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Volumn 10, Issue 1, 2007, Pages 32-39

Understanding the challenges of extractables and leachables for the pharmaceutical industry - Safety and regulatory environment for pharmaceuticals

Author keywords

[No Author keywords available]

Indexed keywords

DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; GAS CHROMATOGRAPHY; GOOD MANUFACTURING PRACTICE; ION PAIR CHROMATOGRAPHY; LEACHING; MASS SPECTROMETRY; PROCESS DESIGN; REVIEW;

EID: 43349105461     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (11)

References (19)
  • 1
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    • Hopkins, J. L.; Cohen, K. A.; Hatch, F. W.; Pitner, T. P.; Stevenson, J. M.; Hess, F. K. Pharmaceuticals: Tracking Down an Unidentified Trace Level Constituent. Anal. Chem. 1987, 59(11), 784A-786A, 788A, 790A.
    • Hopkins, J. L.; Cohen, K. A.; Hatch, F. W.; Pitner, T. P.; Stevenson, J. M.; Hess, F. K. Pharmaceuticals: Tracking Down an Unidentified Trace Level Constituent. Anal. Chem. 1987, 59(11), 784A-786A, 788A, 790A.
  • 2
    • 0019591190 scopus 로고
    • The Application of Gas Chromatography/Mass Spectrometry to the Analysis of Pharmaceutical Packaging Materials
    • Kiang, P. H. The Application of Gas Chromatography/Mass Spectrometry to the Analysis of Pharmaceutical Packaging Materials. J. Parent. Sci. Technol. 1981, 35 (4), 152-161.
    • (1981) J. Parent. Sci. Technol , vol.35 , Issue.4 , pp. 152-161
    • Kiang, P.H.1
  • 4
    • 55549127684 scopus 로고    scopus 로고
    • Container Closure Systems for Packaging Human Drugs and Biologics; Guidance for Industry; U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CEDER) and Center for Biologics Evaluation and Research (CBER); Rockville, MD, May 1999; 1-41.
    • Container Closure Systems for Packaging Human Drugs and Biologics; Guidance for Industry; U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CEDER) and Center for Biologics Evaluation and Research (CBER); Rockville, MD, May 1999; 1-41.
  • 5
    • 55549111984 scopus 로고    scopus 로고
    • Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products; Draft Guidance for Industry; U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CEDER); Rockville, MD, October 1998; 1-62.
    • Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products; Draft Guidance for Industry; U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CEDER); Rockville, MD, October 1998; 1-62.
  • 6
    • 55549099011 scopus 로고    scopus 로고
    • Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products - Chemistry, Manufacturing, and Controls Documentation; Guidance for Industry; U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CEDER); Rockville, MD, July 2002; 1-45.
    • Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products - Chemistry, Manufacturing, and Controls Documentation; Guidance for Industry; U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CEDER); Rockville, MD, July 2002; 1-45.
  • 7
    • 33745658955 scopus 로고    scopus 로고
    • Application of Modern Analytical Technologies to the Identification of Extractables and Leachables
    • Norwood, D. L.; Nagao, L.; Lyapustina, S.; Munos, M. Application of Modern Analytical Technologies to the Identification of Extractables and Leachables. Am. Pharm. Rev.. 2005, 8 (1), 78-87.
    • (2005) Am. Pharm. Rev , vol.8 , Issue.1 , pp. 78-87
    • Norwood, D.L.1    Nagao, L.2    Lyapustina, S.3    Munos, M.4
  • 8
    • 55549121333 scopus 로고    scopus 로고
    • Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products, PQRI Leachables and Extractables Working Group, available at, accessed November 2006
    • Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products, PQRI Leachables and Extractables Working Group, available at http://www.pqri.org/pdfs/LE_Recommendations_to_FDA_09-29- 06.pdf (accessed November 2006).
  • 9
    • 55549133711 scopus 로고    scopus 로고
    • Leachables and Extractables Testing: Points to Consider, IPAC-RS March 2001, available at http://www.ipacrs.com/leachables.html (accessed March 2005).
    • Leachables and Extractables Testing: Points to Consider, IPAC-RS March 2001, available at http://www.ipacrs.com/leachables.html (accessed March 2005).
  • 10
    • 55549115129 scopus 로고    scopus 로고
    • Implementation of Quality-by-Design: Question-based Review
    • Philadelphia
    • Yu, L. X. Implementation of Quality-by-Design: Question-based Review. 42nd Annual Meeting Drug Information Association; Philadelphia, 2006.
    • (2006) 42nd Annual Meeting Drug Information Association
    • Yu, L.X.1
  • 11
    • 55549115776 scopus 로고    scopus 로고
    • Nasr, M. M. Risk-Based CMC Review and Quality Assessment: What is Quality by Design (QbD)? 2006 FDA/Industry Conference; School of Pharmacy - Temple University; March 29, 2006.
    • Nasr, M. M. Risk-Based CMC Review and Quality Assessment: What is Quality by Design (QbD)? 2006 FDA/Industry Conference; School of Pharmacy - Temple University; March 29, 2006.
  • 16
    • 55549101372 scopus 로고    scopus 로고
    • Tougas, T. IPAC-RS Model OINDP Initiative. IPAC-RS 2006 Conference Inhalation and Nasal Drugs: The Regulatory Landscape. North Bethesda, MD, November 6-8, 2006.
    • Tougas, T. IPAC-RS Model OINDP Initiative. IPAC-RS 2006 Conference Inhalation and Nasal Drugs: The Regulatory Landscape. North Bethesda, MD, November 6-8, 2006.
  • 17
    • 0028963938 scopus 로고
    • Analysis of Polycyclic Aromatic Hydrocarbons in Metered Dose Inhaler Drug Formulations by Isotope Dilution Gas Chromatography/Mass Spectrometry
    • Norwood, D. L.; Prime, D.; Downey, B. P.; Creasey, J.; Satinder, S. K.; Haywood, P. Analysis of Polycyclic Aromatic Hydrocarbons in Metered Dose Inhaler Drug Formulations by Isotope Dilution Gas Chromatography/Mass Spectrometry. J. Pharm. Biomed. Anal., 1995, 13 (3), 293-304.
    • (1995) J. Pharm. Biomed. Anal , vol.13 , Issue.3 , pp. 293-304
    • Norwood, D.L.1    Prime, D.2    Downey, B.P.3    Creasey, J.4    Satinder, S.K.5    Haywood, P.6
  • 19
    • 55549096863 scopus 로고    scopus 로고
    • Good Manufacturing Practices Guideline for Suppliers of Components for Orally Inhaled and Nasal Drug Products, IPAC-RS 2006, further information available at, accessed November 2006
    • Good Manufacturing Practices Guideline for Suppliers of Components for Orally Inhaled and Nasal Drug Products, IPAC-RS 2006, further information available at http://www.ipacrs.com (accessed November 2006).


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.