AVT (Shanghai) Pharmaceutical Tech Co., Ltd.
Formulation of Injection
Formulation of Injection PDF

Trehalose Dihydrate (for Injection) (Sterile)

Trehalose has been successfully applied in medicine as a stabilizer for blood products, vaccines, cell tissues and other bioactive substances, which can not only prolong the storage time at room temperature, but also prevent blood contamination. Also trehalose is widely used as a lyoprotectant in biological products. In addition, alginate is also a good choice as a lyoprotectant for liposomes.

NMPA CDE registration no.: F20190000452

USFDA DMF no.: 034401


PRODUCT DESCRIPTION

Product NameD(+)-Trehalose dihydrate(For Injection)(Sterile)
Chemical Nameα-D-glucopyranosyl-α-D-glucopyranoside dihydrate
CAS No.

6138-23-4

NMPA CDE registration no.F20190000452
USFDA DMF No.034401
Quality gradeInjection
Quality standardsConforms with USP, EP, JP, ChP standards
Molecular FormulaC12H22O11·2H2O
Applications and examplesBiological products, liposomes, vaccines, CAR-T, stem cells, diagnostic reagents, etc.
Product codeO08001
Package sizes10kg
Storage conditionStored in a cool, dark, and dry place, and transported at room temperature


Key Benefits of D(+)-Trehalose Dihydrate (For Injection)(Sterile)

  • FDA DMF NumberDMF: 34401; CDE Record registration Number: F20190000452.

  • Aseptic GMP production environment; low endotoxin (<0.1IU/g), injection grade.

  • Can be used in injectable formulations, recommended for CAR-T, stem cell products and other biologics with more stringent requirements on impurity content (e.g. Herceptin®).

D(+)-Trehalose Dihydrate (For Injection) (Sterile) Product Properties

Low hygroscopicity and water retention.

Heat resistant, acid resistant and extremely stable.

Have Any Questions?

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.

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