Temozolomide EP Impurity B

Design of experiment based validated stability indicating RP-HPLC method of temozolomide in bulk and pharmaceutical dosage forms
Anam Khan, Syed Sarim Imam, Mohd Aqil, Yasmin Sultana, Asgar Ali, Khalid Khan
Beni-Suef University Journal of Basic and Applied Sciences Volume 5, Issue 4, December 2016, Pages 402-408
 
Identification and Physicochemical Characteristics of Temozolomide Process-Related Impurities
Marta Łaszcz, Marek Kubiszewski, Łukasz Jedynak, Monika Kaczmarska, Łukasz Kaczmarek, Wojciech Łuniewski, Krzysztof Gabarski, Anna Witkowska, Krzysztof Kuziak and Maura Malińska
Molecules 2013, 18, 15344-15356
 
Development and Validation of Simultaneous Detrmination of Anastrozole and Temozolomide in Pharmaceutical Dosage Forms
V.N. Daphal*, G. Holkar, R. Yadav & M. Rokade
International Journal of Theoretical & Applied Sciences, 4(2): 48-55(2012)
 
A Stability Indicating UPLC Method for Determination of Temozolomide and its Related Substances in Bulk and Finished Dosage Forms
ramu ivaturi, t. manikya sastry and s. satyaveni
Asian Journal of Chemistry; Vol. 30, No. 9 (2018), 1971-1977

Temozolomide EP Impurity B is chemically 3,4-Dihydro-3-methyl-4-oxo-imidazo[5,1-d][1,2,3,5]tetrazine-8-carboxylic acid ; 3-methyl-4-oxo-3,4-dihydroimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxylic acid. It is also known as Temozolomide Acid. Temozolomide EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Temozolomide 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 Temozolomide.

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.