Raw material powder Citicoline Sodium, a nucleotide derivative, is prepared from 5'- Cytidylic acid and choline phosphate, which is an important intermediate product of lecithin biosynthesis. It is mainly used to treat the sequelae of the nervous system caused by craniocerebral injury and cerebrovascular accidents in clinics. It was first developed successfully by Takeda Pharmaceutical Industry Company of Japan in the 1960s, and registered in China in 1988. As we all know, the differences in impurity content, bioavailability, and side effects between generic drugs and original drugs will lead to differences in clinical safety and effectiveness, thus affecting their drug safety. The 12th Five-Year Plan for National Drug Safety also clearly stated that the quality of generic drugs should be comprehensively improved, and the generic drugs before the implementation of the revised Administrative Measures on Drug Registration in 2007 should be comprehensively compared with the generic drugs by stages and in batches, so that generic drugs and generic drugs can reach an agreement. At present, the consistency evaluation of generic drugs is mainly aimed at preparations, but as an important part of preparations, the properties of APIs are closely related to the quality, stability, and efficacy of pharmaceutical preparations, and the consistency evaluation of APIs can not be ignored. With the registration of Citicoline Sodium in China, many companies have invested in the research and development of Citicoline Sodium. At present, there are hundreds of enterprises producing Citicoline Sodium preparations in China.
It is a central nervous excitant, which can effectively improve the function of the central nervous system and promote the redox process of cells.
The Ministry of Health uses ultraviolet spectrophotometry to determine the content of Citicoline Sodium at 280nm. However, a large number of documents report that the related substances produced during its synthesis and storage have ultraviolet absorption at 280nm, and a large number of auxiliary materials are added in the preparation process, so the original method cannot effectively control the product quality, while the high-performance liquid phase method has the characteristics of strong specificity and high sensitivity.
|
|
| Real shot pictures of Citicoline Sodium powder | Citicoline Sodium structure diagram |
Product Application
1. Raw material powder Citicoline Sodium is used for acute craniocerebral trauma and disturbance of consciousness after brain surgery, and can gradually restore the function of limbs for hemiplegia caused by stroke.
2. It is used for other functional and conscious disorders caused by acute injury of the central nervous system,
3. It is used for ischemic cerebrovascular disease and vascular dementia.
4. It is used for acute craniocerebral trauma and consciousness disorder after brain surgery.
5. It is used to increase cerebral blood flow, promote cerebral metabolism and improve cerebral circulation.
6. It is used to treat the sequelae of the nervous system caused by craniocerebral injury or cerebrovascular accident.
Product Specification
Item | Specification | Results |
Description | A white or almost white crystalline powder, odorless | Complies |
Identification | 1) Chemical reaction | Positive reaction |
pH | 6.0 - 7.5 | 6.6 |
Clarity, color | Clear, colorless | Complies |
Related substances | 5'-CMP ≤0.30% | 0.01% |
Single impurity ≤0.20% | 0.02% | |
Total Impurity ≤0.70% | 0.05% | |
Residual solvents | Limit of methanol≤0.30% | Undetected |
Limit of ethanol ≤0.50% | 0.015% | |
Limit of acetone ≤0.50% | Undetected | |
Limit of chloride | ≤0.05% | 0.02% |
Limit of ammonium salt | ≤0.05% | 0.01% |
Limit of iron salt | ≤0.01% | 0.008% |
Limit of phosphate | ≤0.1% | 0.06% |
Limit arsenic salt | ≤0.0001% | 0.0001% |
Loss on drying | ≤6.0% | 1.0% |
Heavy Metals | ≤5ppm | Complies |
Endotoxin | ≤0.30 EU/mg | Complies |
Limit of microbe | Total bacterial count W 800 CFU/g Yeast & MoldW80 CFU/g E. Coli: Negative | lOCFU/g <10CFU/g Undetected |
Assay(HPLC) | 99.00% | 99.78% |
Send your Inquiry for more details, Click email：allen@faithfulbio.com Now.
You can also contact me via WhatsApp：+86 13137770562
A variety of shipping methods for you to choose
Transportation Time | Shipping method | Cargo weight requirements | Advantage |
3-7 days | DHL,Germany DHL,Germany DPD, | Suitable for under 50kg. | We have warehouses in Germany and California, USA, |
7-15 days | By Air | Suitable for more than 50kg. | |
15-60 days | By Sea | Suitable for more than 500kg. |
Disclaimer: The articles published on this site are mainly used to promote academic exchanges and learning, and do not mean that this site agrees with its views or confirms the authenticity of its contents. Please filter carefully. If you believe this article is infringing, please contact the administrator. We are not responsible for the consequences of using the information and services on this website.
Note: This compound should be used for research purposes only. These claims have not been evaluated by the Food and Drug Administration. Please consult your doctor and learn about available studies before using them. This product is not intended to diagnose, treat, cure or prevent any disease.
Hot Tags: raw material powder citicoline sodium cas 33818-15-4, China, suppliers, manufacturers, factory, customized, wholesale, buy, price, bulk, pure, producer, discount, for sale, in stock, free sample, raw powder, raw material, made in China