title: Identification, synthesis and characterization of new impurities in tenofovir.
abstract: A detailed impurity study was conducted on tenofovir, (R)-({[1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)phosphonic acid (1), which is the key starting material of manufacturing the active pharmaceutical ingredient (API) tenofovir disoproxil fumarate (2) based on a recently reported procedure. The major impurities generated in the production of tenofovir (1) have been synthesized, characterized and confirmed. The possible formation mechanisms of these impurities were elucidated herein, which would help to understand the process. In addition, this work will also improve the quality control during manufacturing tenofovir and tenofovir disoproxil fumarate (2).
authors.forename: Zhi
authors.initials: Z
authors.lastname: He
authors.forename: Zhi
authors.initials: Z
authors.lastname: He
authors.forename: Changyuan
authors.initials: C
authors.lastname: Wei
authors.forename: Hongjun
authors.initials: H
authors.lastname: Gao
authors.forename: Yuanqiang
authors.initials: Y
authors.lastname: Li
authors.forename: Daqing
authors.initials: D
authors.lastname: Che
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000032:analysis / Q000138:chemical synthesis; D004340:Drug Contamination; D007202:Indicators and Reagents; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D063065:Organophosphonates / Q000032:analysis* / Q000138:chemical synthesis; D009943:Organophosphorus Compounds / Q000032:analysis; D011786:Quality Control; D018894:Reverse Transcriptase Inhibitors / Q000032:analysis* / Q000138:chemical synthesis; D000068698:Tenofovir
chemical_list: D007202:Indicators and Reagents; D063065:Organophosphonates; D009943:Organophosphorus Compounds; D018894:Reverse Transcriptase Inhibitors; C032627:methylphosphonic acid; D000068698:Tenofovir; D000225:Adenine