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Volumn 44, Issue 3, 2010, Pages 301-310

Pharmaceutical impurities: An overview

Author keywords

Degradation; Efficacy; Formulation; Impurities

Indexed keywords

1,2 DICHLOROETHYLENE; ACETONITRILE; ADRENALIN; AMLODIPINE BESYLATE; BACLOFEN; CHLOROBENZENE; CHLOROFORM; COLECALCIFEROL; CYCLOHEXANE; DICHLOROMETHANE; DICLOFENAC; DIHYDROERGOTAMINE MESILATE; ERGOMETRINE; HYDROCHLOROTHIAZIDE; KANAMYCIN; KETOROLAC; NALIDIXIC ACID; NIFEDIPINE; NITROPRUSSIDE SODIUM; OFLOXACIN; PARACETAMOL; PENICILLIN G; PENICILLIN G POTASSIUM; PHENOTHIAZINE; QUINOLINE DERIVED ANTIINFECTIVE AGENT; RIBOFLAVIN; TETRACYCLINE; THIOMERSAL; TRYPTOPHAN; UNINDEXED DRUG;

EID: 77957369099     PISSN: 00195464     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (20)

References (33)
  • 2
    • 0000296605 scopus 로고    scopus 로고
    • Draft revised Guidance on Impurities in new drug Substances. Q3A®
    • International Conferences on Harmonization
    • International Conferences on Harmonization, Draft revised Guidance on Impurities in new drug Substances. Q3A®. Federal Register. 2000; 65(140):45085-45090.
    • (2000) Federal Register , vol.65 , Issue.140 , pp. 45085-45090
  • 3
    • 0000296605 scopus 로고    scopus 로고
    • Draft revised Guidance on Impurities in new drug Products. Q3B®
    • International Conferences on Harmonization
    • International Conferences on Harmonization, Draft revised Guidance on Impurities in new drug Products. Q3B®. Federal Register. 2000; 65(139):44791-44797.
    • (2000) Federal Register , vol.65 , Issue.139 , pp. 44791-44797
  • 4
    • 33750838300 scopus 로고    scopus 로고
    • Impurities-Guidelines for residual solvents. Q3C
    • International Conferences on Harmonization
    • International Conferences on Harmonization, Impurities-Guidelines for residual solvents. Q3C. Federal Register. 1997; 62(247): 673-77.
    • (1997) Federal Register , vol.62 , Issue.247 , pp. 673-677
  • 5
    • 77957360405 scopus 로고
    • ICH Topic Q3A; Impurities testing Guideline: Impurities in New drug substances, The European Agency for the Evaluation of Medicinal products Human medicines evaluation unit
    • ICH Topic Q3A; Impurities testing Guideline: Impurities in New drug substances, The European Agency for the Evaluation of Medicinal products Human medicines evaluation unit. 1995.
    • (1995)
  • 6
    • 77957372228 scopus 로고    scopus 로고
    • Q6A: Test procedures and Acceptance Criteria for New drug substances and New drug products
    • International Conferences on Harmonization Specifications
    • International Conferences on Harmonization Specifications. Q6A: Test procedures and Acceptance Criteria for New drug substances and New drug products. Chemical substances. 1999; 65(146): 67488.
    • (1999) Chemical Substances , vol.65 , Issue.146 , pp. 67488
  • 7
    • 0007890743 scopus 로고    scopus 로고
    • Isolation and identification of process related impurities and degradation products from pharmaceutical drug candidates. Part 1. Amer. Pharm
    • Alsante KM, Hatajik TD, Lohr LL, and Sharp TR. Isolation and identification of process related impurities and degradation products from pharmaceutical drug candidates. Part 1. Amer. Pharm. Review. 2001; 4(1): 70-78.
    • (2001) Review , vol.4 , Issue.1 , pp. 70-78
    • Alsante, K.M.1    Hatajik, T.D.2    Lohr, L.L.3    Sharp, T.R.4
  • 9
    • 1542787788 scopus 로고    scopus 로고
    • Sandor, Chemical and analyt ical characterization of related organic impurities in drugs
    • Gorog. Sandor, Chemical and analyt ical characterization of related organic impurities in drugs. Anal. Bioanal.Chem, 2003; 377: 852 - 862.
    • (2003) Anal. Bioanal.Chem , vol.377 , pp. 852-862
    • Gorog1
  • 10
    • 49149094686 scopus 로고    scopus 로고
    • Impurity profile: Significance in Active Pharmaceutical Ingredient
    • Sanjay B. Bari, Bharati R. Kadam, Yogini S. Jaiswal, et al. Impurity profile: Significance in Active Pharmaceutical Ingredient. Eurasian J. Anal. Chem, 2007; 2(1): 32-53.
    • (2007) Eurasian J. Anal. Chem , vol.2 , Issue.1 , pp. 32-53
    • Sanjay, B.B.1    Bharati, R.K.2    Yogini, S.J.3
  • 11
    • 23144461485 scopus 로고    scopus 로고
    • Pharmaceutical Impurities - A mini Review
    • Jiben roy, Pharmaceutical Impurities - A mini Review. AAPS Pharm. sci tech, 2002; 3(2): 1-9.
    • (2002) AAPS Pharm. Sci Tech , vol.3 , Issue.2 , pp. 1-9
    • Roy, J.1
  • 12
    • 0034345521 scopus 로고    scopus 로고
    • Sources of impurities - investigation of 4 - (2 - chlorophenyl) - (3 - ethoxy carbonyl - 5 - methoxy carbonyl - 6 - methyl - 2 -[(2 - phthalimidoethoxy)methyl] - 1,4 - dihydropyridine traces formation during the synthesis of amlodipine besylate
    • Janko Zmitek et.al. Sources of impurities - investigation of 4 - (2 - chlorophenyl) - (3 - ethoxy carbonyl - 5 - methoxy carbonyl - 6 - methyl - 2 -[(2 - phthalimidoethoxy)methyl] - 1,4 - dihydropyridine traces formation during the synthesis of amlodipine besylate. Acta. Chim. Slov.2000; 47: 63 - 68.
    • (2000) Acta. Chim. Slov , vol.47 , pp. 63-68
    • Zmitek, J.1
  • 13
    • 77957359036 scopus 로고    scopus 로고
    • Handbook of Modern Pharmaceutical analysis
    • Ahuja Satinder., Handbook of Modern Pharmaceutical analysis. Academic press, 2001; 298.
    • (2001) Academic Press , pp. 298
    • Satinder, A.1
  • 14
    • 77957354269 scopus 로고    scopus 로고
    • The organic impurities in pharmaceuticals
    • Poonam Kushwaha. The organic impurities in pharmaceuticals. Pharma info. net., 2008, vol.6(4).
    • (2008) Pharma Info. Net , vol.6 , Issue.4
    • Kushwaha, P.1
  • 17
    • 7744246973 scopus 로고    scopus 로고
    • Matrix media selection for the determination of residual solvents in pharmaceutical by static head space chromatography
    • Koji U. Atsuya H, kazuichi U, Masayuki G. Matrix media selection for the determination of residual solvents in pharmaceutical by static head space chromatography, J. Chrom. A. 2004; 1057: 203 - 210.
    • (2004) J. Chrom. A , vol.1057 , pp. 203-210
    • Koji, U.1    Atsuya, H.2    Kazuichi, U.3    Masayuki, G.4
  • 18
    • 77957339160 scopus 로고    scopus 로고
    • Residual solvent analysis in pharmaceuticals
    • April-june
    • Anil M. Dwivedi. Residual solvent analysis in pharmaceuticals. Int. J. Pharma. Excip, 2003; April - june: 33 - 37.
    • (2003) Int. J. Pharma. Excip , pp. 33-37
    • Anil, M.D.1
  • 19
    • 77957369279 scopus 로고    scopus 로고
    • Food and drug administration for immediate release consumer media: 888- Info- FDA. May 6
    • Food and drug administration for immediate release consumer media: 888- Info- FDA. May 6, 1998.
    • (1998)
  • 20
    • 0035038307 scopus 로고    scopus 로고
    • Diclofenac sodium injection sterilized by autoclave and the occurrence of cyclic reaction producing a small amount of impurity
    • Roy J, Islam M, Khan AH, Das SC, Akhteruzzaman M, Deb AK, Alam AH M. Diclofenac sodium injection sterilized by autoclave and the occurrence of cyclic reaction producing a small amount of impurity. J. Pharm. Sci. 2001; (90): 541- 544.
    • (2001) J. Pharm. Sci , vol.90 , pp. 541-544
    • Roy, J.1    Islam, M.2    Khan, A.H.3    Das, S.C.4    Akhteruzzaman, M.5    Deb, A.K.6    Alam, A.H.M.7
  • 22
    • 0030819225 scopus 로고    scopus 로고
    • Injectable ergometrine: Stability and packaging for developing countries
    • Roy J, Bhuiyan K. et al., Injectable ergometrine: Stability and packaging for developing countries. Indian Drugs. 1997; 34(11):634-636.
    • (1997) Indian Drugs , vol.34 , Issue.11 , pp. 634-636
    • Roy, J.1    Bhuiyan, K.2
  • 23
    • 0028075431 scopus 로고
    • Marketed vitamin B-complex injectables: Stability and mutual interaction. Drug Dev
    • Roy J, Mahmud M, Sobhan A, et al., Marketed vitamin B-complex injectables: stability and mutual interaction. Drug Dev. And Ind Pharm. 1994; 20(13): 2157- 2163.
    • (1994) And Ind Pharm , vol.20 , Issue.13 , pp. 2157-2163
    • Roy, J.1    Mahmud, M.2    Sobhan, A.3
  • 29
    • 4344659257 scopus 로고    scopus 로고
    • Pharmaceutical impurity identification: A case study using a Multi disciplinary Approach. Jour. Pharm
    • Alsante K M, Boutres P, Harwood JW et al., Pharmaceutical impurity identification: A case study using a Multi disciplinary Approach. Jour. Pharm. Sci. 2004; 93 (9): 2296.
    • (2296) Sci , vol.93 , Issue.9 , pp. 2004
    • Alsante, K.M.1    Boutres, P.2    Harwood, J.W.3
  • 31
    • 0001957715 scopus 로고    scopus 로고
    • Characterization of pharmaceutical compounds and related substances by using HPLC FTICR-MS and tandem mass spectrometry
    • Winger BE, Kemp CAJ. Characterization of pharmaceutical compounds and related substances by using HPLC FTICR-MS and tandem mass spectrometry. Americ. Pharm. Rev. Summer issue 2001.
    • (2001) Americ. Pharm. Rev. Summer Issue
    • Winger, B.E.1    Kemp, C.A.J.2
  • 32
    • 0030857915 scopus 로고    scopus 로고
    • Profiling degradent of paclitaxel using liquid chromatography-mass spectrometry and liquid chromatography- tandem mass spectrometry sub structural techniques
    • Volk K J, Hill S E. Kerns E H, Lee M S. profiling degradent of paclitaxel using liquid chromatography-mass spectrometry and liquid chromatography- tandem mass spectrometry sub structural techniques. J Chromatogr B. 1997; 696(1): 99.
    • (1997) J Chromatogr B , vol.696 , Issue.1 , pp. 99
    • Volk, K.J.1    Hill, S.E.2    Kerns, E.H.3    Lee, M.S.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.