January. 25, 2023

We posted an article about N-nitrosoamine risk assessments for oral dosage forms.

CeolusTM demonstrated a very low level of nitrite and nitrate that can allow mitigating nitrosamine formation in the drug products with secondary or tertiary amines.
Obtained results justified with Asahi Kasei Corp.’s manufacturing process features allow to do the evidence-based choice of MCC-grades with low nitrite content for the formulation of oral dosage form formulations with low nitrosamine-associated risk.

N-nitrosamine risk assessments for oral dosage forms: Nitrite content in the microcrystalline cellulose (MCC)

The full article is available Pharmaexcipients website.