메뉴 건너뛰기




Volumn 58, Issue 1, 2012, Pages 136-140

A stability indicating simultaneous dual wavelength UV-HPLC method for the determination of potential impurities in fampridine active pharmaceutical ingredient

Author keywords

Fampridine; Impurity; Stress study; Validation

Indexed keywords

2 AMINOPYRIDINE; 3 AMINOPYRIDINE; 4 AMINOPYRIDINE; ISONICOTINAMIDE; NICOTINIC ACID;

EID: 80255138052     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.09.009     Document Type: Article
Times cited : (20)

References (8)
  • 2
    • 0347989568 scopus 로고    scopus 로고
    • Pharmacokinetics and safety of multiple oral doses of sustained-release 4-aminopyridine (Fampridine-SR) in subjects with chronic, incomplete spinal cord injury
    • Hayes K.C., Potter P.J., Hsieh J.T., Katz M.A., Blight A.R., Cohen R. Pharmacokinetics and safety of multiple oral doses of sustained-release 4-aminopyridine (Fampridine-SR) in subjects with chronic, incomplete spinal cord injury. Arch. Phy. Med. Rehabil. 2004, 85:29-34.
    • (2004) Arch. Phy. Med. Rehabil. , vol.85 , pp. 29-34
    • Hayes, K.C.1    Potter, P.J.2    Hsieh, J.T.3    Katz, M.A.4    Blight, A.R.5    Cohen, R.6
  • 3
    • 71549141975 scopus 로고    scopus 로고
    • Pharmacokinetics and tolerability of single escalating doses of fampridine sustained-release tablets in patients with multiple sclerosis: a phase I-II, open-label trial
    • Vollmer T., Henney H.R. Pharmacokinetics and tolerability of single escalating doses of fampridine sustained-release tablets in patients with multiple sclerosis: a phase I-II, open-label trial. Clin. Ther. 2009, 31:2206-2210.
    • (2009) Clin. Ther. , vol.31 , pp. 2206-2210
    • Vollmer, T.1    Henney, H.R.2
  • 4
    • 71549172199 scopus 로고    scopus 로고
    • Steady-state pharmacokinetics a tolerability of orally administered fampridine sustained-release 10-mg tablets in patients with multiple sclerosis: a 2-week, open-label, follow-up study
    • Vollmer T., Blight A.R., Henney H.R. Steady-state pharmacokinetics a tolerability of orally administered fampridine sustained-release 10-mg tablets in patients with multiple sclerosis: a 2-week, open-label, follow-up study. Clin. Ther. 2009, 31:2215-2223.
    • (2009) Clin. Ther. , vol.31 , pp. 2215-2223
    • Vollmer, T.1    Blight, A.R.2    Henney, H.R.3
  • 5
    • 11044239238 scopus 로고    scopus 로고
    • Chemical stability of 4-aminopyridine capsules
    • Donnelly R.F. Chemical stability of 4-aminopyridine capsules. Can. J. Hospital Pharm. 2004, 57:284-287.
    • (2004) Can. J. Hospital Pharm. , vol.57 , pp. 284-287
    • Donnelly, R.F.1
  • 6
    • 80255130299 scopus 로고    scopus 로고
    • ICH Guidelines, Stability testing of new drug substances and drug products: text and methodology Q1 A (R2)
    • ICH Guidelines, Stability testing of new drug substances and drug products: text and methodology Q1 A (R2), February 2003.
    • (2003) , Issue.FEBRUARY
  • 7
    • 80255130767 scopus 로고    scopus 로고
    • ICH Guidelines, Validation of analytical procedures stability testing of new drug substances and drug products: text and methodology Q2 (R1)
    • ICH Guidelines, Validation of analytical procedures stability testing of new drug substances and drug products: text and methodology Q2 (R1), November 2005.
    • (2005) , Issue.NOVEMBER
  • 8
    • 80255131754 scopus 로고    scopus 로고
    • ICH Guidelines, Impurities in new drug substances Q3A (R2)
    • ICH Guidelines, Impurities in new drug substances Q3A (R2), October 2006.
    • (2006) , Issue.OCTOBER


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.