Reducing the risk of nitrosamine formation in pharmaceuticals
Microcrystalline cellulose MCC is one of the most frequently used binders/fillers/diluents in oral solid dosage forms. This means that there is usually a much higher concentration of MCC present in a formulation compared with other excipients. If the MCC used has a high nitrite content, it can be posing a significant risk for nitrosamine formation.
CEOLUS™ MCC grades from Asahi Kasei display an exceptionally low level of nitrite and nitrate due to specific manufacturing process features. Low nitrite and nitrate content in CEOLUS™ MCC is secured by not using any of the following substances in the manufacturing process: secondary and tertiary amines, quaternary ammonium salts, amide solvents, sodium nitrite esters or nitrite, reagents or catalysts. By using CEOLUS™ MCC, it is therefore possible to lower the nitrosamine-associated risk in pharmaceutical formulations.
The low nitrite CEOLUS™ MCC is available in the following grades:
- CEOLUS™ KG – Highly compactible MCC with fibrous particles
- CEOLUS™ UF – Porous MCC with balance of compactibility and flowability
- CEOLUS™ PH – Standard grade with high quality
All grades comply with USP/NF, Ph.EUR., JP.
Learn more about our range of MCC: High performance MCC with special functionalities >
