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Volumn 47, Issue 4-5, 2008, Pages 828-833

Identification of tobramycin impurities for quality control process monitoring using high-performance anion-exchange chromatography with integrated pulsed amperometric detection

Author keywords

2 Deoxystreptamine; Aminoglycoside; Antibiotic; Carbamoyl kanamycin B; Carbamoyl tobramycin; Chromatography; Deoxystreptamine kanosaminide; Electrochemical detection; Fermentation; HPAE IPAD; HPAE PAD; HPLC; Kanamycin A; Kanamycin B; Kanosamine; Neamine; Nebramine; Nebramycin; Neomycin A; Purity; Tobramycin

Indexed keywords

2 DEOXYSTREPTAMINE; AMINE; KANAMYCIN A; KANAMYCIN B; KANOSAMINE; NEAMINE; NEBRAMINE; TOBRAMYCIN;

EID: 46549083817     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2008.04.002     Document Type: Article
Times cited : (23)

References (12)
  • 2
    • 46549083534 scopus 로고    scopus 로고
    • Electronic Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs. Current through April 2007. http://www.fda.gov/cder/ob.
    • Electronic Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs. Current through April 2007. http://www.fda.gov/cder/ob.
  • 3
    • 46549089572 scopus 로고    scopus 로고
    • European Pharmacopoeia (EP), fifth edition (Version 5.0), Tobramycin. Section 0645. The Council of Europe, 67075 Strasbourg Cedex, France, 2002.
    • European Pharmacopoeia (EP), fifth edition (Version 5.0), Tobramycin. Section 0645. The Council of Europe, 67075 Strasbourg Cedex, France, 2002.
  • 7
    • 46549085215 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Q7, Current Step 4 Version, dated 10 November 2000. http://www.ICH.org.
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Q7, Current Step 4 Version, dated 10 November 2000. http://www.ICH.org.
  • 8
    • 46549084401 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Impurities In New Drug Substances, Q3A(R2), Current Step 4 Version, dated 25 October 2006. http://www.ICH.org.
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Impurities In New Drug Substances, Q3A(R2), Current Step 4 Version, dated 25 October 2006. http://www.ICH.org.
  • 9
    • 46549084696 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Impurities In New Drug Substances, Q3B(R2), Current Step 4 Version, dated 2 June 2006. http://www.ICH.org.
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Impurities In New Drug Substances, Q3B(R2), Current Step 4 Version, dated 2 June 2006. http://www.ICH.org.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.