Atazanavir EP Impurity J

Determination of Genotoxic impurity in Atazanavir sulphate drug substance by LC-MS
K. Geetha Bhavania , K. Bala Murali Krishnac , N. Srinivasub* , D. Ramachandranc* , N.V.V.S.S. Ramand , B. Hari Babuc*
J Pharm Biomed Anal. 2017 Jan 5;132:156-158
 
Impact of monomeric vs. micellar surfactant and surfactant-polymer interactions on nucleation-induction times of atazanavir from supersaturated solutions
Anura S. Indulkar, Yi Gao, Shweta Raina, Geoff G.Z. Zhang, and Lynne S. Taylor
Cryst. Growth Des. 2020, 20, 1, 62–72
 
Simultaneous Determination of Impurities of Atazanavir and Ritonavir in Tablet Dosage Form by Using Reversed-Phase Ultra Performance Liquid Chromatographic Method
Murali Krishna V. V. N. Mantripragada1,*, Sumathi V. Rao1 , Venugopal V. S. Nutulapati2 , and Bhaskara P.V. Mantena1
Journal of Chromatographic Science, 2017, 1–15
 
Gradient RP-HPLC method for the determination of potential impurities in atazanavir sulfate
Sreenivasa Rao Chitturi a, Yallappa Somappa Somannavar a, Badarinadh Gupta Peruri a, Sreenivas Nallapati a, Hemant Kumar Sharmaa,∗, Shankar Reddy Budidet a, Vijay Kumar Handaa, Hima Bindu Vurimindi
Journal of Pharmaceutical and Biomedical Analysis 55 (2011) 31–47
 
A selective and sensitive method development and validation by lc-ms/ms approach for trace level quantification of potential genotoxic impurity of boc epoxide in atazanavir sulphate drug substance
Nelaturi subbaiah1*, gopireddy venkata subba reddy2
Int J Pharm Pharm Sci, Vol 9, Issue 9, 143-148

Atazanavir EP Impurity J is chemically Tert-butyl 2-[(2S,3S)-3-(tert-butoxyformamido)-2-hydroxy-4-phenylbutyl]-2-[[4-(pyridin-2-yl)phenyl]methyl]hydrazine-1-carboxylate (as per EP) ; Tert-Butyl 2-{(2S,3S)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-4-phenylbutyl}-2-[4-(pyridin-2-yl)benzyl]hydrazinecarboxylate (as per USP). It is also known as Atazanavir di-tert-butyl analog (USP) ; Des-N-(methoxycarbonyl)-L-tert-leucine Bis-Boc Atazanavir. Atazanavir EP Impurity J is supplied with detailed characterization data compliant with regulatory guideline. Atazanavir EP Impurity J 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 Atazanavir.

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.