HIGH PURITY, LOW ENDOTOXIN EXCIPIENTS
Brand ofPfanstiehl
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.
Grades
S-124-2-MC
Grades
S-124-2-MC
Pharmacopeial Names
Sucrose, low endotoxin, USP/NF, EP, JP, ChP, Beet derived
Applications
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
PDS
SDS
Grades
S-124-1-MC
Grades
S-124-1-MC
Pharmacopeial Names
Sucrose, low endotoxin, USP/NF, EP, JP, ChP, Cane derived
Applications
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
PDS
SDS
Grades
T-104-4
Grades
T-104-4
Pharmacopeial Names
Trehalose Dihydrate, low endotoxin, USP/NF, EP, JP, ChP 
Applications
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
PDS
SDS
Grades
M-167
Grades
M-167
Pharmacopeial Names
Maltose hydrate, low endotoxin USP/NF
Applications
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
PDS
SDS
Grades
D-161
Grades
D-161
Pharmacopeial Names
Sodium succinate hexahydrate, low endotoxin, USP/NF
Applications
Biopharmaceutical ingredient for pH buffering and final product formulation (e.g. Antibody Drug Conjugates)
PDS
SDS
Grades
T-153
Grades
T-153
Pharmacopeial Names
Tris base, low endotoxin, USP/NF, EP, JP, ChP,
Applications
Biopharmaceutical ingredient for pH buffering and final product formulation (e.g. Antibody Drug Conjugates)
PDS
SDS
Grades
T-154
Grades
T-154
Pharmacopeial Names
Tris HCl, low endotoxin
Applications
Biopharmaceutical ingredient for pH buffering and final product formulation (e.g. Antibody Drug Conjugates)
PDS
SDS
Grades
G-126-3
Grades
G-126-3
Pharmacopeial Names
D-Galactose, low endotoxin, EP
Applications
Used in biopharmaceutical applications as a key component to ensure consistency of therapeutic glycosylation, potency, and yield
PDS
SDS
Grades
M-164-2
Grades
M-164-2
Pharmacopeial Names
D-Mannose
Applications
Cell culture media additive to which serves as an energy source, precursor for synthesis of proteins, maintains osmotic balance and functions in cell signaling
PDS
SDS
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