GM501 Hyaluronidase is a ready-to-use solution designed to facilitate the mechanical removal of cumulus cells. Hyaluronidase digests the extracellular matrix in the cumulus-oocyte complex consisting of hyaluronic acid.
| Product description |
Product code |
Unit |
| GM501 Hyaluronidase | FGY4HY0010 | 10 ml |
| GM501 Hyaluronidase | FGY4HY001-5 | 5 x 1 ml |
Product facts and notices
Composition
- 80 IU/ml pharmaceutical grade hyaluronidase from bovine origin solved in HEPES-buffered medium, containing 4.00 g/liter human serum albumin.
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 Hyaluronidase is available upon request and can also be downloaded from our website.
- GM501 Hyaluronidase is manufactured and tested according to the following specifications:
| pH (at 37°C) | 7.30-7.60 |
| Osmolality (mOsm/kg) | 270-290 |
| Sterility | sterile – SAL 10-3 (Sterility Assurance Level) |
| Endotoxins (EU/ml) | < 1.00 |
| MEA (1-cell assay, blastocysts after 96h in %) |
≥ 80 |
Precautions and warnings:
- Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot totally be excluded. This also applies to unknown or emerging viruses and other pathogens. There are no reports of proven virus transmissions with albumin, manufactured to European Pharmacopoeia specifications by established processes.
- Handle all specimens as if capable of transmitting HIV or hepatitis. Always wear protective clothing when handling specimens.
- Product does not contain any antibiotics. Always work under strict hygienic conditions (e.g. LAF-bench, ISO Class 5) 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.
Bovine sourced Hyaluronidase:
- The Pharmaceutical grade hyaluronidase used in this product is sourced from bovine testis. It is certified not to contain any neuronal tissue (Certificate of Suitability/ CEP).
- Hyaluronidase is sourced from animals determined „fit for human consumption“ and originating from countries with „negligible BSE risk“ (Resolution No. 18 „Recognition of the Bovine Spongiform Encephalopathy Risk Status of Member Countries (2014)“, adopted by the OIE).
- According to the „WHO guideline on Transmissible Spongiform Encephalopathies in Relation to Biological and Pharmaceutical Product“, and according to EC directive 2004/C24/03 „Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01) adopted by the Committee for Proprietary Medicinal Products (CPMP) and by the Committee for Proprietary Medicinal Products (CVMP)“, testis material from bovine source is classified as a „Category C: Tissues with no detected infectivity“ product.
