Dexamethasone Impurity 13

Stability and compatibility of methotrexate and dexamethasone in 0.9​% sodium chloride for intrathecal injection
By Xu, Fan; Zeng, Su
From Pakistan Journal of Pharmaceutical Sciences (2020), 33(6), 2477-2481
 
Stability indicating RP-​HPLC method development and validation for dexamethasone
By Kulkarni, Pankaj N.; Jadhav, C. K.; Nipate, A. S.; Dodake-Supekar, Alaknanda M.; Gill, C. H.
From Asian Journal of Chemistry (2020), 32(3), 587-591
 

 

Dexamethasone Impurity 13 is chemically (4aS,6aS,7R,8R,9aS,9bS)-7-hydroxy-7-(2-hydroxyacetyl)-4a,6a,8-trimethyl-5a,6,6a,7,8,9,9a,9b,10,11-decahydrocyclopenta[1,2]phenanthro[4,4a-b]oxiren-2(4aH)-one. Dexamethasone Impurity 13 is supplied with detailed characterization data compliant with regulatory guideline. Dexamethasone Impurity 13 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 Dexamethasone.

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.