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Volumn 10, Issue 3, 2007, Pages

Impact of package leachables on the stability of pharmaceutical products

Author keywords

[No Author keywords available]

Indexed keywords

ALDEHYDE; HYDROPEROXIDE; METAL ION; ORGANIC COMPOUND;

EID: 55749102903     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (17)

References (15)
  • 1
    • 33745657935 scopus 로고    scopus 로고
    • Potential Toxicity of Extractables and Leachables in Drug Products
    • Osterberg, R. E. "Potential Toxicity of Extractables and Leachables in Drug Products," Am. Pharm. Rev., 2005, 8(2), 64-67
    • (2005) Am. Pharm. Rev , vol.8 , Issue.2 , pp. 64-67
    • Osterberg, R.E.1
  • 2
    • 42349083393 scopus 로고    scopus 로고
    • Extractables and Leachables Determination: A Systematic Approach to Select and Qualify a Container Closure System for a Pharmaceutical Product
    • Nicholas, K. "Extractables and Leachables Determination: A Systematic Approach to Select and Qualify a Container Closure System for a Pharmaceutical Product," Am. Pharm. Rev., 2006, 9(3), 21-27.
    • (2006) Am. Pharm. Rev , vol.9 , Issue.3 , pp. 21-27
    • Nicholas, K.1
  • 3
    • 33745658955 scopus 로고    scopus 로고
    • Application of modern analytical technologies to the identification of extractables and leachables
    • Norwood, D. L.; Nagao, L.; Lyapustina, S.; Munos, M. "Application of modern analytical technologies to the identification of extractables and leachables," Am. Pharm. Rev., 2005, 8(1), 78-87
    • (2005) Am. Pharm. Rev , vol.8 , Issue.1 , pp. 78-87
    • Norwood, D.L.1    Nagao, L.2    Lyapustina, S.3    Munos, M.4
  • 4
    • 33745677765 scopus 로고    scopus 로고
    • Selection of Analytical Techniques for Pharmaceutical Leachables Studies
    • Wang, Q. "Selection of Analytical Techniques for Pharmaceutical Leachables Studies," Am. Pharm. Rev., 2005, 8(6), 38-44
    • (2005) Am. Pharm. Rev , vol.8 , Issue.6 , pp. 38-44
    • Wang, Q.1
  • 5
    • 55749095968 scopus 로고    scopus 로고
    • CDER Guidance Document: Container Closure Systems for Packaging Human Drugs and Biologics, 1999; (b) 8. Guideline on Plastic Immediate Packaging Material, EMEA, 2005.
    • (a) CDER Guidance Document: Container Closure Systems for Packaging Human Drugs and Biologics, 1999; (b) 8. Guideline on Plastic Immediate Packaging Material, EMEA, 2005.
  • 9
    • 2942718766 scopus 로고    scopus 로고
    • Antioxidant-Accelerated Oxidative Degradation: A Case Study of Transition Metal Ion Catalyzed Oxidation in Formulation
    • Hong, J.; Lee, E.; Carter, J. C.; Masse, J. A.; Oksanen, D. A. "Antioxidant-Accelerated Oxidative Degradation: A Case Study of Transition Metal Ion Catalyzed Oxidation in Formulation," Pharm. Dev. & Tech., 2004, 9(2), 171-179
    • (2004) Pharm. Dev. & Tech , vol.9 , Issue.2 , pp. 171-179
    • Hong, J.1    Lee, E.2    Carter, J.C.3    Masse, J.A.4    Oksanen, D.A.5
  • 10
    • 0037158499 scopus 로고    scopus 로고
    • Investigation of 4,5-epoxymorphinan degradation during analysis by HPLC
    • Quarry, M. A.; Sebastian, D. S.; Diana, F. "Investigation of 4,5-epoxymorphinan degradation during analysis by HPLC," J. Pharm. Biomed. Anal., 2002, 30, 99-104
    • (2002) J. Pharm. Biomed. Anal , vol.30 , pp. 99-104
    • Quarry, M.A.1    Sebastian, D.S.2    Diana, F.3
  • 11
    • 0037472337 scopus 로고    scopus 로고
    • A new stressed test to predict the foreign matter formation of minodronic acid in solution
    • Nakamura, K, Yokohama, S., Katsuma, M., Sawada, T., Sonobe, T., "A new stressed test to predict the foreign matter formation of minodronic acid in solution," Int. J. Pharm. 2003, 251, 99-106
    • (2003) Int. J. Pharm , vol.251 , pp. 99-106
    • Nakamura, K.1    Yokohama, S.2    Katsuma, M.3    Sawada, T.4    Sonobe, T.5
  • 12
    • 0141481041 scopus 로고    scopus 로고
    • Bohere, D.; Nascimento, P. C.; Binotto, R.; Becker, E. Influence of the glass packing on the contamination of pharmaceutical products by Aluminium. Part III: interaction of the container-chemicals during the heating for sterilization, J. Trace Elem. Med. Biol. 2003, 17(2), 107-115
    • Bohere, D.; Nascimento, P. C.; Binotto, R.; Becker, E. Influence of the glass packing on the contamination of pharmaceutical products by Aluminium. Part III: interaction of the container-chemicals during the heating for sterilization," J. Trace Elem. Med. Biol. 2003, 17(2), 107-115
  • 13
    • 0037026412 scopus 로고    scopus 로고
    • Interaction of Oxidation and Irradiated Ultrahigh Molecular-Weight Polyethylene
    • Shen, F. W.; McKellop, H. A. "Interaction of Oxidation and Irradiated Ultrahigh Molecular-Weight Polyethylene," J. Biomed. Mater. Res. 2002, 61(3), 430-9.
    • (2002) J. Biomed. Mater. Res , vol.61 , Issue.3 , pp. 430-439
    • Shen, F.W.1    McKellop, H.A.2
  • 14
    • 0025778781 scopus 로고
    • A Simple Assay for Lipid Hydroperoxides Based on Triphenylphosphine Oxidation and High Performance Liquid Chromatography
    • Nakamura, T.; Maeda, H. "A Simple Assay for Lipid Hydroperoxides Based on Triphenylphosphine Oxidation and High Performance Liquid Chromatography," Lipids, 1991, 26, 765-768
    • (1991) Lipids , vol.26 , pp. 765-768
    • Nakamura, T.1    Maeda, H.2
  • 15
    • 55749107176 scopus 로고    scopus 로고
    • Welle, F. Migration of Radiolysis Products from Radiation-sterilized Plastics, Pharm. Ind. 2005, 67(8), 970-972 16. Nassar, M. N.; Nesarikar, V. V.; Lozano, R.; Yande, H.; Palaniswamy, V. Degradation of a Lyophilized Formulation of BMS- 204352: Identification of Degradants and Role of Elastomeric Closures, Pharm. Dev. & Tech. 2005, 10(2), 227-232
    • Welle, F. "Migration of Radiolysis Products from Radiation-sterilized Plastics," Pharm. Ind. 2005, 67(8), 970-972 16. Nassar, M. N.; Nesarikar, V. V.; Lozano, R.; Yande, H.; Palaniswamy, V. "Degradation of a Lyophilized Formulation of BMS- 204352: Identification of Degradants and Role of Elastomeric Closures," Pharm. Dev. & Tech. 2005, 10(2), 227-232


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.