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Volumn 10, Issue 2, 2005, Pages 227-232

Degradation of a lyophilized formulation of BMS-204352: Identification of degradants and role of elastomeric closures

Author keywords

Desfluorohydoxy analog; Elastomeric closures; Formaldehyde; Formaldehyde adduct; Hydroxymethyl degradant

Indexed keywords

3 (5 CHLORO 2 METHOXYPHENYL) 3 FLUORO 2,3 DIHYDRO 6 TRIFLUOROMETHYL 1H INDOL 2 ONE; BMS 188929; BMS 215842; ELASTOMER; FORMALDEHYDE; HYDROXYL GROUP; UNCLASSIFIED DRUG;

EID: 18744377490     PISSN: 10837450     EISSN: None     Source Type: Journal    
DOI: 10.1081/PDT-200054429     Document Type: Article
Times cited : (11)

References (12)
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    • Williams, G.R.1    Jiang, J.G.2    Matchar, D.B.3    Samsa, G.P.4
  • 4
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    • Influence of formaldehyde impurity in polysorbate 80 and PEG-300 on the stability of a parenteral formulation of BMS-204352: Identification and control of the degradation product
    • Nassar, M.N.; Nesarikar, V.N.; Lozano, R.; Parker, W.L.; Huang, Y.; Palaniswamy, V.; Xu, W.; Khaselev, N. Influence of formaldehyde impurity in polysorbate 80 and PEG-300 on the stability of a parenteral formulation of BMS-204352: identification and control of the degradation product. Pharm. Dev. Tech. 2004, 9 (2), 189-195.
    • (2004) Pharm. Dev. Tech. , vol.9 , Issue.2 , pp. 189-195
    • Nassar, M.N.1    Nesarikar, V.N.2    Lozano, R.3    Parker, W.L.4    Huang, Y.5    Palaniswamy, V.6    Xu, W.7    Khaselev, N.8
  • 5
    • 18744377799 scopus 로고
    • Elastomeric closures for parenterals
    • Avis, K.E., Lieberman, H.A., Lachman, L., Eds.; Marcel Dekker Inc.: New York
    • Smith, E.J.; Nash, R.J. Elastomeric closures for parenterals. In Pharmaceutical Dosage Forms: Parenteral Medications; Avis, K.E., Lieberman, H.A., Lachman, L., Eds.; Marcel Dekker Inc.: New York, 1992; Vol. 1, 445.
    • (1992) Pharmaceutical Dosage Forms: Parenteral Medications , vol.1 , pp. 445
    • Smith, E.J.1    Nash, R.J.2
  • 6
    • 2642590476 scopus 로고
    • Extractables from elastomeric closures: Analytical procedures for functional group characterization/ identification
    • Parenteral Drug Association: Philadelphia
    • Extractables from elastomeric closures: analytical procedures for functional group characterization/ identification. In Technical Methods Bulletin No. 1; Parenteral Drug Association: Philadelphia, 1980.
    • (1980) Technical Methods Bulletin No. 1
  • 7
    • 0021239335 scopus 로고
    • Quantitative determination of chemicals leached from rubber stoppers into parenteral solutions
    • Danelson, J.W.; Oxborrow, G.S.; Placencia, A.M. Quantitative determination of chemicals leached from rubber stoppers into parenteral solutions. J Parent. Sci. Tech. 1988, 42, 90-93.
    • (1988) J Parent. Sci. Tech. , vol.42 , pp. 90-93
    • Danelson, J.W.1    Oxborrow, G.S.2    Placencia, A.M.3
  • 8
    • 0004023498 scopus 로고
    • Sterile pharmaceutical packaging: Compatibility and stability
    • Patrenteral Drug Association
    • Wang, Y.J.; Chien, Y.W. Sterile pharmaceutical packaging: compatibility and stability. In Technical Bulletin No. 5; Patrenteral Drug Association, 1984.
    • (1984) Technical Bulletin No. 5
    • Wang, Y.J.1    Chien, Y.W.2
  • 10
    • 0021239335 scopus 로고
    • Quantitative determination of chemicals leached from rubber stoppers into parenteral solutions
    • Danielson, J.W.; Oxborrow, G.S.; Placencia, A.M. Quantitative determination of chemicals leached from rubber stoppers into parenteral solutions. J. Parenter. Sci. Technol. 1983, 38, 90-93.
    • (1983) J. Parenter. Sci. Technol. , vol.38 , pp. 90-93
    • Danielson, J.W.1    Oxborrow, G.S.2    Placencia, A.M.3
  • 12
    • 0020446479 scopus 로고
    • Aluminum catalysis of epinephrine degradation in lidocaine hydrochloride with epinephrine solutions
    • Milano, E.A.; Waraszkiewicz, S.W.; DiRubio, R. Aluminum catalysis of epinephrine degradation in lidocaine hydrochloride with epinephrine solutions. J. Parenter. Sci. Technol. 1982, 36, 232-236.
    • (1982) J. Parenter. Sci. Technol. , vol.36 , pp. 232-236
    • Milano, E.A.1    Waraszkiewicz, S.W.2    DiRubio, R.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.