Aspects of melatonin manufacturing and requirements for a reliable active component

NeuroSignals

Volumn 8, Issue 1-2, 1999, Pages 143-146

  Laforce, R ^a   Rigozzi, K ^a   Paganetti, M ^a   Mossi, W ^a   Guainazzi, P ^a   Calderari, G ^a  

^a Helsinn Chemicals SA   (Switzerland)

Author keywords

Analytical methods; Bulk drug substance; Impurities; Impurity profile; Melatonin; Purity; Residual solvent; Stability

Indexed keywords

MELATONIN;

ARTICLE; DRUG ANALYSIS; DRUG PURITY; EOSINOPHILIA MYALGIA SYNDROME; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CONTAMINATION; DRUG INDUSTRY; DRUG STABILITY; EOSINOPHILIA-MYALGIA SYNDROME; HUMANS; MELATONIN; SAFETY;

EID: 0033000929     PISSN: 1424862X     EISSN: 14248638     Source Type: Journal    
DOI: 10.1159/000014583     Document Type: Article

References (2)

1. Williamson L, Tomlinson AJ, Pra-sanna KM, Gleich GJ, Naylor S: Structural characterisation of contaminants found in commercial preparations of melatonin: Similarities to case-related compounds from L-tryptophan associated with eosin-ophilia-myalgia syndrome. Chem Res Toxicol 1998;11:234-240.
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical Products for Human Use (ICH): Guideline for Industry: Impurities in New Drug Substances, ICH-Q3A, Federal Register January 4, 1996 (61 FR 371).