The registration number (F20200000093) of AVT sucrose (for injection) has been published recently. It can be inquired through the entrance of "Registration Information Disclosure of APIs, Excipients and Packaging Materials" on the CDE official website. The following is a screenshot of the query results.
AVT sucrose has the characteristics of low endotoxin (measured value <0.5IU/g) and high quality, which can meet the development needs of various grades of products; registration number (F20200000093), DMF number: 035209, help customers to declare products in China and abroad (in line with national pharmacopoeia standards Chp, USP,JP,EP);
AVT sucrose has an ultra-high cost performance, which improves the competitive advantage of customer preparation products. If you need products, please feel free to contact us.
What kind of pharmaceutical excipient product is AVT low endotoxin sucrose?
Product name: Sucrose (for injection)
Chemical name: D-(+)-Saccharose, Α-D-glucopyranoside-B-D-fructofuranoside
CAS number: 57-50-1
Registration number: F20200000093
DMF number: 035209
Manufacturer: AVT (Shanghai) Pharmaceutical Tech Co., Ltd.
Grade: pharmaceutical injection grade excipients
Molecular formula: C12H22O11
Molecular weight: 342.3
Uses: freeze-dried protective agent, cryogenic protective agent
Storage: Transported under normal temperature, sealed, kept in a cool and dry place
How is low endotoxin sucrose prepared?
Sucrose is almost universally present in the leaves, flowers, stems, seeds and fruits of the plant kingdom. The content in sugar cane and sugar beet is particularly rich. Therefore, modern sucrose production basically uses these two plants as raw materials, of which sugar cane raw material sucrose accounts for about 70%. Sucrose has a sweet taste and high edible value. It originated in ancient India and was introduced to China through the Silk Road. After thousands of years of historical development, the refining technology has been continuously improved, from the earliest "stone honey" to brown sugar.To high-purity white granulated sugar, now it has the ability to produce injection-grade sucrose.
The production process of sucrose is roughly divided into several steps: raw material → juice extraction → clarification → evaporation → boiling and crystallization → honey separation → drying → sieving → packaging. As the name suggests, juice extraction is to squeeze cleaned and crushed sugarcane or sugar beet to obtain raw juice containing sucrose and a large amount of impurities.Clarification is an important step in the sugar process. A very important clarifying agent in the process is lime milk, which can precipitate acidic substances in the juice. In addition, depending on the process, clarification media such as sulfur dioxide, carbon dioxide, and phosphoric acid may also be used . Due to the harm of sulfur to human health, some countries adopt membrane filtration and ion exchange technology in the production process of cane sugar industry. The products do not contain sulfur and are highly competitive in the international market.
The edible-grade sucrose is further purified to obtain pharmaceutical-grade sucrose products.
Why is low endotoxin sucrose used so much?
Sucrose is a non-reducing disaccharide, which is formed by the condensation and dehydration of the hemiacetal hydroxyl of a molecule of glucose and the hemiacetal hydroxyl of a molecule of fructose. The sucrose products provided by AVT are high-purity and low-endotoxin injection-grade medicinal sucrose, which is often used as a freeze-dried protective agent in the field of pharmacy in nano-preparations and protein biological products. It not only acts as a cryoprotectant in the process of freeze-drying, but also as a dehydration protective agent in drying and dehydration, and can also adjust osmotic pressure. It is recognized as one of the most widely used and best-effective freeze-drying protective agents.
If you are interested in AVT low endotoxin sucrose, welcome to call us at 400-6262 623!