N-Nitroso Amlodipine Impurity-1

Identification and characterization of potential impurities of amlodipine maleate
P. Sudhakar a, M. Nirmala a, J. Moses Babu a,∗, K. Vyas a, Ganta Madhusudan Reddy b, B. Vijaya Bhaskar b, P. Pratap Reddy b, K. Mukkanti c
J. Braz. Chem. Soc., Vol. 19, No. 1, 35-41, 2008.
 
Determination of the Absolute Configuration of the Active Amlodipine Enantiomer as (-)-S: A Correction
Siegfried Goldmann,* Jiirgen Stoltefuss, and Liborius Born
J. Med. Chem. 1992,35,3341-3344
 
Development of a Stability-Indicating HPLC Method for Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium in Bulk and Pharmaceutical Dosage Form
Hafez HM*, Elshanawany AA, Abdelaziz LM and Mohram MS
Hafez et al., Pharm Anal Acta 2014, 5:9

N-Nitroso Amlodipine Impurity-1 is chemically 5-Ethyl 7-methyl 6-(2-chlorophenyl)-8-methyl-4-nitroso-3,4,6,7-tetrahydro-2H-benzo[b][1,4]oxazine-5,7-dicarboxylate. N-Nitroso Amlodipine Impurity-1 is supplied with detailed characterization data compliant with regulatory guideline. N-Nitroso Amlodipine Impurity-1 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 Amlodipine.

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.