Sources of impurities - Investigation of 4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-2-[(2- phthalimidoethoxy)methyl]-1,4-dihydropyridine traces formation during the synthesis of amlodipine besylate

Acta Chimica Slovenica

Volumn 47, Issue 1, 2000, Pages 63-68

  Žmitek, Janko ^a   Grahek, Rok ^a   Žižek, Teofil ^a   Furlan, Borut ^a  

^a Lek dd   (Slovenia)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0034345521     PISSN: 13180207     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. Guidance for Industry - ANDAs: Impurities in Drug Substance, Draft Guidance, U.S.Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, June 1998.
2. ICH Guidance on Impurities - A, International Pharmaceutical Regulatory Monitor, 1997.
3. th Edition, Editor Susan Budavari, Merck&Co., Inc., Rahway, N.J., USA, 1989, p.81.
4. EU Pat. 0244944; E.Davison, J. I. Wells (Pfizer Ltd.); Chem. Abstr. 1988, 109, 61453
5. EU Pat. 599220; B.Furlan, A.Čopar, A.Jeriha (Lek); Chem. Abstr. 1995, 122, 81125
6. EU Pat. 0089167; S. F. Campbell, P. E. Cross, J. K. Stubbs (Pfizer Ltd.); Chem. Abstr. 1984, 100, 6351.
7. Internet: www.ec.gc.ca/library/elias/bibrec/3022049J.html (Environment Canada: Health Canada, Government of Canada 1994).