|Product Name||D(+)-Trehalose Dihydrate (For Injection)(Sterile)|
|Chemical Name||α-D-glucopyranosyl-α-D-glucopyranoside dihydrate|
|EINECS Registration Number||202-739-6|
|CDE Record Registration Number||F20190000452|
|FDA DMF Number||34401|
|Grade||Pharmaceutical injection grade|
|Quality Standards||in line with national pharmacopeia standards (Chp, USP, JP, EP)|
|Available Package Sizes||3kg,10kg|
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®).
Low hygroscopicity and water retention.
Heat resistant, acid resistant and extremely stable.
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.