S-(5′-Adenosyl)-L-methionine (SAM, AdoMet) with an activating methyl group is a vaccinia virus capping enzyme (GMP-M062) and mRNA Cap 2’-O methyltransferase (GMP-M072) catalyzed methylation methyl donor, the storage buffer formula is: 0.005M Sulfuric Acid, 10% ETOH.
This product is produced with raw and auxiliary materials of pharmaceutical specifications, and all kinds of pollution in the production process are strictly controlled. Product production and quality management procedures in line with GMP standards ensure the traceability of the production process and all raw and auxiliary materials.
Quality requirements
| project |
standard |
| appearance |
Clear liquid |
| Visible foreign matter |
Compliance with regulations |
| purity |
≥96% |
| Endonuclease residues |
Degradation of substrate shall not exceed 10% |
| Exonuclease residues |
Degradation of substrate shall not exceed 10% |
| RNase residue |
Degradation of substrate shall not exceed 10% |
| Bacterial endotoxin content |
≤1EU/mg |
| Mycoplasma detection |
negative |
| Heavy metal residues |
≤10ppm |
|
Produced according to the following specifications
1. ISO 9001:2015, certified facility.
2. "GMP Appendix - Cell Therapy Products" State Drug Administration.
3. "General Introduction to Human Gene Therapy - Chinese Pharmacopoeia 2020" National Pharmacopoeia Commission.
4. USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
5. USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing
6. Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
Storage temperature
-20±5℃.
Precautions
1. SAM is unstable at pH 7–8, 37°C and needs to be freshly prepared before the reaction starts. The amount of SAM can be calculated in advance and aliquots of the 32 mM stock solution can be diluted to a working solution prior to the start of the reaction. To avoid SAM degradation, this working solution needs to be kept on ice.
A2329707