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D(+)-Trehalose Dihydrate (For Injection) (Sterile) CAS No.: 6138-23-4

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
EINECS Registration Number202-739-6
CDE Record Registration NumberF20190000452
FDA DMF Number34401
GradePharmaceutical injection grade
Quality Standardsin line with national pharmacopeia standards (Chp, USP, JP, EP)
Molecular FormulaC12H22O11·2H2O
Content Determination99.30%
Molecular Weight378.33
Product CodeO08001
Available Package Sizes3kg,10kg


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.

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