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Volumn 62, Issue 3, 2008, Pages 157-176

A systematic approach for screening glass containers and elastomeric closures for use with parenteral solutions

Author keywords

Compatibility; Compendial compliance; Elastomeric closures; Glass containers; Multi stage strategy; Screening study; Stability; Sterile pharmaceutical packaging; Systematic approach; Water for injection

Indexed keywords

ELASTOMER; GLASS; PARENTERAL SOLUTION; SILICON DIOXIDE;

EID: 50949128627     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (9)

References (11)
  • 1
    • 84962248619 scopus 로고    scopus 로고
    • Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, Rockville, MD, May
    • Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. Guideline on Container Closure Systems for Packaging Human Drugs and Biologics; Rockville, MD, May 2002.
    • (2002) Guideline on Container Closure Systems for Packaging Human Drugs and Biologics
  • 3
    • 56849109505 scopus 로고    scopus 로고
    • United States Pharmacopeial Convention: Rockville, MD
    • United States Pharmacopeia 28. United States Pharmacopeial Convention: Rockville, MD, 2005.
    • (2005) United States Pharmacopeia , pp. 28
  • 4
    • 2942579233 scopus 로고    scopus 로고
    • 5th ed, 5.2, European Directorate for the Quality of Medicines, Council of Europe: Strasbourg, France
    • European Pharmacopoeia, 5th ed. (5.2). European Directorate for the Quality of Medicines, Council of Europe: Strasbourg, France, 2004.
    • (2004) European Pharmacopoeia
  • 5
    • 0003952242 scopus 로고    scopus 로고
    • 14th ed. Society of Japanese Pharmacopoeia: Tokyo, Japan
    • Japanese Pharmacopoeia, 14th ed. Society of Japanese Pharmacopoeia: Tokyo, Japan, 2001.
    • (2001) Japanese Pharmacopoeia
  • 6
    • 0004023498 scopus 로고
    • Sterile Pharmaceutical Packaging: Compatibility and Stability
    • Technical Report No. 5; Parenteral Drug Association
    • Wang, Y. J.; Chien, Y. W. Sterile Pharmaceutical Packaging: Compatibility and Stability; Technical Report No. 5; Parenteral Drug Association, 1984.
    • (1984)
    • Wang, Y.J.1    Chien, Y.W.2
  • 7
    • 0021983664 scopus 로고
    • Glass and rubber closure effects on the pH of water. II. A proposed mechanism of interaction
    • Preston, W. A.; Anderson, N. R. Glass and rubber closure effects on the pH of water. II. A proposed mechanism of interaction. J. Parenteral Sci. Technol. 1985, 39 (1), 28.
    • (1985) J. Parenteral Sci. Technol , vol.39 , Issue.1 , pp. 28
    • Preston, W.A.1    Anderson, N.R.2
  • 8
    • 0018938333 scopus 로고
    • Identification of subvisible barium sulfate crystals in parenteral solutions
    • Boddapati, S.; Butler, D.L.; Im, S.; DeLuca, P. P. Identification of subvisible barium sulfate crystals in parenteral solutions. J. Pharm. Sci. 1980, 69, 608.
    • (1980) J. Pharm. Sci , vol.69 , pp. 608
    • Boddapati, S.1    Butler, D.L.2    Im, S.3    DeLuca, P.P.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.