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Dirithromycin EP Impurity A (CAS No. 26116-56-3),
chemically known as (9S)-9-amino-9-deoxoerythromycin,
is a well-characterized pharmaceutical impurity reference standard associated with
Dirithromycin.
It is widely used by pharmaceutical research laboratories, analytical scientists,
contract research organizations (CROs), and quality control laboratories to support
impurity identification, chromatographic method development, analytical method validation,
and stability studies.
This reference standard plays an important role in ensuring accurate impurity profiling
during the development and quality assessment of Dirithromycin-based pharmaceutical products.
It is suitable for use in analytical techniques such as HPLC, LC-MS, UPLC, and other
validated chromatographic methods where reliable impurity characterization is required.
Dirithromycin EP Impurity A has the molecular formula
C37H70N2O12 and a molecular weight of
735 g/mol.
It is also known by the chemical name
(9S)-9-amino-9-deoxoerythromycin and is identified by
CAS No. 26116-56-3.
Researchers and analytical laboratories utilize this impurity reference standard during
pharmaceutical development, quality control testing, method transfer, and regulatory
compliance activities. Its use helps support the characterization and monitoring of
related substances throughout the product lifecycle.
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