Raltegravir EP Impurity A

Development and validation of stability indicating RP-​HPLC assay method of raltegravir in tablet dosage forms
By Shirisha, V.; Sairaju, B.; Illendula, Santhosh; Dutt, K. Rajeswar
From World Journal of Pharmacy and Pharmaceutical Sciences (2019), 8(10), 668-692
 
Stability indicating reverse-​phase high performance liquid chromatography method for the determination of raltegravir in bulk and pharmaceutical formulation
By Annapurna, Mukthinuthalapati Mathrusri; Teja, Gunnam Ravi; Hemchand, S.; Babu, R. Ravi Chandra
From International Journal of Green Pharmacy (2018), 12(1Suppl.), S177-S180
 
Development and validation of RP-​HPLC method for determination of raltegravir and its impurities in bulk drug and dosage forms
By Balaji, M.; AppaRao, K. M. Ch.; Ramakrishna, K.; Srinivasarao, V.
From Pharma Science Monitor (2014), 5(3Suppl.1), 187-196, 10 pp.
 

Raltegravir EP Impurity A is chemically 2-(2-aminopropan-2-yl)-N-[(4-fluorophenyl)methyl]-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide (as per EP); 2-(2-Aminopropan-2-yl)-N-(4-fluorobenzyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide (as per USP). It is also known as Raltegravir amine Impurity. Raltegravir EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Raltegravir 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 Raltegravir.

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.