N-Nitroso Apixaban Amino Acid Impurity

Evaluation of Crushed Tablet for Oral Administration and the Effect of Food on Apixaban Pharmacokinetics in Healthy Adults
YanSongPhD1MingChangPhD1AkiyukiSuzukiMS2Robert J.A.FrostMD, PhD3AnneKellyPhD4FrankLaCretaPhD3CharlesFrostPharmD
Clinical Therapeutics Volume 38, Issue 7, July 2016, Pages 1674-1685.e1
 
Development and validation of seven phenyl hydrazine chloro ester isomers (pgis) by rp-hplc-uv method in anticoagulant drug substance; apixaban
Saradhi venkata ramana v.a,b*, durga raja k.a,b, raghu babu k.a, padma m.a, jagadeesh kumar v.b, pavan kumar k. s. r.b, hemant kumar sharma
Int J Curr Pharm Res, Vol 12, Issue 2, 119-123
 
Stability-Indicating High-Perform ance Liquid Chrom atographie Determ ination of Apixaban in the Presence of Degradation Products
Swarup Suresh Prabhune *, Rajendra Shankar Jaguste, Prakash Laxman Kondalkar, Nitin Sharadchandra Pradhan
Sei Pharm. 2014; 82: 777-785
 
Analytical Quality by Design Approach for a Stability‑Indicating Method to Determine Apixaban and Its Related Impurities
Jéssica B. Ellwanger1  · Nathalie Ribeiro Wingert1  · Nadia Maria Volpato1  · Cássia Virginia Garcia1  · Elfrides E. S. Schapoval1  · Martin Steppe
Chromatographia volume 83, pages65–75(2020)

N-Nitroso Apixaban Amino Acid Impurity is chemically 5-((4-(3-Carbamoyl-1-(4-methoxyphenyl)-7-oxo-1,4,5,7-tetrahydro-6H-pyrazolo[3,4-c]pyridin-6-yl)phenyl)(nitroso)amino)pentanoic acid. N-Nitroso Apixaban Amino Acid Impurity is supplied with detailed characterization data compliant with regulatory guideline. N-Nitroso Apixaban Amino Acid Impurity 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 Apixaban.

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.