Abstract

AMORPHUS SUBSTANTIE (ACTIVATED CHARCOAL) AND OTHER IMPURITIES IN API MANUFACTURING PROCESS. PHARMACEUTICAL, TOXICOLOGICAL AND REGULATORY IMPLICATION

Luisetto M.*, Edbey K., Nili B. Ahmadabadi, Riccardo Benzi Cipelli, Farhan Ahmad Khan, Mashori Gulam Rasool and Oleg Yurevich Latyshev

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Abstract

Aim of this work is to investigate into the inorganic impurities in API manifacturing and related the charcoal Used in purification and other stages. Because the production of activated charcoal imply variuos chemico-phisical process and really high temperature it is of interest to verify if the exfoliation of graphitic-graphene can produce impurity. The same to verify the analitical methdos to determinate its presence or absence in API production and the requirement asked by regulatory international agency. This aspects can be relavant for toxicological and safey aspects: not only to be evaluated the amorphous Activated charcoal residual but also to search graphitic cristals or planar structure of graphene exfoliated even if under the theresholds reported in regulatory rules. It is not the main forcus of this article to put in relation the commercial product showed in this work with the profile of toxicicy of the API purified using this system: only to submit to the researcher some material science concepts useful to better understand some phenomena.

Keywords: Amorphus, Carbonaceus, Graphitic, Graphene, Sio2, Inorganic impurities, Thresholds, Material science, Genotoxicity.