GM501 Basic
GM501 Basic is a bicarbonate buffered cell culture medium, designed for fertilisation and for all embryo culture from day 1 to blastocyst stage. It can also be used for embryo transfer.
Addition of human albumin solution (1 %) by the customer is required for optimal culture conditions.
Rev01_00
| Product description | Product code | Unit |
|---|---|---|
| GM501 Basic | 4 GM501-20 | 20 ml |
| GM501 Basic | 4 GM501-50 | 50 ml |
| GM501 Basic | 4 GM501-100 | 100 ml |
| GM501 Basic | 4 GM501-250 | 250 ml |
| GM501 Basic | 4 GM501-500 | 500 ml |
Product facts and notices
- Composition
- Product specifications and quality control
- Instructions for use
- Precautions and warnings
- Storage instructions and stability
Composition:
- NaCl, KCl, KH2PO4, MgSO4.7H2O, NaHCO3, CaCl2.2H2O, D(+)-Glucose anhydrous, Na-Lactate (50 % solution), Na-Pyruvate, EDTA, Na-Alanyl-Glutamine, water, non-essential and essential Amino Acids.
Produktspezifikationen und Qualitätskontrolle:
- 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 Basic is available upon request and can also be downloaded from our website.
- GM501 Basic is manufactured and tested according to the following specifications:
| pH (at 37°C, 6 % CO2) | 7.20-7.40 |
| Osmolality (mOsm/kg) | 270-290 |
| Sterility | sterile – SAL 10-3 (Sterility Assurance Level) |
| Endotoxins (EU/ml) | < 0.25 |
| MEA (Blastocysts after 96h in %) | ≥ 80 after 30 min of exposure (zygote stage) |
Instructions for use:
- The intended users are IVF professionals (lab technicians, embryologists or medical doctors).
Addition of human albumin solution before use (preparation of work solution).
- GM501 Basic must be supplemented with Human Albumin Solution to a protein end concentration of 1 % (w/v). The use of 4 HSA-0005 (Gynemed) is strongly recommended. To supplement the 50 ml unit, keep 45 ml medium in the bottle and add 5 ml of 4 HSA-0005. Mix well.
- Embryo culture media must be equilibrated over night in a humidified CO2-incubator (at 5-7 % CO2, 37°C).
- GM501 Basic is designed for embryo culture under oil as well as in open systems.
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 (ISO 5 environment, e.g. LAF-bench) to avoid possible contamination.
- Only for the intended use.
Pre-use checks:
- Do not use the product if bottle, seal of the container or package is opened or defect 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 6 months from time of manufacture.
- Store between 2-8°C.
- Do not freeze before use.
- Keep away from (sun) light.
- The product can be used safely up to 7 days after opening, when sterile conditions are maintained.
- Do not use after expiry date.