CTP, cytidine-5'-triphosphate in Chinese, can be used in a variety of related applications in molecular biology, such as in vitro transcription, RNA amplification, and the synthesis of choline and ethanolamine. This product is CTP sodium salt solution with purity ≥ 99% (HPLC), the concentration is 100mm ± 5mm, and there is no endonuclease, exonuclease and ribonuclease pollution.
This product is produced with raw and auxiliary materials of medicinal specifications, and all kinds of pollution in the production process are strictly controlled. The product production and quality management procedures in line with GMP specifications ensure the traceability of the production process and all raw and auxiliary materials.
Quality requirement
| project |
standard |
| appearance |
Clear liquid |
| Visible foreign matter |
Compliance with regulations |
| PH value |
6.5-7.5 |
| concentration |
100mM±5mM |
| purity |
≥ 99%
|
| A250/a260 UV absorption ratio |
0.84±0.02 |
| A280/a260 UV absorption ratio |
0.97±0.02 |
| λ Max UV maximum absorption peak |
271nm±2nm |
| Functional test |
RNA mass production ≥ 100 μ g |
| RNase residue |
The degradation of substrate shall not exceed 10% |
| Endonuclease residue |
The degradation of substrate shall not exceed 10% |
| Exonuclease residue |
The degradation of substrate shall not exceed 10% |
|
Follow the following specifications for production
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 Committee.
4. USP chapter <1043>, excipients 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 medical products.
Storage temperature
The product can be stored or transported at -20 ± 5 ℃ for a short time, and stored at -70 ± 5 ℃ for a long time. The product is valid for 1 years;
Avoid multiple freeze-thaw cycles and frequent temperature changes;
The product may form a concentration gradient after freezing, and it needs to be fully mixed before use.
C2604407