N-Nitroso Azithromycin EP Impurity A

Determination of azithromycin in raw materials and pharmaceutical formulations by HPLC coupled with an evaporative light scattering detector
Aiguo Zenga, Xia Liua, Siruo Zhangb, Yan Zhengc, Ping Huangc,Kangli Dua, Qiang Fu
Asian Journal of Pharmaceutical Sciences 9(2):107–116
 
LC determination of impurities in azithromycin tablets
L. Miguel, C. Barbas
Journal of Pharmaceutical and Biomedical Analysis 33 (2003) 211/217
 
Agglomeration Mechanism of Azithromycin Dihydrate in Acetone− Water Mixtures and Optimization of the Powder Properties
Songgu Wu,†,‡ Huan Shen,†,‡ Kangli Li,†,‡ Bo Yu,†,‡ Shijie Xu,†,‡ Mingyang Chen,†,‡ Junbo Gong,*,†,‡ and Bao hong Hou
Ind. Eng. Chem. Res. 2016, 55, 17, 4905–4910
 
Characterization of four unknown impurities in azithromycin and erythromycin iminoether by 2D LC/Q-TOF MS and NMR
Yong jina, , Xu Yub , Jinjin Zhoub , Zhikui Zhoua , Jian Wang
Rapid Commun Mass Spectrom. 2020 Jun 15;34(11):e8772.
 
Analysis of Azithromycin and Its Related Compounds by RP-HPLC with UV Detection
Fuad Al-Rimawi1 and Maher Kharoaf
Journal of Chromatographic Science, Vol. 48, February 2010
 
Development and Validation of RP- UHPLC Method for Azithromycin and Its Related Compounds in Tablet Dosage Form
Santosh Kumar Bhardwaj*1,2, Dau Dayal Agarwal1 , Vivek Sharma1 and Subodh Kumar Budakoti
Journal of Chemical and Pharmaceutical Research, 2016, 8(7):113-122

N-Nitroso Azithromycin EP Impurity A is chemically (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-(((2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-2-ethyl-3,4,10-trihydroxy-13-(((2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy)-3,5,8,10,12,14-hexamethyl-6-nitroso-1-oxa-6-azacyclopentadecan-15-one. It is also known as N-Nitroso Azaerythromycin A ; N-Nitroso N-Desmethyl Azithromycin. N-Nitroso Azithromycin EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. N-Nitroso Azithromycin 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 Azithromycin.

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.