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Europe / Middle East / Africa / India: Medical Products > Zephex Medical Propellants > Compliance & Regulatory > Pharmacopoeial Monographs

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The preparation of monographs for HFA 134a is under consideration by both the European Pharmacopoeia (Ph Eur) Commission and the United States Pharmacopoeial (USP) Convention. As the leading supplier of HFA 134a for use in medicinal products, Mexichem Fluor has been asked to contribute to the definition of monographs by both Ph Eur and USP. Information concerning specifications, test methods and the validation of these test methods has been provided to both organisations.

Following the publication in Pharmacopoeial Forum 31(6) (November 2005) of a draft monograph for HFA 134a, Mexichem Fluor has offered further comments for consideration by the USP.

In addition, a member of Mexichem Fluor's experienced 'ZEPHEX® Team' is currently participating in the 'Group of Experts' established by the European Pharmacopoeia Commission for the preparation of the monograph for HFA 134a. Nominated for membership of this Group by the British Pharmacopoeia, this involvement of Mexichem Fluor personnel demonstrates the Company's commitment to the pharmacopoeial process. This work on the monograph preparation commenced in July 2003, and is currently ongoing.

The International Non Proprietary Name for ZEPHEX®134a (Norflurane) will be used in the pharmacopoeial monographs.
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