计算溶液所需的质量、体积或浓度。
PharmPure™,医药级 提供 ≥96% 纯度,适用于对基线干扰要求严格的色谱和分析工作流程。
-20°C储存。超低温运输 。请查阅批次 COA 获取详细规格。
SDS、COA、产品数据表及规格说明书均可下载。可通过批号查询获取批次 COA。
在色谱分析、有机合成和交叉偶联反应领域已被 0 篇同行评审文献引用。
S-(5′-腺苷)-L-甲硫氨酸(SAM,AdoMet)带有一个活化甲基,是牛痘病毒加帽酶(GMP-M062)和 mRNA Cap 2’-O 甲基转移酶(GMP-M072)催化甲基化的甲基供体,保存 buffer 配方为:0.005M Sulfuric Acid,10% ETOH。
本制品采用药用规格原辅料生产,并严格控制生产过程中各类污染等,符合 GMP 规范的产品生产与质量管理规程保障生产过程及所有原辅料可追溯。
质量要求
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遵循以下规范生产
1. ISO 9001:2015, certified facility。
2. 《GMP 附录-细胞治疗产品》国家药品监督管理局。
3. 《人用基因治疗总论-中国药典 2020》国家药典委。
4. USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products 用于细胞治疗,基因治疗和组织工程产品中的辅料。
5. USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing 细胞治疗产品生产过程中细胞因子和生长因子。
6. Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products 用于生产细胞或基因治疗药物的生物来源原料。
保存温度
-20±5 ℃。
注意事项
1. SAM 在 pH 7–8, 37°C 条件下不稳定,需要在反应开始之前新鲜配置。可以事先计算好 SAM 的用量,在反应开始前把分装 32 mM 的储备液稀释成工作液。为避免 SAM 降解,该工作液需要保存于冰上。
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
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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.
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| 批号(Lot Number) | 证书类型 | 货号 |
|---|---|---|
| 分析证书 | S427284 |