Low-level quantitation of formaldehyde in drug substance by HPLC-UV

Chromatographia

Volumn 75, Issue 5-6, 2012, Pages 275-280

  Nageswari, A ^a,b   Krishna Reddy, K V S R ^b   Mukkanti, K ^a  

^a JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY   (India)

^b Aptuit Laurus Private Limited   (India)

Author keywords

Active pharmaceutical ingredient; Chromophore; Derivatization; Genotoxic impurity; HPLC UV

Indexed keywords

2,4 DINITROPHENYLHYDRAZINE; DRUG; FORMALDEHYDE;

ACCURACY; ARTICLE; DERIVATIZATION; DRUG IMPURITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIMIT OF DETECTION; LIMIT OF QUANTITATION; MOLECULAR STABILITY; PRIORITY JOURNAL; PROCESS OPTIMIZATION; QUANTITATIVE ANALYSIS; RADIATION DETECTION; SCALE UP; SENSITIVITY AND SPECIFICITY; ULTRAVIOLET RADIATION; ULTRAVIOLET RADIATION DETECTION;

EID: 84862858234     PISSN: 00095893     EISSN: 16121112     Source Type: Journal    
DOI: 10.1007/s10337-012-2186-8     Document Type: Article

References (11)

1. IARC (2006) Monographs on the evaluation of carcinogenic risks to humans, vol 88. International agency for research on cancer Lyon, pp 39-325
2. Report on carcinogens (2005) US Department of Health And Human Services, Public Health Service, National Toxicology Program, 11th edn.
3. 12th report on carcinogens (2011) US national toxicology pro-gram, 10 June
4. Guideline Q3A(R2): Impurities in new drug substances (2006) International Conference on Harmonization (ICH), October
5. Guidelines on the limits of genotixc impurities (2010) European Medicines Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP), London
6. Genotoxic and carcinogenic impurities in drug substances and products: recommended approaches, US Department of Health and Human Services (2008) Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Silver Spring, December
7. Kroes R, Renwick AG, Cheeseman M, Kleiner J, Mangelsdorf I, Piersma A (2004) The threshold of toxicological concern concept in risk assessment. Food Chem Toxicol 42:65-83
8. Wu P, Chang C, Chou S (2003) Determination of formaldehyde in cosmetics by HPLC method and acetylacetone method. J Food Drug Anal 11(1):8-15 (Pubitemid 36656739)
9. Soman A, Qui Y, Chan Li Q (2008) HPLC-UV Method devel-opment and validation for the determination of low level form-aldehyde in a drug substance. J Chrom sci. 46:461-465 (Pubitemid 352006440)
10. ICH Q2(R1) (1995) Guidelines on validation of analytical pro-cedures June, CPMP/ICH/381/95
11. Validation of Compendial Methods (2007) The United States pharmacopeia, 30th edn., USP30