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Volumn 6, Issue 4, 2011, Pages 217-231

A systematic method development strategy for quantitative color measurement in drug substances, starting materials, and synthetic intermediates

Author keywords

Appearance testing; Diffuse reflectance spectroscopy; Method development strategy (MDS); Quality by design (QbD); Quantitative color measurement; Transmittance spectroscopy

Indexed keywords

2,3 DIMETHYL INDAZOL 6 AMINE; INDAZOLE DERIVATIVE; PAZOPANIB; PIROXICAM; UNCLASSIFIED DRUG;

EID: 84856300369     PISSN: 18725120     EISSN: 19398042     Source Type: Journal    
DOI: 10.1007/s12247-011-9115-5     Document Type: Article
Times cited : (12)

References (30)
  • 3
    • 84856256528 scopus 로고    scopus 로고
    • United States Pharmacopoeia, Rockville: United States Pharmacopoeia
    • United States Pharmacopoeia. USP <1061>-color instrumental measurement. Rockville: United States Pharmacopoeia; 2011.
    • (2011) USP <1061>-color Instrumental Measurement
  • 4
    • 84856275541 scopus 로고    scopus 로고
    • United States Pharmacopoeia, Rockville: United States Pharmacopoeia
    • United States Pharmacopoeia. USP <631>-color and achromaticity. Rockville: United States Pharmacopoeia; 2011.
    • (2011) USP <631>-color and Achromaticity
  • 6
    • 84886177342 scopus 로고    scopus 로고
    • UV/Vis reflectance spectroscopy
    • Brittain HG. UV/Vis reflectance spectroscopy. Drugs Pharmaceut Sci. 2005;160:121-49.
    • (2005) Drugs Pharmaceut Sci. , vol.160 , pp. 121-149
    • Brittain, H.G.1
  • 7
    • 0346514994 scopus 로고
    • Ultraviolet/visible diffuse reflectance spectroscopy
    • Brittain HG. Ultraviolet/visible diffuse reflectance spectroscopy. Drugs Pharmaceut Sci. 1995;70:37-58.
    • (1995) Drugs Pharmaceut Sci. , vol.70 , pp. 37-58
    • Brittain, H.G.1
  • 9
    • 0037006592 scopus 로고    scopus 로고
    • A new method to determine discoloration kinetics of uncoated white tablets occurring during stability testing - An application of instrumental color measurement in the development pharmaceutics
    • DOI 10.1016/S0378-5173(01)00947-4, PII S0378517301009474
    • Berberich J, Dee KH, Hayauchi Y, Pörtner C. A new method to determine discoloration kinetics of uncoated white tablets occurring during stability testing-an application of instrumental color measurement in the development pharmaceutics. Int J Pharm. 2002;234:55-66. (Pubitemid 34142611)
    • (2002) International Journal of Pharmaceutics , vol.234 , Issue.1-2 , pp. 55-66
    • Berberich, J.1    Dee, K.-H.2    Hayauchi, Y.3    Portner, C.4
  • 10
    • 3943054978 scopus 로고
    • A spectrophotometric method for the determination of color of glyceride oils
    • Presnell AK. A spectrophotometric method for the determination of color of glyceride oils. J Am Oil Chem Soc. 1949;26:13-5.
    • (1949) J Am Oil Chem Soc. , vol.26 , pp. 13-15
    • Presnell, A.K.1
  • 11
    • 32944461708 scopus 로고    scopus 로고
    • Color measurement of a solid active pharmaceutical ingredient as an aid to identifying key process parameters
    • DOI 10.1016/j.jpba.2005.08.006, PII S0731708505005662
    • Oram PD, Strine J. Color measurement of a solid active pharmaceutical ingredient as an aid to identifying key process parameters. J Pharm Biomed Anal. 2006;40:1021-4. (Pubitemid 43257911)
    • (2006) Journal of Pharmaceutical and Biomedical Analysis , vol.40 , Issue.4 , pp. 1021-1024
    • Oram, P.D.1    Strine, J.2
  • 12
    • 79251534699 scopus 로고    scopus 로고
    • Development of quality-by-design analytical methods
    • Vogt FG, Kord AS. Development of quality-by-design analytical methods. J Pharm Sci. 2011;100:797-812.
    • (2011) J Pharm Sci. , vol.100 , pp. 797-812
    • Vogt, F.G.1    Kord, A.S.2
  • 13
    • 67649983045 scopus 로고    scopus 로고
    • A systematic approach to RP-HPLC method development in a pharmaceutical QbD environment
    • Li Y, Terfloth G, Kord AS. A systematic approach to RP-HPLC method development in a pharmaceutical QbD environment. Am Pharm Rev. 2009;12:87-95.
    • (2009) Am Pharm Rev. , vol.12 , pp. 87-95
    • Li, Y.1    Terfloth, G.2    Kord, A.S.3
  • 14
    • 77649225942 scopus 로고    scopus 로고
    • A systematic method development strategy for water determinations in drug substance using Karl Fischer titrations
    • Zhou L, Socha JM, Vogt FG, Chen S, Kord AS. A systematic method development strategy for water determinations in drug substance using Karl Fischer titrations. Am Pharm Rev. 2010;13:74-84.
    • (2010) Am Pharm Rev. , vol.13 , pp. 74-84
    • Zhou, L.1    Socha, J.M.2    Vogt, F.G.3    Chen, S.4    Kord, A.S.5
  • 15
    • 77950677448 scopus 로고    scopus 로고
    • Implication and opportunity of applying the principles of quality by design to analytical measurements
    • Schweitzer M, Pohl M, Hanna-Brown M, Nethercote P, Borman P, Hansen G, et al. Implication and opportunity of applying the principles of quality by design to analytical measurements. Pharm Tech. 2010;34:52-9.
    • (2010) Pharm Tech. , vol.34 , pp. 52-59
    • Schweitzer, M.1    Pohl, M.2    Hanna-Brown, M.3    Nethercote, P.4    Borman, P.5    Hansen, G.6
  • 16
    • 77950368349 scopus 로고    scopus 로고
    • Analytical control of process impurities in pazopanib hydrochloride by impurity fate mapping
    • Li Y, Liu DQ, Yang S, Sudini R, McGuire MA, Bhanushali DS, et al. Analytical control of process impurities in pazopanib hydrochloride by impurity fate mapping. J Pharm Biomed Anal. 2010;52:493-507.
    • (2010) J Pharm Biomed Anal. , vol.52 , pp. 493-507
    • Li, Y.1    Liu, D.Q.2    Yang, S.3    Sudini, R.4    McGuire, M.A.5    Bhanushali, D.S.6
  • 17
    • 33947466117 scopus 로고
    • Comparison of transmittance and reflection spectra of 2, 4-dinitrophenylhyfrazones of acetone and 4-methyl-2-pentanone
    • Zeitlen H, Niimoto A. Comparison of transmittance and reflection spectra of 2, 4-dinitrophenylhyfrazones of acetone and 4-methyl-2-pentanone. Anal Chem. 1959;31:1167-70.
    • (1959) Anal Chem. , vol.31 , pp. 1167-1170
    • Zeitlen, H.1    Niimoto, A.2
  • 19
    • 13844321205 scopus 로고
    • The factors affecting the reflectance spectra of some dyes adsorbed on alumina
    • Frei RW, Zeitlen H. The factors affecting the reflectance spectra of some dyes adsorbed on alumina. Anal Chimica Acta. 1965;32:32-9.
    • (1965) Anal Chimica Acta , vol.32 , pp. 32-39
    • Frei, R.W.1    Zeitlen, H.2
  • 20
    • 18744374968 scopus 로고    scopus 로고
    • Mechanochromism of piroxicam accompanied by intermolecular proton transfer probed by spectroscopic methods and solid-phase changes
    • DOI 10.1021/ja045823t
    • Sheth AR, Lubach JW, Munson EJ, Muller FX, Grant DJW. Mechanochromism of piroxicam accompanied by intermolecular proton transfer probed by spectroscopic methods and solid-phase changes. J Am Chem Soc. 2005;127:6641-51. (Pubitemid 40667527)
    • (2005) Journal of the American Chemical Society , vol.127 , Issue.18 , pp. 6641-6651
    • Sheth, A.R.1    Lubach, J.W.2    Munson, E.J.3    Muller, F.X.4    Grant, D.J.W.5
  • 22
    • 0029949804 scopus 로고    scopus 로고
    • Influence of radiation treatment on pharmaceuticals - A review: Alkaloids, morphine derivatives, and antibiotics
    • Boess C, Bögl KW. Influence of radiation treatment on pharmaceuticals-alkaloids, morphine derivatives and antibiotics. Drug Dev Ind Pharm. 1996;22:495-529. (Pubitemid 26197850)
    • (1996) Drug Development and Industrial Pharmacy , vol.22 , Issue.6 , pp. 495-529
    • Boess, C.1    Bogl, K.W.2
  • 23
    • 0030871924 scopus 로고    scopus 로고
    • Preparation and characterization of sealed heated mixture of sublimable compound and porous calcium silicate II: Investigation of the interaction between maltol and porous calcium silicate surface
    • DOI 10.1016/S0378-5173(97)00124-5, PII S0378517397001245
    • Hanawa T, Ikoma R, Sugihara M. Preparation and characterization of sealed heated mixture of sublimable compound and porous calcium silicate II: investigation of the interaction between maltol and porous calcium silicate surface. Int J Pharm. 1997;154:1-8. (Pubitemid 27326814)
    • (1997) International Journal of Pharmaceutics , vol.154 , Issue.1 , pp. 1-8
    • Hanawa, T.1    Ikoma, R.2    Sugihara, M.3
  • 24
    • 38349117679 scopus 로고    scopus 로고
    • Application of instrumental evaluation of color for the pre-formulation and formulation of rabeprazole
    • Rhee YS, Park CW, Shin YS, Kam SH, Lee KY, Park ES. Application of instrumental evaluation of color for the pre-formulation and formulation of rabeprazole. Int J Pharm. 2008;350:122-9.
    • (2008) Int J Pharm. , vol.350 , pp. 122-129
    • Rhee, Y.S.1    Park, C.W.2    Shin, Y.S.3    Kam, S.H.4    Lee, K.Y.5    Park, E.S.6
  • 25
    • 0030601862 scopus 로고    scopus 로고
    • Instrumental evaluation of color of solid dosage forms during stability testing
    • DOI 10.1016/S0378-5173(96)04691-1, PII S0378517396046911
    • Stark G, Fawcett JP, Tucker IG, Weatherall IL. Instrumental evaluation of color of solid dosage forms during stability testing. Int J Pharm. 1996;143:93-100. (Pubitemid 26396403)
    • (1996) International Journal of Pharmaceutics , vol.143 , Issue.1 , pp. 93-100
    • Stark, G.1    Fawcett, J.P.2    Tucker, I.G.3    Weatherall, I.L.4
  • 27
    • 84856275546 scopus 로고    scopus 로고
    • Establishing instrumental color difference tolerances for your products
    • Hunter Laboratories, Reston: Hunter Laboratories
    • Hunter Laboratories. Establishing instrumental color difference tolerances for your products. Applications note, Vol 17, No 12. Reston: Hunter Laboratories; 2008.
    • (2008) Applications Note , vol.17 , Issue.12
  • 29
    • 0036883502 scopus 로고    scopus 로고
    • FMEA methodology design, implementation and integration with HACCP system in a food company
    • DOI 10.1016/S0956-7135(02)00029-4, PII S0956713502000294
    • Scipioni A, Saccarola G, Centazzo A, Arena F. FMEA methodology design, implementation and integration with HACCP system in a food company. Food Control. 2002;13:495-501. (Pubitemid 35252335)
    • (2002) Food Control , vol.13 , Issue.8 , pp. 495-501
    • Scipioni, A.1    Saccarola, G.2    Centazzo, A.3    Arena, F.4
  • 30
    • 0031812305 scopus 로고    scopus 로고
    • Using validation data for ISO measurement uncertainty estimation-part 1. Principles of an approach using cause and effect analysis
    • Ellison SLR, Barwick VJ. Using validation data for ISO measurement uncertainty estimation-part 1. Principles of an approach using cause and effect analysis. Analyst. 1998;123:1387-92.
    • (1998) Analyst. , vol.123 , pp. 1387-1392
    • Ellison, S.L.R.1    Barwick, V.J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.