Tigecycline EP Impurity A

Estimation of related substances in tigecycline by rp-​hplc Method
By Mohan, Bavireddi; Sharma, R. S. K.; Rao, S. V. Murali Mohan; Gopal, N. V. S. Venu
From Oriental Journal of Chemistry (2017), 33(5), 2608-2615
 
Development and validation of an LC-​MS​/MS method for determination of tigecycline and its epimer in human plasma and its application in a pharmacokinetic study
By Wang, Longyuan; Hu, Xiaoxiao; Zhu, Hong; Zhang, Xiaotian; Wang, Chuan; Han, Zhiwu
From Acta Chromatographica (2016), 28(2), 239-253

Development and validation of a novel HPLC method for quantification of tigecycline in bulk and nanoparticle based suspension
By Geetha, M.; Prakash, Rao B.; Rajendra, C. E.; Chaluvaraju, K. C.; Manjula, B. P.
From Journal of Pharmacy and Chemistry (2015), 9(1), 22-26

Tigecycline EP Impurity A is chemically (4R,4aS,5aR,12aS)-9-[2-(tert-butylamino)acetamido]-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide (as per EP) ; (4R,4aS,5aR,12aS)-9-[2-(tert-Butylamino)acetamido]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide (as per USP). It is also known as Tigecycline Epimer (EP & USP). Tigecycline EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Tigecycline 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 Tigecycline.

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.