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HIGH PURITY, LOW ENDOTOXIN EXCIPIENTS

Brand of

D-Galactose, Low endotoxin

These ultra-pure, low-endotoxin range of products derived from botanical sources is purified through a combination of various techniques including chromatography, de-ionization, ultrafiltration, nanofiltration, activated carbon treatment and re-crystallization. The key advantages of these products are lot-to-lot consistency, low reducing sugar content and chemical and microbial purity. These excipients are used for biologics, biosimilars, vaccines, cell-culture media and injectable (liquid and lyophilized) formulations.
Pharmacopeial Names Compositions Applications
Sucrose, low endotoxin, USP/NF, EP, JP, ChP, Beet derived As carrying agents and lyoprotectants in parenteral formulations, particularly intravenous and intramuscular injectables For blood protein fractionation products Also used in biopharmaceutical applications as protein stabilizers, bioprocessing components and supplements
Sucrose, low endotoxin, USP/NF, EP, JP, ChP, Cane derived As carrying agents and lyoprotectants in parenteral formulations, particularly intravenous and intramuscular injectables For blood protein fractionation products Also used in biopharmaceutical applications as protein stabilizers, bioprocessing components and supplements
Trehalose Dihydrate, low endotoxin, USP/NF, EP, JP, ChP  As carrying agents and lyoprotectants in parenteral formulations, particularly intravenous and intramuscular injectables For blood protein fractionation products Also used in biopharmaceutical applications as protein stabilizers, bioprocessing components and supplements
Maltose hydrate, low endotoxin USP/NF As carrying agents and lyoprotectants in parenteral formulations, particularly intravenous and intramuscular injectables For blood protein fractionation products Also used in biopharmaceutical applications as protein stabilizers, bioprocessing components and supplements
Sodium succinate hexahydrate, low endotoxin, USP/NF Biopharmaceutical ingredient for pH buffering and final product formulation (e.g. Antibody Drug Conjugates)
Tris base, low endotoxin, USP/NF, EP, JP, ChP, Biopharmaceutical ingredient for pH buffering and final product formulation (e.g. Antibody Drug Conjugates)
Tris HCl, low endotoxin Biopharmaceutical ingredient for pH buffering and final product formulation (e.g. Antibody Drug Conjugates)
D-Galactose, low endotoxin, EP Used in biopharmaceutical applications as a key component to ensure consistency of therapeutic glycosylation, potency, and yield
D-Mannose Cell culture media additive to which serves as an energy source, precursor for synthesis of proteins, maintains osmotic balance and functions in cell signaling

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