Anastrozole EP Impurity A

LC and LC–MS/MS study of forced decomposition behavior of anastrozole and establishment of validated stability-indicating analytical method for impurities estimation in low dose anastrozole tablets
Y. Ramachandra Reddy b,∗, Srinivasan R. Nandana,b,∗∗, D. Vijaya Bharathi c, B. Nagarajua, S. Saidu Reddy b, L.K. Ravindranathb, V. Suryanarayan Rao b
Journal of Pharmaceutical and Biomedical Analysis 50 (2009) 397–404

Preparation of anastrozole loaded PEG-PLA nanoparticles: evaluation of apoptotic response of breast cancer cell lines
Yusra A Alyafee,1,2 Manal Alaamery,1 Shahad Bawazeer,1 Mansour S Almutairi,1 Badr Alghamdi,1 Nawaf Alomran,1 Atia Sheereen,1 Maha Daghestani,2 and Salam Massadeh1,3
Int J Nanomedicine. 2018; 13: 199–208.

Isolation and characterization of process related impurities in anastrozole active pharmaceutical ingredient
S. G. Hiriyanna*; K. Basavaiah
J. Braz. Chem. Soc., Vol. 19, No. 3, 397-404, 2008.

Anastrozole EP Impurity A is chemically 2-[3-[(1RS)-1-Cyanoethyl]-5-(1H-1,2,4-triazol-1-ylmethyl)phenyl]-2-methylpropanenitrile (As per EP) ; 2-(3-(1-Cyanoethyl)-5-(1H-1,2,4-triazol-1-ylmethyl)phenyl)-2-methylpropionitrile (as per USP). It is also known as Desmethyl Anastrozole (USP). Anastrozole EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Anastrozole 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 Anastrozole.

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.