The application of atomic absorption spectrometry for the determination of residual active pharmaceutical ingredients in cleaning validation samples

References

• Fourman GL, Mullen MV. (1993). Determining cleaning validation acceptance limits for pharmaceutical manufacturing operations. Pharm Technol, 17(4):54–60.
   Google Scholar
• LeBlanc DA. (1998). Establishing scientifically justified acceptance criteria for cleaning validation of finishing drug products. Pharm Technol, 22(10):136–48.
   Google Scholar
• Food and Drug Administration (FDA). (1993, July). Guide to inspections validation of cleaning process. Office of Regional Operations, Office of Regulatory Affairs, Rockville, MD.
   Google Scholar
• Segretario J, Cook SC, Umbles CL, Walker JT, Woodeshick RW, Rubino JT, . (1998). Validation of cleaning procedures for highly potent drugs. II. Bisnafide. Pharmaceutical Devel Technol, 3(4):471–6.
   PubMedGoogle Scholar
• Klinkenberg R, Streel B, Ceccato A. (2003). Development and validation of a liquid chromatographic method for the determination of amlodipine residues on manufacturing equipment surfaces. J Pharm Biomed Anal, 32:345–52.
   PubMed Web of Science ®Google Scholar
• Fazio TT, Singh AK, Kedor-Hackmann ERM, Santoro MIRM. (2007). Quantitative determination and sampling of azathioprine residues for cleaning validation in production area. J Pharm Biomed Anal, 43:1495–8.
   PubMed Web of Science ®Google Scholar
• Guazzaroni M, Yiin B, Yu JL. (1998). Application of total organic carbon analysis for cleaning validation in pharmaceutical manufacturing. Am Biotechnol Lab, 16(10):66–7.
   Google Scholar
• Heinig K, Vogt C, Werner G. (1998). Determination of linear alkylbenzenesulfonates in industrial and environmental samples by capillary electrophoresis. Analyst, 123:349–53.
   Web of Science ®Google Scholar
• Heinig K, Vogt C. (1999). Determination of surfactants by capillary electrophoresis. Electrophoresis, 20:3311–28.
   PubMed Web of Science ®Google Scholar
• Zuin VG, Yariwake JH, Bicchi C. (2003). Fast supercritical fluid extraction and high-resolution gas chromatography with electron-capture and flame photometric detection for multiresidue screening of organochlorine and organophosphorus pesticides in Brazil's medicinal plants. J Chromatogr A, 985:159–66.
   PubMed Web of Science ®Google Scholar
• Mirza T, George RC, Bodenmiller JR, Belanich SA. (1998). Capillary gas chromatographic assay of residual methenamine hippurate in equipment cleaning validation swabs. J Pharm Biomed Anal, 16:939–50.
   PubMed Web of Science ®Google Scholar
• Resto W, Hernandez D, Rey R, Colon H, Zayas J. (2007). Cleaning validation 2: Development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent. J Pharm Biomed Anal, 44:265–9.
   PubMed Web of Science ®Google Scholar
• Biwald CE, Gavlick WK. (1997). Use of total organic carbon analysis and fourier-transform infrared spectroscopy to determine residues of cleaning agents on surfaces. J AOAC Int, 80:1078–83.
   Web of Science ®Google Scholar
• Westman L, Karlsson G. (2000). Methods for detecting residues of cleaning agents during cleaning validation. PDA J Pharm Sci & Technol, 54(5):365–72.
   PubMedGoogle Scholar
• Forsyth R. (2008). Test method validation for cleaning validation samples. Eur Pharm Rev, 2:82–8.
   Google Scholar
• Raghavan R, Mulligan JA. (2000). Low-Level (PPB) determination of cisplatin in cleaning validation (rinse water) samples. I. An atomic absorption spectrophotometric method. Drug Dev Ind Pharm, 26(4):423–8.
   PubMed Web of Science ®Google Scholar
• Abarca A, Canfranc E, Sierra I, Marina ML. (2001). A validated flame AAS method for determining magnesium in a multivitamin pharmaceutical preparation. J Pharm Biomed Anal, 25:941–5.
   PubMed Web of Science ®Google Scholar
• Evans WH, Read JI. (1985). Determination of lithium, rubidium and strontium in foodstuffs. Analyst, 110:619–23.
   PubMed Web of Science ®Google Scholar
• Hulanicki A, Godlewska B, Brzoska M. (1995). Determination of total magnesium in biological samples using electrothermal atomic absorption spectrometry. Spectrochim Acta Part B, 50:1717–24.
   Web of Science ®Google Scholar
• Zhao J, Gao P, Wu S, Zhu D. (2009). Superiority of nitric acid for deproteinization in the determination of trace lithium in serum by graphite furnace atomic absorption spectrometry. J Pharm Biomed Anal, 50:1075–9.
   PubMed Web of Science ®Google Scholar
• International Conference on Harmonization (ICH). (1996, November). Validation of analytical procedures, Methodology (ICH-Q2B). International Conference on Harmonization of technical requirements for the registration of pharmaceuticals for human use.
   Google Scholar
• Thomsen V, Schatzlein D, Mercuro D. (2003). Limits of detection in spectroscopy. Spectroscopy, 18(12):112–4.
   Web of Science ®Google Scholar
• Shifflet MJ, Shapiro M. (2002). Development of analytical methods to accurately and precisely determine residual active pharmaceutical ingredients and cleaning agents on pharmaceutical surfaces. Am Pharm Rev, 5(2):35–41.
   Google Scholar
• Thompson KC, Cummings PM. (1984). Some problems observed in the determination of lithium in waste waters by atomic-absorption spectrophotometry. Analyst, 109:511–4.
   Web of Science ®Google Scholar
• Jeffery GH, Bassett J, Mendham J, Denney RC. (1989). Vogel's textbook of quantitative chemical analysis. 5th ed. Essex, England: Longman Scientific & Technical, 793–94.
   Google Scholar
• Lajunen LHJ. (1992). Spectrochemical analysis by atomic absorption and emission. Cambridge, England: Royal Society of Chemistry, 153.
   Google Scholar