Sildenafil EP Impurity B

Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet
Michael A Veronin , Mohammad T Nutan , Uday Krishna Reddy Dodla
Ther Adv Drug Saf. 2014 Oct;5(5):180-9
 
Validated Methods for Determination of Sildenafil Citrate in The Presence of its Potential Impurities
A.E. El-Gindy , E. Shokry M. Farouk , L. Abd El-Aziz
J Biomed Sci and Res., Vol 2 (4), 2010,262-278
 
Validated LC method for sildenafil citrate related substances and its potential oxidative degradation product
A.Nageswari, P.Surya Prakash Rao, B.Gowri Sankar Rao, B.Satyanarayana , M.Saravanan , V.Ranga Reddy , Mukkanti
ACAIJ, 10(10) 2011 [683-690]
 
Determinaton of sildenafil citrate and related substances in the commercial products and tablet dosage form using HPLC
N Daraghmeh, M Al-Omari, A.ABadwan, A.M.YJaber
Journal of Pharmaceutical and Biomedical Analysis Volume 25, Issues 3–4, June 2001, Pages 483-492

Sildenafil EP Impurity B is chemically 5-[2-Ethoxy-5-[(4-methyl-4-oxido-1-piperazinyl)sulfonyl]phenyl]-1,6-dihydro-1-methyl-3-propyl-7H-pyrazolo[4,3-d]pyrimidin-7-one . It is also known as Sildenafil N-Oxide. Sildenafil EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Sildenafil EP Impurity B 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 Sildenafil .

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.