Formoterol EP Impurity I (R,S-isomer)

A novel RP-​HPLC Method for the Simultaneous Estimation of Aclidinium Bromide and Formoterol Fumarate in Bulk and Pharmaceutical Dosage Forms with Stability Studies
By Polisetty, Sai Suharshini; Guruva, Reddy M.
From International Journal of Pharmacy and Pharmaceutical Research (2020), 19(3), 530-544
 
Analytical method development and validation of formoterol and glycopyrrolatein pure and dosage forms by using RP-​HPLC
By Mallikarjuna, R.; Reddy, L. Ramachandra; Dhachinamoorthi, D.
From European Journal of Biomedical and Pharmaceutical Sciences (2019), 6(10), 298-307
 
Simultaneous RP-​HPLC method for determination of impurities in formoterol fumarate and aclidinium bromide in pharmaceutical dosage forms
By Gowda, Ravi; Sathe, Padmakar A.
From International Journal of Chemical and Pharmaceutical Analysis (2016), 3(3), 1-6
 

Formoterol EP Impurity I (R,S-isomer) is chemically N-[2-Hydroxy-5-[(1R)-1-hydroxy-2-[[(1S)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide (as per EP);N-(2-hydroxy-5-[(1R)-1-hydroxy-2-{[(1S)-1-(4-methoxyphenyl)propan-2-yl]amino}ethyl]phenyl)formamide (as per USP). It is also known as (R,S)-Formoterol. Formoterol EP Impurity I (R,S-isomer) is supplied with detailed characterization data compliant with regulatory guideline. Formoterol EP Impurity I (R,S-isomer) can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Formoterol.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.