ARTSMedia in Vitro Culture Medium

AM-IVC Medium with Human Serum Albumin

This medium was developed through a unique combination of expertise from the scientists Lotte Stroebech, CEO, Doctor of Veterinary Medicine, PhD and Claus Yding Andersen, MSc, Doctor of Medical Science. Lotte has more than 20 years of media making experience including with Origio.

ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a culture medium intended for in vitro fertilization and in vitro culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer.

Device Description

10 ml glass bottles, single packed, provided sterile.

ARTSMedia Culture Medium is a bicarbonate-buffered balanced salt solution, with Physiological Salt, Amino Acids, Calcium Lactate Pentahydrate, EDTA, Gentamicin Sulphate 10 μg/ml, Glucose, L-glutamine, Human Serum Albumin (HSA), Insulin, Sodium Hyaluronate, Sodium Pyruvate, Sodium Bicarbonate, and Phenol Red.

Quality Control Specifications

• pH:7,2 – 7,45 (Ph Eur. 2.2.3, USP <791>)
• Osmolality: 265-275 mOsm/kg (Ph Eur. 2.2.35, USP <785>)
• Sterility: No growth (Ph Eur. 2.6.1, USP<71>)
• Endotoxins: < 0.05 EU/ml (USP <85>)
• 1-cell Mouse Embryo Assay (MEA) ≥ 80% blastocysts by 96h.

The results of each batch are stated on Certificate of Analysis, which is available at www.artsmediadenmark.com

Regulatory

USA: FDA 510(k) NO: K220715

Storage

Store dark at 2-8°C in original container. Do not freeze.

General notes before use

AM-IVC Medium is bicarbonate buffered and should pre-equilibrate in a CO₂ incubator set at 37°C and 5-6% CO2. Note: Adjust incubator settings to a higher CO₂ concentration if the altitude is above sea level.

To maintain pH, temperature, and osmolality, make sure that the medium is completely covered with oil.

Component List

Physiological salts
Potassium chloride
Magnesium Sulfate
Potassium phosphate monobasic, anhydrous
Magnesium Chloride
Sodium Chloride
Calcium chloride
Synthetic Serum Replacements
Sodium Bicarbonate
Human Insulin Recombinant
Sodium selenite
Ethanolamin
EDTA
EDTA FE3+ iron(III) sodium salt
Sodium citrate
Zink sulphate
Gentamicin
Glycine
L-aspartic Acid
Amino acids
Alanyl-L- glutamine
Vitamins
Myo Inositol
Calcium Lactate
Glucose
Sodium Pyruvate
HSA
Hyaluronic Acid
Phenol Red