메뉴 건너뛰기




Volumn 72, Issue 1-2, 2010, Pages 1-6

Regulatory aspects in development of stability-indicating methods: A review

Author keywords

Degradation pathways; Regulatory guidelines; Stability indicating assay methods

Indexed keywords

EXCIPIENT;

EID: 77951823733     PISSN: 00095893     EISSN: 16121112     Source Type: Journal    
DOI: 10.1365/s10337-010-1612-z     Document Type: Review
Times cited : (26)

References (38)
  • 2
    • 0037097780 scopus 로고    scopus 로고
    • Development of validated stability-indicating assay methods - Critical review
    • DOI 10.1016/S0731-7085(02)00047-X, PII S073170850200047X
    • M Bakshi S Singh 2002 J Pharm Biomed Anal 28 1011 1040 10.1016/S0731-7085(02)00047-X 1:CAS:528:DC%2BD38XktFyiur0%3D (Pubitemid 34607392)
    • (2002) Journal of Pharmaceutical and Biomedical Analysis , vol.28 , Issue.6 , pp. 1011-1040
    • Bakshi, M.1    Singh, S.2
  • 5
    • 0032562424 scopus 로고    scopus 로고
    • Stability-indicating analysis of isoxazolyl penicillins using dual wavelength high-performance liquid chromatography
    • DOI 10.1016/S0378-4347(97)00654-3, PII S0378434797006543
    • M Grover M Gulati S Singh 1998 J Chromatogr B Biomed Sci Appl 708 153 159 10.1016/S0378-4347(97)00654-3 1:CAS:528:DyaK1cXjtVKmsrY%3D (Pubitemid 28239899)
    • (1998) Journal of Chromatography B: Biomedical Applications , vol.708 , Issue.1-2 , pp. 153-159
    • Grover, M.1    Gulati, M.2    Singh, S.3
  • 6
    • 77953873112 scopus 로고
    • U.S. Food and Drug Administration
    • U.S. Food and Drug Administration (1987) Drug stability guidelines
    • (1987) Drug Stability Guidelines
  • 13
    • 0004256960 scopus 로고    scopus 로고
    • Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms
    • WHO Technical Report Series 863, World Health Organization, Geneva
    • WHO (1996), Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms, in WHO expert committee on specifications for pharmaceutical preparations. Technical Report Series 863, World Health Organization, Geneva
    • (1996) WHO Expert Committee on Specifications for Pharmaceutical Preparations
  • 28
    • 0008661875 scopus 로고    scopus 로고
    • Guidance for industry U.S. Department of Health and Human Services FDA
    • Guidance for industry (2000) Analytical procedures and method validation. U.S. Department of Health and Human Services FDA (www.fda.gov/guidance/index. htm)
    • (2000) Analytical Procedures and Method Validation
  • 31
    • 77953870724 scopus 로고    scopus 로고
    • The United States Pharmacopoeia 25/National Formulary 20 Rockville, Maryland
    • The United States Pharmacopoeia 25/National Formulary 20 (2002) The United States Pharmacopeial Convention, Inc., Rockville, Maryland, pp 2256
    • (2002) The United States Pharmacopeial Convention, Inc. , pp. 2256
  • 33
    • 77953871324 scopus 로고    scopus 로고
    • Stability testing of new drug substances and products
    • ICH IFPMA, Geneva
    • ICH (2000) Stability testing of new drug substances and products. International conference on harmonization. IFPMA, Geneva, pp 2
    • (2000) International Conference on Harmonization , pp. 2
  • 36
    • 0028358835 scopus 로고
    • Prediction of stability in pharmaceutical preparations. XXI: The analysis and kinetics of hydrolysis of a cocaine degradation product, ecgonine methyl ester, plus the pharmacokinetics of cocaine in the dog [2]
    • DOI 10.1002/jps.2600830233
    • ER Garrett K Seyda 1994 J Pharm Sci 83 269 272 10.1002/jps.2600830233 1:CAS:528:DyaK2cXmt1WisA%3D%3D (Pubitemid 24224193)
    • (1994) Journal of Pharmaceutical Sciences , vol.83 , Issue.2 , pp. 269-272
    • Garrett, E.R.1    Eberst, K.2    Maruhn, D.3
  • 38
    • 77953871821 scopus 로고    scopus 로고
    • 1:CAS:528:DC%2BD28XhtFGrtLfN
    • C Wen 2006 Am Pharm Rev 9 137 140 1:CAS:528:DC%2BD28XhtFGrtLfN
    • (2006) Am Pharm Rev , vol.9 , pp. 137-140
    • Wen, C.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.