BRIEFING
Formoterol Fumarate Inhalation Solution. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure in the Assay was validated using the Kinetex C8 brand of column with L7 packing. The typical retention time for formoterol is about 6 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Zorbax SB C8 brand of column with L7 packing. The typical retention time for formoterol is about 33 min.
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The Limit of Formoterol Related Compound I test is based on the liquid chromatographic procedure validated using the Shodex Asahipak ODP-50-4D brand of column with L67 packing. The typical retention times for formoterol fumarate and formoterol fumarate related compound I are about 11.5 and 13.2 min, respectively.
Performance tests for this inhalation product monograph have not been included at this time to address the stakeholders' concern that the inclusion of detailed performance tests in inhalation drug product monographs adds a regulatory burden that potentially impedes the approval of generic drug products already in development. This is because manufacturers are required to demonstrate their product's conformance (or to address non-conformance) to the performance test requirements in the public standard. It should not be interpreted to imply that performance quality tests are unnecessary for inhalation drug products. These tests remain a critical aspect of the overall quality controls for these complex dosage forms. The importance of performance quality tests is specifically addressed in Inhalation and Nasal Drug Products—General Information and Product Quality Tests 〈5〉. Additionally, standardized apparatus and procedures for the execution of these tests are described in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests 〈601〉. USP is engaged with stakeholders to explore new ways of addressing these important performance quality tests for inhalation drug products within the public standard in a manner that will not impede generic development.
(SM5: S. Shivaprasad)
Case ID—SUB-534