规格或纯度 | 医药级 | ||||||||||||||||||||||||||||||||||||||
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英文名称 | 10×BsaI Reaction Buffer | ||||||||||||||||||||||||||||||||||||||
储存温度 | -20°C储存 | ||||||||||||||||||||||||||||||||||||||
运输条件 | 超低温冰袋运输 | ||||||||||||||||||||||||||||||||||||||
产品介绍 |
产品描述 10×BsaI Reaction Buffer, GMP Grade 是限制性核酸内切酶 BsaI(货号B406392)的配套反应缓冲液。配方为 100mM Tris-HCl (pH 7.5), 100mM MgCl2 , 500mM NaCl, 1mg/mL HSA。? 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
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。 ? 产品特点 本产品用于限制性核酸内切酶 BsaI 的酶切反应,为其提供合适的反应条件。酶切反应可在 1-16h 内完成,可根据实验安排 选择反应时间,酶切快速且特异性好。 保存温度 -20±5 ℃。 注意事项 BsaI对某些甲基化修饰敏感,使用时注意酶切底物无BsaI敏感的甲基化修饰(具体的甲基化敏感信息见04/产品特点)。 酶切后产物若作为体外转录模板,建议纯化后使用。 ? Product Description ten × Bsai reaction buffer, GMP grade is the supporting reaction buffer of restriction endonuclease bsai (Article No.:B406392). The formula is 100 mm Tris HCl (pH 7.5), 100 mM MgCl2 , 500 mM NaCl, 1 mg / ml HSA. This product is produced with medicinal raw and auxiliary materials, and all kinds of pollution in the production process are strictly controlled. It complies with the product production and quality management procedures of GMP, so as to ensure the traceability of the production process and all raw and auxiliary materials. Quality requirements
Follow 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 are used as excipients in cell therapy, gene therapy and tissue engineering 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 medical products. Product features This product is used for restriction endonuclease bsai digestion reaction to provide appropriate reaction conditions. The enzyme digestion reaction can be completed within 1-16h. The reaction time can be selected according to the experimental arrangement. The enzyme digestion is fast and has good specificity. Storage temperature -20±5 ℃。 Precautions BsaI is sensitive to some methylation modifications. When using it, pay attention to the substrates without BsaI-sensitive methylation modifications (see 04/Product Features for specific methylation sensitivity information). If the digested product is used as a template for in vitro transcription, it is recommended to use it after purification. |