Trehalose Trehalose for injection 6138-23-4
The DMF number of the high-quality trehalose supplied by AVT has been officially announced. As a pharmaceutical excipient, AVT trehalose (Haibao 99-S) is super cost-effective and can meet the development needs of various high-end injections such as biological products, blood products and liposomes, especially the wide application of freeze-dried protective agents for biological products. Now it has obtained the registration number (F20190000452) and DMF number (34401), helping customers to declare their preparation products in China and abroad (in line with national pharmacopoeia standards Chp, USP, JP, EP)
Trehalose -AVT (Shanghai) Pharmaceutical Tech Co,. Ltd.
1、 Product name: Haibao 99-S
2、Common name:Trehalose (for injection) (sterile)
3、 English name: D(+)-Trehalose dihydrate (for injection)
4、 Chemical name: α-D-glucopyranosyl-α-D-glucopyranoside dihydrate
5、 Content determination: 99.3%
6、 CAS No. 6138-23-4
7、 EINECS registration No. 202-739-6
8、 Record registration No. F20190000452
9、 DMF No. 34401
10、 Quality standards: in line with national pharmacopoeia standards (Chp, USP, JP, EP)
11、 Molecular formula: C12H22O11·2H2O
12、 Molecular weight: 378.33
13、 Properties: white crystalline powder
14、 Specific rotation: +198.8°
15、 Acidity: 6.0
16、 Chloride: meet the regulations
17、 Sulfate: meet the regulations
18、 Soluble starch: in line with regulations
19、 Residue on ignition: 0.04%
20、 Heavy metals: in compliance with regulations
21、 Moisture: 9.5%
22、 Related substances: total impurities 0.06%, glucose not detected, maltotriose 0.06%, the largest unknown single impurities not detected
23、 Sterility: in compliance with regulations
24、 Microbial limit: sterile
25、 Bacterial endotoxin: <0.1IU/g
26、 Nitrogen: in line with regulations
27、 Determination of content: 99.3%
28、 Solubility: easily soluble in water, soluble in hot ethanol, slightly soluble in methanol, insoluble in ether and acetone
29、 Storage: sealed, stored in a cool, dark and dry place, and transported at room temperature
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