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HIGH PURITY, LOW-ENDOTOXIN EXCIPIENTS

This 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.

Product

Pharmacopoeial Name

Applications

S-124-2-MC

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

S-124-1-MC

Sucrose, low endotoxin, USP/NF, EP, JP, ChP, Cane derived

G-126-2

D-Galactose, low endotoxin 

G-126-3

D-Galactose, low endotoxin, low metal EP

M-132-1

Maltose hydrate, low endotoxin USP/NF

T-104-4

Trehalose Dihydrate, low endotoxin, USP/NF, EP, JP, ChP

M-164-2

D-Mannose, low endotoxin, low metal 

Used in biopharmaceutical applications as a key component to ensure consistency of therapeutic glycosylation, potency, and yield

A-170

L-Arginine, low endotoxin, low metal, USP/NF, EP, JP, ChP

Stabilizes proteins against aggregation, buffering agent in biopharmaceutical and pharmaceutical formulations

D-160

Sodium succinate anhydrous, low endotoxin, USP/NF

Biopharmaceutical ingredient for pH buffering and final product formulation (e.g. Antibody Drug Conjugates)

D-161

Sodium succinate hexahydrate, low endotoxin, USP/NF

H-116

L-Histidine, low endotoxin, low metal, USP/NF, EP, JP, ChP

Stabilizing and buffering agent in bioprocessing (upstream/downstream), biopharmaceutical and pharmaceutical formulations

H-117

L-Histidine hydrochloride monohydrate, low endotoxin, low metal, EP, JP, ChP

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