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Formulation and Delivery
Partner Presentation

Nitrite Assessment & Tablet Compression Characterization of Low-Nitrite MCC According to USP

Tuesday, October 22, 2024
3:30 PM – 4:30 PM MT
Location:360 Stage #4, Exhibit Hall

Sponsored By 

    Partner Presentation Speaker(s)

  • RM

    Raxit Mehta

    Technical Director
    Asahi Kasei America
    New York, New York

Description: Recent studies highlight that over 70% of drugs and their impurities could serve as a precursor to nitrosamine. Switching to low-nitrite excipients, such as microcrystalline cellulose (MCC), present a viable and successful approach to mitigate this risk. Low nitrite in MCC is particularly helpful considering higher concentration of MCC in the drug product formulation and proximity of MCC to the susceptible drug molecules. This presentation highlights low nitrite levels of Ceolus MCC along with assessing the tabletability, compressibility & compactibility of Ceolus MCC as per USP Chapter < 1062> with an aim to address the concerns of MCC substitution at different stage of formulation development.

Learning Objectives:

  • Current status of nitrosamine challenge and importance of choosing the low nitrite MCC grade to mitigate nitrosamine risk
  • Historical levels of nitrite impurity in Ceolus MCC
  • Tabletability, compressibility and compactibility analysis of Ceolus MCC according to USP