Clarithromycin EP Impurity R

Stability indicating HPLC-​ECD method for the analysis of clarithromycin in pharmaceutical dosage forms: method scaling versus re-​validation
By Makoni, Pedzisai A.; Chikukwa, Mellisa T. R.; Khamanga, Sandile M. M.; Walker, Roderick B.
From Scientia Pharmaceutica (2019), 87(4), 31
 
Stability indicating Rp-​Hplc method development and validation for the simultaneous estimation of gemcitabine and clarithromycin in bulk and pharmaceutical dosage form
By Kumar, Y. Anil; Sirisha, Y.; Harini, A. L.; Prathyusha, A.
From World Journal of Pharmaceutical Research (2018), 7(8Spec.Iss.), 1-8

Selecting optimal columns for clarithromycin impurity analysis according to the quantitative relationship of hydrophobic subtraction model
By Zhang Xia; Hu Changqin
From Journal of pharmaceutical and biomedical analysis (2017), 136, 162-169
 

Clarithromycin EP Impurity R is chemically (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-14-Ethyl-7,12,13-trihydroxy-4-(((2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy)-6-(((2S,3R,4S,6R)-3-hydroxy-6-methyl-4-(methylamino)tetrahydro-2H-pyran-2-yl)oxy)-3,5,7,9,11,13-hexamethyloxacyclotetradecane-2,10-dione. It is also known as N-Desmethyl 6-O-Desmethyl Clarithromycin ; N-Desmethyl Erythromycin A. Clarithromycin EP Impurity R is supplied with detailed characterization data compliant with regulatory guideline. Clarithromycin EP Impurity R 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 Clarithromycin.

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.