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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

Endotoxin Limit (EU/g)

Applications

S-124-2-MC

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

≤ 0.2

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

≤ 0.3

G-126-2

D-Galactose, low endotoxin 

≤ 2

G-126-3

D-Galactose, low endotoxin, low metal EP

≤ 1

M-132-1

Maltose hydrate, low endotoxin USP/NF

≤ 1.0

T-104-4

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

≤ 0.3

M-164-2

D-Mannose, low endotoxin, low metal 

≤ 10

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

≤ 1.0 Stabilizes proteins against aggregation, buffering agent in biopharmaceutical and pharmaceutical formulations

A-171

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

≤ 2.0
D-160

Sodium succinate anhydrous, low endotoxin, USP/NF

≤ 2.0

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

D-161

Sodium succinate hexahydrate, low endotoxin, USP/NF

≤ 2.0
H-116

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

≤ 2.0

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

≤ 2.0


 

 

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