Nama produk | D( )-Trehalose dihydrate(Untuk suntikan) (steril) |
Nama kimia | Α-D-glucopyranosyl-α-D-glucopyranoside dihydrate |
CAS No. | 6138-23-4 |
NMPA CDE pendaftaran no. | F20190000452 |
USFDA DMF No. | 034401 |
Gred kualiti | Suntikan |
Piawaian kualiti | Mematuhi piawaian USP, EP, JP, ChP |
Formula molekul | C12H22O11· 2H2O |
Aplikasi dan contoh | Produk biologi, liposomes, vaksin, CAR-T, sel stem, reagen diagnostik, dll. |
Kod produk | O08001 |
Saiz pakej | 10kg |
Keadaan penyimpanan | Disimpan di tempat yang sejuk, gelap, dan kering, dan diangkut pada suhu bilik. |
FDA DMF NumberDMF: 35566; Nombor pendaftaran rekod CDE: F20200000284.
Persekitaran pengeluaran GMP aseptik, endotoxin rendah (<2.5IU/g), gred suntikan.
Digunakan secara meluas dalam agen biologi seperti ubat antibodi (contohnya Herceptin®).
AVT jenama trehalose dihydrate (untuk suntikan) biasanya digunakan sebagai lyoprotectants.
Penstabil dan cryoprotectant lipid tiny dan mRNA.
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