Capecitabine EP Impurity A

Design of experiments (DoE) - based enhanced quality by design approach to hydrolytic degradation kinetic study of capecitabine by eco-​friendly stability indicating UV-​visible spectrophotometry
By Prajapati, Pintu; Patel, Radhika; Patel, Dilan; Shah, Shailesh
From American Journal of PharmTech Research (2020), 10(6), 115-133
 
Validated stability indicating HPLC method for estimation of capecitabine
By Lalitha, K. V.; Raveendra Reddy, J.; Devanna, N.
From International Journal of Pharmaceutical Sciences and Research (2020), 11(11), 5651-5658
 
RP-​HPLC method development and validation for the simultaneous estimation of Irinotecan hydrochloride and Capecitabine in Active Pharmaceutical Ingredients (APIs)
By Vijaya Jyothi, M.; Bhargav, E.; Keerthana, B.; Varalakshmi, Devi K.
From International Journal of Research in Pharmaceutical Sciences (Madurai, India) (2018), 9(1), 63-67

 

Capecitabine EP Impurity A is chemically 4-Amino-1-(5-deoxy-β-D-ribofuranosyl)-5-fluoropyrimidin-2(1H)-one (as per EP). It is also known as Capecitabine USP related compound A ; 5′-deoxy-5-fluorocytidine (EP & USP). Capecitabine EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Capecitabine EP Impurity A 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 Capecitabine.

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.