished product is tested for its technical characteristics.

 

References

Description

Packaging

016558

Mineral oil
(bottle of 50 ml)

10

016559

Mineral oil
(bottle of 500 ml)

1