ARTSMedia High Viscosity "Heavy" Oil
AM HV-Oil is intended for use in In Vitro Fertilization (IVF), Intracytoplasmic Sperm Injection (ICSI) and related Assisted reproductive technologies (ART) as overlay on media.
This oil is FDA approved and will shortly be released in the US.
Description
50 ml glass bottles, single packed, provided sterile. Peroxide tested pre-washed oil washed and ready-to-use mineral oils for use in human assisted reproductive techniques.
Oil viscosity influences temperature, pH and osmolarity, with higher viscosity demonstrating higher yields after overlay in embryo culture in terms of blastocyst formation rates and cell counts.
Advantages: easier to handle, droplets are maintained better, and oil doesn’t spill over as easy.
Temperature, pH is better maintained and increased media osmolarity is avoided both during handling and during culture.
The unit of viscosity is newton-second per square metre, which is usually expressed as pascal-second in SI units, cP.
Increased in viscosity from < 30 cP to 95-140 cP.
Quality Control: Strict quality control tests of each batch which besides a bovine embryo assay (BEA) test also includes
*) POV, sterility, and endotoxin tests.
*) The peroxide value (POV) is defined as the reactive oxygen contents expressed in terms of milliequivalents (meq) of free iodine per kilogramme of fat. It is determined by titrating iodine liberated from potassium iodide with sodium thiosulphate solution. Oils with POV well below 10 meq/kg are considered fresh – The limit for this oil is <0.1meq/kg
Quality Control Specifications
- Density: 0.86-0.88g/ml
- Viscosity: 95-140cP at 30 °C
- Endotoxin : < 0.1EU/ml USP <85>
- Peroxide Value (POV): < 0.1mEq/kg
- Sterility : No growth (Ph. Eur. 2.6.1, USP<71>)
- 1-Cell Mouse Embryo Assay: ≥ 80% blastocysts embryos developed to expanded blastocyst at 120 hours
The results of each batch are stated on Certificate of Analysis, which is available upon request.
Regulatory
USA: FDA 510(k) NO: K220715
Storage
Keep away from sunlight at 2-8° C in original container. Do not freeze.
The products can be used up to 1 month after opening, when sterile conditions are
maintained and the products are stored at room temperature. Stable after transport (max. 5 days) at elevated temperature (≤ 37 °C).
Key Ingredients
Pharmaceutical grade light mineral oil
*), pre-washed and sterile filtered light paraffin oil.
Oil is often the key to poor results, use only BEA tested and Peroxide Value (POV) tested oil as minimum standard quality control.
*) Liquid paraffin oil is a mineral oil and is a by-product of crude oil distillation.
General notes before use
The oil should be pre-warmed prior to use.
To maintain pH, temperature, and osmolality, make sure that the medium is completely covered with oil.
The oil should be used according to the established procedures and protocols optimized for the individual clinic.
