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Volumn 30, Issue 3, 2011, Pages 479-490

Mass spectrometry for small molecule pharmaceutical product development: A review

Author keywords

degradation products; dosage form; drug substance; impurities; mass spectrometry; product development

Indexed keywords

ACTIVE PHARMACEUTICAL INGREDIENTS; CHEMICAL SYNTHESIS; DEGRADATION PRODUCTS; DEVELOPING PROJECTS; DOSAGE FORM; DRUG SUBSTANCE; FORMULATED PRODUCTS; IMPURITIES IN; MULTI-TIERED; PHARMACEUTICAL PRODUCTS; SMALL MOLECULES;

EID: 79954511536     PISSN: 02777037     EISSN: 10982787     Source Type: Journal    
DOI: 10.1002/mas.20289     Document Type: Review
Times cited : (26)

References (67)
  • 1
    • 1842833762 scopus 로고    scopus 로고
    • Recent advances in use of LC/MS/MS for quantitative high-throughput bioanalytical support of drug discovery
    • Ackermann BL, Berna MJ, Murphy AT,. 2002. Recent advances in use of LC/MS/MS for quantitative high-throughput bioanalytical support of drug discovery. Curr Top Med Chem 2: 53-66.
    • (2002) Curr Top Med Chem , vol.2 , pp. 53-66
    • Ackermann, B.L.1    Berna, M.J.2    Murphy, A.T.3
  • 2
    • 0037144162 scopus 로고    scopus 로고
    • Applicability of mass spectrometry to detect coeluting impurities in high-performance liquid chromatography
    • DOI 10.1016/S0021-9673(02)01004-X, PII S002196730201004X
    • Antonovich RS, Keller PR,. 2002. Applicability of mass spectrometry to detect coeluting impurities in high-performance liquid chromatography. J Chromatogr A 971: 159-171. (Pubitemid 35247677)
    • (2002) Journal of Chromatography A , vol.971 , Issue.1-2 , pp. 159-171
    • Antonovich, R.S.1    Keller, P.R.2
  • 3
    • 0036681688 scopus 로고    scopus 로고
    • Estimation of impurity profiles of drugs and related materials: Part XXI. HPLC/UV/MS study of the impurity profile of ethynodiol diacetate
    • DOI 10.1016/S0731-7085(02)00165-6, PII S0731708502001656
    • Babjak M, Balogh G, Gazdag M, Görög S,. 2002. Estimation of impurity profiles of drugs and related materials: Part XXI. HPLC/UV/MS study of the impurity profile of ethynodiol diacetate. J Pharm Biomed Anal 29: 1153-1157. (Pubitemid 34756670)
    • (2002) Journal of Pharmaceutical and Biomedical Analysis , vol.29 , Issue.6 , pp. 1153-1157
    • Babjak, M.1    Balogh, G.2    Gazdag, M.3    Gorog, S.4
  • 4
    • 0037073080 scopus 로고    scopus 로고
    • Comparison between liquid chromatography-UV detection and liquid chromatography-mass spectrometry for the characterization of impurities and/or degradants present in trimethoprim tablets
    • DOI 10.1016/S0021-9673(02)01035-X, PII S002196730201035X
    • Barbarin N, Henion JD, Wu Y,. 2002. Comparison between liquid chromatography-UV detection and liquid chromatography-mass spectrometry for the characterization of impurities and/or degradation products present in trimethoprim tablets. J Chromatogr A 970: 141-154. (Pubitemid 35286574)
    • (2002) Journal of Chromatography A , vol.970 , Issue.1-2 , pp. 141-154
    • Barbarin, N.1    Henion, J.D.2    Wu, Y.3
  • 5
    • 79954457311 scopus 로고    scopus 로고
    • Impurity and Degradation Product Analysis: High Sensitivity Qualitative & Quantitative Analysis Using a Hybrid Triple-Quadrupole-Linear Ion Trap Mass Spectrometer
    • ASMS, Montreal, Quebec, Canada
    • Biesenthal T, Pace N, Impey G,. 2003. Impurity and Degradation Product Analysis: High Sensitivity Qualitative & Quantitative Analysis Using a Hybrid Triple-Quadrupole-Linear Ion Trap Mass Spectrometer. Proceedings of the 51st ASMS Conference on Mass Spectrometry and Allied Topics. ASMS, Montreal, Quebec, Canada.
    • (2003) Proceedings of the 51st ASMS Conference on Mass Spectrometry and Allied Topics
    • Biesenthal, T.1    Pace, N.2    Impey, G.3
  • 6
    • 0031900683 scopus 로고    scopus 로고
    • Atmospheric pressure ionization LC/MS/MS techniques for drug disposition studies
    • DOI 10.1021/js9701059
    • Brewer E, Henion J,. 1998. Atmospheric pressure ionization LC/MS/MS techniques for drug disposition studies. J Pharm Sci 87: 395-402. (Pubitemid 28175798)
    • (1998) Journal of Pharmaceutical Sciences , vol.87 , Issue.4 , pp. 395-402
    • Brewer, E.1    Henion, J.2
  • 7
    • 0030061633 scopus 로고    scopus 로고
    • Determination of liquid chromatographic peak purity by electrospray ionization mass spectrometry
    • DOI 10.1016/0021-9673(95)00766-0
    • Bryant DK, Kingswood MD, Belenguer A,. 1996. Determination of liquid chromatographic peak purity by electrospray ionization mass spectrometry. J Chromatogr A 721: 41-51. (Pubitemid 26039814)
    • (1996) Journal of Chromatography A , vol.721 , Issue.1 , pp. 41-51
    • Bryant, D.K.1    Kingswood, M.D.2    Belenguer, A.3
  • 9
    • 27544513424 scopus 로고    scopus 로고
    • Desorption electrospray ionization mass spectrometry for high-throughput analysis of pharmaceutical samples in the ambient environment
    • DOI 10.1021/ac050989d
    • Chen H, Talaty NN, Takáts Z, Cooks RG,. 2005. Desorption electrospray ionization mass spectrometry for high-throughput analysis of pharmaceutical samples in the ambient environment. Anal Chem 77: 6915-6927. (Pubitemid 41547286)
    • (2005) Analytical Chemistry , vol.77 , Issue.21 , pp. 6915-6927
    • Chen, H.1    Talaty, N.N.2    Takats, Z.3    Cooks, R.G.4
  • 10
    • 33947249054 scopus 로고    scopus 로고
    • Applications of LC/MS in structure identifications of small molecules and proteins in drug discovery
    • DOI 10.1002/jms.1184
    • Chen G, Pramanik BN, Liu Y-H, Mirza UA,. 2007. Applications of LC/MS in structure identifications of small molecules and proteins in drug discovery. J Mass Spectrom 42: 279-287. (Pubitemid 46426672)
    • (2007) Journal of Mass Spectrometry , vol.42 , Issue.3 , pp. 279-287
    • Chen, G.1    Pramanik, B.N.2    Liu, Y.-H.3    Mirza, U.A.4
  • 11
    • 17644408113 scopus 로고    scopus 로고
    • Versatile new ion source for the analysis of materials in open air under ambient conditions
    • DOI 10.1021/ac050162j
    • Cody RB, Laramée JA, Durst HD,. 2005. Versatile new ion source for the analysis of materials in open air under ambient conditions. Anal Chem 77: 2297-2302. (Pubitemid 40562727)
    • (2005) Analytical Chemistry , vol.77 , Issue.8 , pp. 2297-2302
    • Cody, R.B.1    Laramee, J.A.2    Durst, H.D.3
  • 12
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: New estimates of drug development costs
    • DOI 10.1016/S0167-6296(02)00126-1
    • Dimasi JA, Hansen RW, Grabowski HG,. 2003. The price of innovation: New estimates of drug development costs. J Health Econ 22: 151-185. (Pubitemid 36279392)
    • (2003) Journal of Health Economics , vol.22 , Issue.2 , pp. 151-185
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 13
    • 0030660309 scopus 로고    scopus 로고
    • The use of chromatography combined with a quadrupole time-of-flight analyser for the identification of trace impurities in drug substance
    • DOI 10.1002/(SICI)1097-0231(199711)11:17<1916::AID-RCM96>3.0.CO;2-8
    • Eckers C, Haskins N, Langridge J,. 1997. The use of liquid chromatography combined with a quadrupole time-of-flight analyser for the identification of trace impurities in drug substance. Rapid Commun Mass Spectrom 11: 1916-1922. (Pubitemid 27518680)
    • (1997) Rapid Communications in Mass Spectrometry , vol.11 , Issue.17 , pp. 1916-1922
    • Eckers, C.1    Haskins, N.2    Langridge, J.3
  • 14
    • 0032442442 scopus 로고    scopus 로고
    • The use of hyphenated LC-MS technique for characterisation of impurity profiles during drug development
    • DOI 10.1016/S0731-7085(98)00267-2, PII S0731708598002672
    • Ermer J,. 1998. The use of hyphenated LC-MS technique for characterisation of impurity profiles during drug development. J Pharm Biomed Anal 18: 707-714. (Pubitemid 29057799)
    • (1998) Journal of Pharmaceutical and Biomedical Analysis , vol.18 , Issue.4-5 , pp. 707-714
    • Ermer, J.1
  • 15
    • 0033832634 scopus 로고    scopus 로고
    • Applications of hyphenated LC-MS techniques in pharmaceutical analysis
    • Ermer J, Vogel M,. 2000. Applications of hyphenated LC-MS techniques in pharmaceutical analysis. Biomed Chromatogr 14: 373-383.
    • (2000) Biomed Chromatogr , vol.14 , pp. 373-383
    • Ermer, J.1    Vogel, M.2
  • 16
    • 33745587210 scopus 로고    scopus 로고
    • Characterization of solid counterfeit drug samples by desorption electrospray ionization and direct-analysis-in-real-time coupled to time-of-flight mass spectrometry
    • DOI 10.1002/cmdc.200600041
    • Fernández FM, Cody RB, Green MD, Hampton CY, McGready R, Sengaloundeth S, White NJ, Newton PN,. 2006. Characterization of solid counterfeit drug samples by desorption electrospray ionization and direct-analysis-in-real-time coupled to time-of-flight mass spectrometry. ChemMedChem 1: 702-705. (Pubitemid 44154357)
    • (2006) ChemMedChem , vol.1 , Issue.7 , pp. 702-705
    • Fernandez, F.M.1    Cody, R.B.2    Green, M.D.3    Hampton, C.Y.4    McGready, R.5    Sengaloundeth, S.6    White, N.J.7    Newton, P.N.8
  • 17
    • 2942521265 scopus 로고    scopus 로고
    • Improving the detection of degradants and impurities in pharmaceutical drug products by applying mass spectral and chromatographic searching
    • DOI 10.1016/j.jpba.2004.02.015, PII S0731708504000998
    • Freed AL, Kale U, Ando H, Rossi DT, Kingsmill CA,. 2004. Improving the detection of degradation products and impurities in pharmaceutical drug products by applying mass spectral and chromatographic searching. J Pharm Biomed Anal 35: 727-738. (Pubitemid 38757663)
    • (2004) Journal of Pharmaceutical and Biomedical Analysis , vol.35 , Issue.4 , pp. 727-738
    • Freed, A.L.1    Kale, U.2    Ando, H.3    Rossi, D.T.4    Kingsmill, C.A.5
  • 19
    • 0000293683 scopus 로고
    • The use of electrospray ionization with Fourier transform ion cyclotron resonance mass spectrometry in the analysis of trace impurities in a drug substance
    • Haskins NJ, Eckers C, Organ AJ, Dunk MF, Winger BE,. 1995. The use of electrospray ionization with Fourier transform ion cyclotron resonance mass spectrometry in the analysis of trace impurities in a drug substance. Rapid Commun Mass Spectrom 9: 1027-1030.
    • (1995) Rapid Commun Mass Spectrom , vol.9 , pp. 1027-1030
    • Haskins, N.J.1    Eckers, C.2    Organ, A.J.3    Dunk, M.F.4    Winger, B.E.5
  • 20
    • 42749095200 scopus 로고    scopus 로고
    • Design and construction of a microcoil NMR probe for the routine analysis of 20-μL samples
    • Henry ID, Park GHJ, Kc R, Tobias B, Raftery D,. 2008. Design and construction of a microcoil NMR probe for the routine analysis of 20-μL samples. Concepts Magn Reson 33B: 1-8.
    • (2008) Concepts Magn Reson , vol.33 B , pp. 1-8
    • Henry, I.D.1    Park, G.H.J.2    Kc, R.3    Tobias, B.4    Raftery, D.5
  • 25
    • 0031937876 scopus 로고    scopus 로고
    • Characterization of impurities formed by interaction of duloxetine HCl with enteric polymers hydroxypropyl methylcellulose acetate succinate and hydroxypropyl methylcellulose phthalate
    • DOI 10.1021/js970133r
    • Jansen PJ, Oren PL, Kemp CA, Maple SR, Baertschi SW,. 1998. Characterization of impurities formed by interaction of duloxetine HCl with enteric polymers hydroxypropyl methylcellulose acetate succinate and hydroxypropyl methylcellulose phthalate. J Pharm Sci 87: 81-85. (Pubitemid 28079266)
    • (1998) Journal of Pharmaceutical Sciences , vol.87 , Issue.1 , pp. 81-85
    • Jansen, P.J.1    Oren, P.L.2    Kemp, C.A.3    Maple, S.R.4    Baertschi, S.W.5
  • 28
    • 0037656361 scopus 로고    scopus 로고
    • Breaking down barriers: Can LC-MS revolutionize the quantitation of drug product impurities?
    • Kolodsick KJ, Rossi DT, Kingsmill CA,. 2003. Breaking down barriers: Can LC-MS revolutionize the quantitation of drug product impurities? LCGC North Am 21: 468-479.
    • (2003) LCGC North Am , vol.21 , pp. 468-479
    • Kolodsick, K.J.1    Rossi, D.T.2    Kingsmill, C.A.3
  • 29
    • 0035854356 scopus 로고    scopus 로고
    • Union of capillary high-performance liquid chromatography and microcoil nuclear magnetic resonance spectroscopy applied to the separation and identification of terpenoids
    • DOI 10.1016/S0021-9673(01)00912-8, PII S0021967301009128
    • Lacey ME, Tan ZJ, Webb AG, Sweedler JV,. 2001. Union of capillary high-performance liquid chromatography and micorcoil nuclear magnetic resonance spectroscopy applied to the separation and identification of terpenoids. J Chromatogr A 922: 139-149. (Pubitemid 32703587)
    • (2001) Journal of Chromatography A , vol.922 , Issue.1-2 , pp. 139-149
    • Lacey, M.E.1    Tan, Z.J.2    Webb, A.G.3    Sweedler, J.V.4
  • 31
    • 9444297169 scopus 로고    scopus 로고
    • Desiderio D.M., Nibbering N.M.M., editors. New York: John Wiley and Sons
    • Lee M,. 2002. In:, Desiderio DM, Nibbering NMM, editors. LC/MS applications in drug development. New York: John Wiley and Sons. pp. 65-182.
    • (2002) LC/MS Applications in Drug Development , pp. 65-182
    • Lee, M.1
  • 32
    • 0033128171 scopus 로고    scopus 로고
    • LC/MS applications in drug development
    • Lee MS, Kerns EH,. 1999. LC/MS applications in drug development. Mass Spectrom Rev 18: 187-279. (Pubitemid 129660662)
    • (1999) Mass Spectrometry Reviews , vol.18 , Issue.3-4 , pp. 187-279
    • Lee, M.S.1    Kerns, E.H.2
  • 34
    • 58149513118 scopus 로고    scopus 로고
    • n in conjunction with mechanism-based stress studies in the elucidation of drug impurity structure: Rapid identification of a process impurity in betamethasone 17-valerate drug substance
    • n in conjunction with mechanism-based stress studies in the elucidation of drug impurity structure: Rapid identification of a process impurity in betamethasone 17-valerate drug substance. J Pharm Biomed Anal 48: 1451-1456.
    • (2008) J Pharm Biomed Anal , vol.48 , pp. 1451-1456
    • Li, M.1    Lin, M.2    Rustum, A.3
  • 35
    • 0030732906 scopus 로고    scopus 로고
    • Gas chromatography-mass spectrometry determination of isosorbide 5-mononitrate and related impurities in raw materials and dosage formulations
    • DOI 10.1016/S0731-7085(97)00079-4, PII S0731708597000794
    • Marinković VD, Milojković SS, Nedeljković JM, Čomor JJ, Agbaba D, Živanov-Stakić D,. 1997. Gas chromatography-mass spectrometry determination of isosorbide 5-mononitrate and related impurities in raw materials and dosage formulations. J Pharm Biomed Anal 16: 425-429. (Pubitemid 27514384)
    • (1997) Journal of Pharmaceutical and Biomedical Analysis , vol.16 , Issue.3 , pp. 425-429
    • Marinkovic, V.D.1    Milojkovic, S.S.2    Nedeljkovic, J.M.3    Comor, J.J.4    Agbaba, D.5    Zivanov-Stakic, D.6
  • 36
    • 28544448597 scopus 로고    scopus 로고
    • Analysis of solids, liquids, and biological tissues using solids probe introduction at atmospheric pressure on commercial LC/MS instruments
    • DOI 10.1021/ac051470k
    • McEwen CN, McKay RG, Larsen BS,. 2005. Analysis of solids, liquids, and biological tissues using solids probe introduction at atmospheric pressure on commercial LC/MS instruments. Anal Chem 77: 7826-7831. (Pubitemid 41746252)
    • (2005) Analytical Chemistry , vol.77 , Issue.23 , pp. 7826-7831
    • McEwen, C.N.1    McKay, R.G.2    Larsen, B.S.3
  • 38
    • 0031454433 scopus 로고    scopus 로고
    • Characterisation of impurities in bulk drug batches of fluticasone propionate using directly coupled HPLC-NMR spectroscopy and HPLC-MS
    • DOI 10.1016/S0731-7085(97)00103-9, PII S0731708597001039
    • Mistry N, Ismail IM, Smith MS, Nicholson JK, Lindon JC,. 1997. Characterisation of impurities in bulk drug batches of fluticasone propionate using directly coupled HPLC-NMR spectroscopy and HPLC-MS. J Pharm Biomed Anal 16: 697-705. (Pubitemid 28044201)
    • (1997) Journal of Pharmaceutical and Biomedical Analysis , vol.16 , Issue.4 , pp. 697-705
    • Mistry, N.1    Ismail, I.M.2    Smith, M.S.3    Nicholson, J.K.4    Lindon, J.C.5
  • 40
    • 33846816854 scopus 로고    scopus 로고
    • New coupling of planar chromatography with direct analysis in real time mass spectrometry
    • DOI 10.1016/j.chroma.2006.12.056, PII S0021967306024009
    • Morlock G, Ueda Y,. 2007. New coupling of planar chromatography with direct analysis in real time mass spectrometry. J Chromatogr A 1143: 243-251. (Pubitemid 46209102)
    • (2007) Journal of Chromatography A , vol.1143 , Issue.1-2 , pp. 243-251
    • Morlock, G.1    Ueda, Y.2
  • 43
    • 0031907784 scopus 로고    scopus 로고
    • Active drug substance impurity profiling. Part II. LC/MS/MS fingerprinting
    • DOI 10.1016/S0731-7085(97)00132-5, PII S0731708597001325
    • Nicolas EC, Scholz TH,. 1998. Active drug substance impurity profiling: Part II. LC/MS/MS fingerprinting. J Pharm Biomed Anal 16: 825-836. (Pubitemid 28097410)
    • (1998) Journal of Pharmaceutical and Biomedical Analysis , vol.16 , Issue.5 , pp. 825-836
    • Nicolas, E.C.1    Scholz, T.H.2
  • 44
    • 67249163366 scopus 로고    scopus 로고
    • Combining two-dimensional diffusion-ordered nuclear magnetic resonance spectroscopy, imaging desorption electrospray ionization mass spectrometry, and direct analysis in real-time mass spectrometry for the integral investigation of counterfeit pharmaceuticals
    • Nyadong L, Harris GA, Balayssac S, Galhena AS, Malet-Martino M, Martino R, Parry RM, Wang MD, Fernández FM, Gilard V,. 2009. Combining two-dimensional diffusion-ordered nuclear magnetic resonance spectroscopy, imaging desorption electrospray ionization mass spectrometry, and direct analysis in real-time mass spectrometry for the integral investigation of counterfeit pharmaceuticals. Anal Chem 81: 4803-4812.
    • (2009) Anal Chem , vol.81 , pp. 4803-4812
    • Nyadong, L.1    Harris, G.A.2    Balayssac, S.3    Galhena, A.S.4    Malet-Martino, M.5    Martino, R.6    Parry, R.M.7    Wang, M.D.8    Fernández, F.M.9    Gilard, V.10
  • 45
    • 33847246582 scopus 로고    scopus 로고
    • Authentication and fingerprinting of suspect counterfeit drugs
    • Olsen BA, Kiehl DE,. 2006. Authentication and fingerprinting of suspect counterfeit drugs. Am Pharm Rev 9: 115-118.
    • (2006) Am Pharm Rev , vol.9 , pp. 115-118
    • Olsen, B.A.1    Kiehl, D.E.2
  • 48
    • 61449121943 scopus 로고    scopus 로고
    • Identification of a process impurity during the synthesis of a nevirapine analogue HIV NNRT inhibitor using LC/MS and forced degradation studies
    • Qui F, Pennino S, Busacca CA, Norwood DL,. 2009. Identification of a process impurity during the synthesis of a nevirapine analogue HIV NNRT inhibitor using LC/MS and forced degradation studies. J Pharm Biomed Anal 49: 733-738.
    • (2009) J Pharm Biomed Anal , vol.49 , pp. 733-738
    • Qui, F.1    Pennino, S.2    Busacca, C.A.3    Norwood, D.L.4
  • 49
    • 0037136507 scopus 로고    scopus 로고
    • Application of high-field NMR and cryogenic probe technologies in the structural elucidation of Poecillastrin A, a new antitumor macrolide lactam from the sponge Poecillastra species
    • Rashid MA, Gustafson KR, Crouch RC, Groweiss A, Pannel LK, Van QN, Boyd MR,. 2002. Application of high-field NMR and cryogenic probe technologies in the structural elucidation of Poecillastrin A, a new antitumor macrolide lactam from the sponge Poecillastra species. Org Lett 4: 3293-3296.
    • (2002) Org Lett , vol.4 , pp. 3293-3296
    • Rashid, M.A.1    Gustafson, K.R.2    Crouch, R.C.3    Groweiss, A.4    Pannel, L.K.5    Van, Q.N.6    Boyd, M.R.7
  • 50
    • 0037419727 scopus 로고    scopus 로고
    • Utilizing capillary gas chromatography mass spectrometry to determine 4-benzotrifluoride t-butyl ether as a reaction by-product in fluoxetine synthesized using potassium t-butoxide as base
    • DOI 10.1016/S0731-7085(02)00605-2, PII S0731708502006052
    • Robbins DK, Dodson PN, Buccilli LA, Mitchell D,. 2003. Utilizing capillary gas chromatography mass spectrometry to determine 4-benzotrifluoride t-butyl ether as a reaction by-product in fluoxetine synthesized using potassium t-butoxide as base. J Pharm Biomed Anal 31: 63-74. (Pubitemid 36120620)
    • (2003) Journal of Pharmaceutical and Biomedical Analysis , vol.31 , Issue.1 , pp. 63-74
    • Robbins, D.K.1    Dodson, P.N.2    Buccilli, L.A.3    Mitchell, D.4
  • 52
    • 52549109213 scopus 로고    scopus 로고
    • Improving pharmaceutical product development and manufacturing: Impact on cost of drug development and cost of goods sold of pharmaceuticals
    • Suresh P, Basu PK,. 2008. Improving pharmaceutical product development and manufacturing: Impact on cost of drug development and cost of goods sold of pharmaceuticals. J Pharm Innov 3: 175-187.
    • (2008) J Pharm Innov , vol.3 , pp. 175-187
    • Suresh, P.1    Basu, P.K.2
  • 53
    • 5644249240 scopus 로고    scopus 로고
    • Mass spectrometry sampling under ambient conditions with desorption electrospray ionization
    • DOI 10.1126/science.1104404
    • Takáts Z, Wiseman JM, Bogdan G, Cooks RG,. 2004. Mass spectrometry sampling under ambient conditions with desorption electrospray ionization. Science 306: 471-473. (Pubitemid 39372443)
    • (2004) Science , vol.306 , Issue.5695 , pp. 471-473
    • Takats, Z.1    Wiseman, J.M.2    Gologan, B.3    Cooks, R.G.4
  • 55
    • 18844435402 scopus 로고    scopus 로고
    • A generic approach to the impurity profiling of drugs using standardised and independent capillary zone electrophoresis methods coupled to electrospray ionisation mass spectrometry
    • DOI 10.1002/elps.200410261
    • Vassort A, Barrett DA, Shaw PN, Ferguson PD, Szucs R,. 2005. A generic approach to the impurity profiling of drugs using standardised and independent capillary zone electrophoresis methods coupled to electrospray ionisation mass spectrometry. Electrophoresis 26: 1712-1723. (Pubitemid 40691486)
    • (2005) Electrophoresis , vol.26 , Issue.9 , pp. 1712-1723
    • Vassort, A.1    Barrett, D.A.2    Shaw, P.N.3    Ferguson, P.D.4    Szucs, R.5
  • 56
    • 0030249209 scopus 로고    scopus 로고
    • Profiling impurities and degradants of butorphanol tartrate using liquid chromatography/mass spectrometry and liquid chromatography/tandem mass spectrometry substructural techniques
    • DOI 10.1016/0731-7085(96)01841-9
    • Volk KJ, Klohr SE, Rourick RA, Kerns EH, Lee MS,. 1996. Profiling impurities and degradation products of butorphanol tartrate using liquid chromatography/mass spectrometry and liquid chromatography/tandem mass spectrometry substructural techniques. J Pharm Biomed Anal 14: 1663-1674. (Pubitemid 26306904)
    • (1996) Journal of Pharmaceutical and Biomedical Analysis , vol.14 , Issue.12 , pp. 1663-1674
    • Volk, K.J.1    Klohr, S.E.2    Rourick, R.A.3    Kerns, E.H.4    Lee, M.S.5
  • 57
    • 15744385431 scopus 로고    scopus 로고
    • Identification of unknown impurities in simvastatin substance and tablets by liquid chromatography/tandem mass spectrometry
    • DOI 10.1016/j.jpba.2004.11.047
    • Vuletić M, Cindrić M, Koružnjak JD,. 2005. Identification of unknown impurities in simvastatin substance and tablets by liquid chromatography/tandem mass spectrometry. J Pharm Biomed Anal 37: 715-721. (Pubitemid 40417745)
    • (2005) Journal of Pharmaceutical and Biomedical Analysis , vol.37 , Issue.4 , pp. 715-721
    • Vuletic, M.1    Cindric, M.2    Koruznjak, J.D.3
  • 58
    • 15744378812 scopus 로고    scopus 로고
    • Determination of active ingredient within pharmaceutical preparations using flow injection mass spectrometry
    • DOI 10.1016/j.jpba.2004.11.031
    • Wade N, Miller K,. 2005. Determination of active ingredient within pharmaceutical preparations using flow injection mass spectrometry. J Pharm Biomed Anal 37: 669-678. (Pubitemid 40417739)
    • (2005) Journal of Pharmaceutical and Biomedical Analysis , vol.37 , Issue.4 , pp. 669-678
    • Wade, N.1    Miller, K.2
  • 59
    • 33646249136 scopus 로고    scopus 로고
    • The use of recently described ionisation techniques for the rapid analysis of some common drugs and samples of biological origin
    • Williams JP, Patel VJ, Holland R, Scrivens JH,. 2006. The use of recently described ionisation techniques for the rapid analysis of some common drugs and samples of biological origin. Rapid Commun Mass Spectrom 20: 1447-1456.
    • (2006) Rapid Commun Mass Spectrom , vol.20 , pp. 1447-1456
    • Williams, J.P.1    Patel, V.J.2    Holland, R.3    Scrivens, J.H.4
  • 60
    • 0030260340 scopus 로고    scopus 로고
    • A noise and background reduction method for component detection in liquid chromatography/mass spectrometry
    • Windig W, Phalp JM, Payne AW,. 1996. A noise and background reduction method for component detection in liquid chromatography/mass spectrometry. Anal Chem 68: 3602-3606.
    • (1996) Anal Chem , vol.68 , pp. 3602-3606
    • Windig, W.1    Phalp, J.M.2    Payne, A.W.3
  • 61
    • 0001957715 scopus 로고    scopus 로고
    • Characterization of pharmaceutical compounds and related substances by using HPLC FTICR-MS and tandem mass spectrometry
    • 58, 60 62-63.
    • Winger BE, Kemp CAJ,. 2001. Characterization of pharmaceutical compounds and related substances by using HPLC FTICR-MS and tandem mass spectrometry. Am Pharm Rev 4: 55-56, 58, 60 62-63.
    • (2001) Am Pharm Rev , vol.4 , pp. 55-56
    • Winger, B.E.1    Kemp, C.A.J.2
  • 62
    • 0037254484 scopus 로고    scopus 로고
    • TM drug product using accurate mass electrospray ionisation mass spectrometry, accurate mass tandem mass spectrometry and liquid chromatography/mass spectrometry
    • DOI 10.1002/rcm.893
    • Wolff J-C, Thomson LA, Eckers C,. 2003. Identification of the "wrong" active pharmaceutical ingredient in a counterfeit Halfana™ drug product using accurate mass electrospray ionisation mass spectrometry, accurate mass tandem mass spectrometry and liquid chromatography/mass spectrometry. J Rapid Commun Mass Spectrom 17: 215-221. (Pubitemid 36164169)
    • (2003) Rapid Communications in Mass Spectrometry , vol.17 , Issue.3 , pp. 215-221
    • Wolff, J.-C.1    Thomson, L.A.2    Eckers, C.3
  • 63
    • 0345059114 scopus 로고    scopus 로고
    • Identification of oxidative degradates of the TRIS salt of a 5,6,7,8-tetrahydro-1,8-naphthyridine derivative by LC/MS/MS and NMR spectroscopy - Interactions between the active pharmaceutical ingredient and its counterion
    • DOI 10.1016/S0731-7085(03)00423-0
    • Wu Y, Hwang TL, Algayer K, Xu W, Wang H, Procopio A, DeBusi L, Yang CY, Matuszewska B,. 2003. Identification of oxidative degradates of the TRIS salt of a 5,6,7,8-tetrahydro-1,8-naphthyridine derivative by LC/MS/MS and NMR spectroscopy - Interactions between the active pharmaceutical ingredient and its counterion. J Pharm Biomed Anal 33: 999-1015. (Pubitemid 37501003)
    • (2003) Journal of Pharmaceutical and Biomedical Analysis , vol.33 , Issue.5 , pp. 999-1015
    • Wu, Y.1    Hwang, T.-L.2    Algayer, K.3    Xu, W.4    Wang, H.5    Procopio, A.6    Debusi, L.7    Yang, C.-Y.8    Matuszewska, B.9
  • 64
    • 26044449077 scopus 로고    scopus 로고
    • Automated peak tracking for comprehensive impurity profiling in orthogonal liquid chromatographic separation using mass spectrometric detection
    • DOI 10.1016/j.chroma.2004.08.030, PII S0021967304013597
    • Xue G, Bendick AD, Chen R, Sekulic SS,. 2004. Automated peak tracking for comprehensive impurity profiling in orthogonal liquid chromatographic separation using mass spectrometric detection. J Chromatogr. A 1050: 159-171. (Pubitemid 39286240)
    • (2004) Journal of Chromatography A , vol.1050 , Issue.2 , pp. 159-171
    • Xue, G.1    Bendick, A.D.2    Chen, R.3    Sekulic, S.S.4
  • 65
    • 0032968276 scopus 로고    scopus 로고
    • Identification of losartan degradates in stressed tablets by LC-MS and LC-MS/MS
    • DOI 10.1016/S0731-7085(99)00004-7, PII S0731708599000047
    • Zhao Z, Wang Q, Tsai EW, Qin XZ, Ip D,. 1999. Identification of losartan degradates in stressed tablets by LC-MS and LC-MS/MS. J Pharm Biomed Anal 20: 129-136. (Pubitemid 29206590)
    • (1999) Journal of Pharmaceutical and Biomedical Analysis , vol.20 , Issue.1-2 , pp. 129-136
    • Zhao, Z.1    Wang, Q.2    Tsai, E.W.3    Qin, X.-Z.4    Ip, D.5
  • 67
    • 12344280078 scopus 로고    scopus 로고
    • Separation and characterization of synthetic impurities of triclabendazole by reversed-phase high-performance liquid chromatography/ electrospray ionization mass spectrometry
    • DOI 10.1016/j.jpba.2004.09.049, PII S0731708504004868
    • Zhou H, Tai Y, Sun C, Pan Y,. 2005. Separation and characterization of synthetic impurities of triclabendazole by reversed-phase high-performance liquid chromatography/electrospray ionization mass spectrometry. J Pharm Biomed Anal 37: 97-107. (Pubitemid 40138721)
    • (2005) Journal of Pharmaceutical and Biomedical Analysis , vol.37 , Issue.1 , pp. 97-107
    • Zhou, H.1    Tai, Y.2    Sun, C.3    Pan, Y.4


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