It can improve the stability of lipid nanoparticles and mRNA vaccine to prevent excessive lipid viscosity. Liposome preparations using sucrose as a lyophilization protectant have good post-reconstitution stability and efficacy. For example, Vyxeos, a marketed compound liposome of Cytarabine and Daunorubicin uses sucrose as a lyoprotectant.
NMPA CDE registration no.: F20200000093(A)
USFDA DMF no.: 035209
| Product Name | Sucrose (for injection) |
| Chemical Name | α-D-Glucopyranoside, β-D-fructofuranosyl-sucrose |
| CAS No. | 57-50-1 |
| NMPA CDE registration no. | F20200000093 |
| USFDA DMF No. | 035209 |
| Quality grade | injection |
| Quality standards | Conforms with USP, EP, JP, ChP standards |
| Molecular Formula | C12H22O11 |
| Applications and examples | Liposome active drug loading novel excipient (Irinotecan liposome) |
| Product code | O09001 |
| Package sizes | 10kg |
| Storage condition | It is valid for three years when used and stored properly. |
Sucrose low endotoxin has a FDA DMF Number of 35209 and a CDE Record registration Number of F20200000093.
Low endotoxin sucrose is produced in an aseptic GMP environment and has an endotoxin level of less than 0.5 IU/g. It is suitable for injection purposes. The inclusion of low endotoxin trehalose dihydrate excipient in the formulation enhances the stability of biological molecules and minimizes the risk of adverse reactions in patients.
Can be used for antibodies, liposomes, vaccines and other biologics(e.g. mRNA-1273®, BNT162b2®, Enbrel®).
If you have any questions, please don't hesitate to contact us. We're always here to help with Pharmaceutical Excipients for your business. We can provide products ranging from grams to tons. AVT is able to produce and even register the product in US FDA according to your special needs.
