Exemestane Impurity 16

Exemestane Impurity 16 is chemically (3S,8R,9S,10R,13S,14S)-3-Hydroxy-10,13-dimethyl-1,2,3,6,7,8,9,10,11,12,13,14,15,16-tetradecahydro-17H-cyclopenta[a]phenanthren-17-one. Exemestane Impurity 16 is supplied with detailed characterization data compliant with regulatory guideline. Exemestane Impurity 16 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 Exemestane.

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.

Development of validated method for the determination of exemestane by using RP-​HPLC
By Siva Sai Kiran, B.; Raja, S.
From International Journal of Research in Pharmaceutical Sciences (Madurai, India) (2018), 9(1), 185-188
 
Use of the hyphenated LC-​MS​/MS technique and NMR​/IR spectroscopy for the identification of exemestane stress degradation products during the drug development
By Stolarczyk, Elzbieta U.; Rosa, Anna; Kubiszewski, Marek; Zagrodzka, Joanna; Cybulski, Marcin; Kaczmarek, Lukasz
From European Journal of Pharmaceutical Sciences (2017), 109(Suppl.), 389-401
 
A validated stability-​indicating liquid chromatographic method for the determination of Exemestane
By Mathrusri Annapurna, M.; Swati, B.; Naga Ramya, D.; Pramadvara, K.; Sri Ram, A.; Aslesha, N.
From Chemical Science Transactions (2014), 3(3), 961-968, 8 pp..
 
 

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