Budesonide EP Impurity K

A validated stability indicating UHPLC method for the determination of anti-​inflammatory corticosteroid budesonide epimers
By Vaddi, Lakshmi; Purushothaman, Vijayanthimala; Gowda, Nagaraj
From Journal of Pharmaceutical Sciences and Research (2020), 12(6), 848-852
 
Analytical method development and validation of formoterol fumarate and budesonide in pressurized meter dose inhaler form by using RP-​HPLC
By Raghu, P. S.
From European Journal of Biomedical and Pharmaceutical Sciences (2018), 5(6), 1-6
 
Isolation and characterization of photodegradation impurity in budesonide drug product using LC-​MS and NMR spectroscopy
By Bhutnar, Arun; Khapare, Sachin; Desai, Anita; Dsouza, Smitha
From American Journal of Analytical Chemistry (2017), 8(7), 449-461

Budesonide EP Impurity K is chemically 16α,17-[(1RS)-Butylidenebis(oxy)]-11β,21-dihydroxypregna-1,4-diene-3,20-dione-21-acetate (as per EP); 16α,17-[Butylidenebis(oxy)]-11β-hydroxypregna-1,4-diene-3,20-dione-21-yl acetate (as per USP). It is also known as Budesonide 21-Acetate (USP). Budesonide EP Impurity K is supplied with detailed characterization data compliant with regulatory guideline. Budesonide EP Impurity K 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 Budesonide.

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.