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Volumn 9, Issue 1, 2006, Pages 46-53

The role of forced degradation studies in stability indicating HPLC method development

Author keywords

Drug substance; Forced degradation; HPLC; Stability indicating; Stress testing

Indexed keywords

ANALYTIC METHOD; ARTICLE; CHEMICAL REACTION; DEGRADATION KINETICS; EXERCISE TEST; GLACIAL MASS BALANCE; HEAT; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMIDITY; HYDROLYSIS; LIGHT; OXIDATION; SPECTRAL SENSITIVITY;

EID: 55549113576     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (10)

References (14)
  • 1
    • 21144448403 scopus 로고    scopus 로고
    • Developing and Validating Stability-Indicating Methods
    • Swartz M. and Krull I., (2005), "Developing and Validating Stability-Indicating Methods". LCGC North America, 23(6), 586-593.
    • (2005) LCGC North America , vol.23 , Issue.6 , pp. 586-593
    • Swartz, M.1    Krull, I.2
  • 3
    • 3042826837 scopus 로고    scopus 로고
    • Forced Degradation of Pharmaceuticals
    • Reynolds D.W., (2004), "Forced Degradation of Pharmaceuticals". Am Pharm Rev, 7(3), 56-61.
    • (2004) Am Pharm Rev , vol.7 , Issue.3 , pp. 56-61
    • Reynolds, D.W.1
  • 5
    • 55549094939 scopus 로고    scopus 로고
    • International Conference on Harmonization, Stability Testing of New Drug Substances and Products, Q1A (R2), November 2003.
    • International Conference on Harmonization, "Stability Testing of New Drug Substances and Products," Q1A (R2), November 2003.
  • 6
    • 55549105216 scopus 로고    scopus 로고
    • International Conference on Harmonization, Stability Testing: Photostability Testing of New Drug Substance and Products, Q1B, November 1996.
    • International Conference on Harmonization, "Stability Testing: Photostability Testing of New Drug Substance and Products," Q1B, November 1996.
  • 7
    • 55549141649 scopus 로고    scopus 로고
    • International Conference on Harmonization, Evaluation of Stability Data, Q1E, February 2003.
    • International Conference on Harmonization, "Evaluation of Stability Data," Q1E, February 2003.
  • 8
    • 55549137848 scopus 로고    scopus 로고
    • International Conference on Harmonization, Impurities in New Drug Substances, Q3A(R), February 2003.
    • International Conference on Harmonization, "Impurities in New Drug Substances," Q3A(R), February 2003.
  • 9
    • 55549123679 scopus 로고    scopus 로고
    • International Conference on Harmonization, Impurities in New Drug Products, Q3B(R), November 2003.
    • International Conference on Harmonization, "Impurities in New Drug Products," Q3B(R), November 2003.
  • 10
    • 55549092892 scopus 로고    scopus 로고
    • International Conference on Harmonization, Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substance and Products: Chemical Substances, December 2000.
    • International Conference on Harmonization, "Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substance and Products: Chemical Substances," December 2000.
  • 12
    • 0041819811 scopus 로고    scopus 로고
    • A Stress Testing Benchmarking Study
    • Alsante K.M., Martin L., and Baertschi S.W., (2003), "A Stress Testing Benchmarking Study". Pharm Technol, 27(2), 60-72.
    • (2003) Pharm Technol , vol.27 , Issue.2 , pp. 60-72
    • Alsante, K.M.1    Martin, L.2    Baertschi, S.W.3
  • 13
    • 28944442249 scopus 로고    scopus 로고
    • Multi-Dimensional Screening and Analysis (MDSA): An Automated Tool for HPLC
    • Karcher B.D., Davies M.L., Venit J.J., and Delaney E.J., (2004), "Multi-Dimensional Screening and Analysis (MDSA): An Automated Tool for HPLC". Am Pharm Rev, 7(6), 62-66.
    • (2004) Am Pharm Rev , vol.7 , Issue.6 , pp. 62-66
    • Karcher, B.D.1    Davies, M.L.2    Venit, J.J.3    Delaney, E.J.4
  • 14
    • 0035093096 scopus 로고    scopus 로고
    • Oxidative Degradation of Pharmaceuticals: Theory, Mechanisms and Inhibition
    • Hovorka S.W. and Schöneich C., (2001), "Oxidative Degradation of Pharmaceuticals: Theory, Mechanisms and Inhibition". J Pharm Sci, 90(3), 253-269.
    • (2001) J Pharm Sci , vol.90 , Issue.3 , pp. 253-269
    • Hovorka, S.W.1    Schöneich, C.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.