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Volumn 25, Issue 5, 2008, Pages 1100-1109

The USP performance verification test, part I: USP Lot P prednisone tablets - Quality attributes and experimental variables contributing to dissolution variance

Author keywords

Dissolution; Performance verification; Performance verification test; Quality assurance; United States Pharmacopeia

Indexed keywords

PREDNISONE;

EID: 40949103730     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-007-9498-7     Document Type: Article
Times cited : (23)

References (20)
  • 1
    • 42049112377 scopus 로고    scopus 로고
    • USP. United States Pharmacopeial Convention, Inc. Rockville, MD
    • USP, USP 30-NF 25, Dissolution <711>, United States Pharmacopeial Convention, Inc., Rockville, MD, 2001, pp. 277-282.
    • (2001) USP 30-NF 25, Dissolution <711> , pp. 277-282
  • 6
    • 34248590106 scopus 로고    scopus 로고
    • Guidance on federal conformity assessment activities
    • NIST
    • NIST. Guidance on federal conformity assessment activities. Fed. Regist. 65:48894-48902 (2000).
    • (2000) Fed. Regist , vol.65 , pp. 48894-48902
  • 12
    • 84962124777 scopus 로고    scopus 로고
    • Perturbation study of dissolution apparatus variables-a design of experiment approach
    • J. Eaton, G. Deng, W. W. Hauck, W. Brown, R. G. Manning, and S. Wahab. Perturbation study of dissolution apparatus variables-a design of experiment approach. Dissolution Technol. 14:20-26 (2007).
    • (2007) Dissolution Technol. , vol.14 , pp. 20-26
    • Eaton, J.1    Deng, G.2    Hauck, W.W.3    Brown, W.4    Manning, R.G.5    Wahab, S.6
  • 14
    • 0032923660 scopus 로고    scopus 로고
    • Typical variability in drug dissolution testing: Study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product
    • S. A. Qureshi, and I. J. McGilveray. Typical variability in drug dissolution testing: study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product. Eur. J. Pharm. Sci. 7:249-258 (1999).
    • (1999) Eur. J. Pharm. Sci. , vol.7 , pp. 249-258
    • Qureshi, S.A.1    McGilveray, I.J.2
  • 15
    • 0033674245 scopus 로고    scopus 로고
    • Cause of high variability in drug dissolution testing and its impact on setting tolerances
    • S. A. Qureshi, and J. Shabnam. Cause of high variability in drug dissolution testing and its impact on setting tolerances. Eur. J. Pharm. Sci. 12:271-276 (2001).
    • (2001) Eur. J. Pharm. Sci. , vol.12 , pp. 271-276
    • Qureshi, S.A.1    Shabnam, J.2
  • 16
    • 34547153725 scopus 로고    scopus 로고
    • Studies of variability in dissolution testing with USP apparatus 2
    • Z. Gao, T. W. Moore, A. P. Smith, W. H. Doub, and B. J. Westenberger. Studies of variability in dissolution testing with USP apparatus 2. J. Pharm. Sci. 96:1794-1801 (2007).
    • (2007) J. Pharm. Sci. , vol.96 , pp. 1794-1801
    • Gao, Z.1    Moore, T.W.2    Smith, A.P.3    Doub, W.H.4    Westenberger, B.J.5
  • 17
    • 13844276813 scopus 로고    scopus 로고
    • Hydrodynamics-induced variability in the USP Apparatus 2 dissolution test
    • J. L. Baxter, J. Kukura, and F. J. Muzzio. Hydrodynamics-induced variability in the USP Apparatus 2 dissolution test. Int. J. Pharm. 292:17-29 (2005).
    • (2005) Int. J. Pharm. , vol.292 , pp. 17-29
    • Baxter, J.L.1    Kukura, J.2    Muzzio, F.J.3
  • 18
    • 3242754188 scopus 로고    scopus 로고
    • Shear distribution and variability in the USP apparatus 2 under turbulent conditions
    • J. Kukura, J. L. Baxter, and F. J. Muzzio. Shear distribution and variability in the USP apparatus 2 under turbulent conditions. Int. J. Pharm. 279:9-17 (2004).
    • (2004) Int. J. Pharm. , vol.279 , pp. 9-17
    • Kukura, J.1    Baxter, J.L.2    Muzzio, F.J.3
  • 20
    • 84962107062 scopus 로고    scopus 로고
    • Comments on mechanical and chemical calibration by an instrument manufacturer
    • R. Hanson. Comments on mechanical and chemical calibration by an instrument manufacturer. Dissolution Technol. 14:7(2007).
    • (2007) Dissolution Technol. , vol.14 , pp. 7
    • Hanson, R.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.