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QI Likai, DI Bin. Advances in research on pharmaceutical impurities[J]. Journal of China Pharmaceutical University, 2015, 46(3): 257-263. DOI: 10.11665/j.issn.1000-5048.20150301
Citation: QI Likai, DI Bin. Advances in research on pharmaceutical impurities[J]. Journal of China Pharmaceutical University, 2015, 46(3): 257-263. DOI: 10.11665/j.issn.1000-5048.20150301

Advances in research on pharmaceutical impurities

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  • Pharmaceutical impurities affect the quality of drugs, and their research is essential in drug development, production and sale. Recently, there have been tremendous advancements in instrumental techniques that allow rapid development of technologies and analytical methods in the research of pharmaceutical impurities. This review discusses the origins and analytical methods of pharmaceutical impurities including genotoxic impurities, and mainly describes the analytical techniques and strategies to assess the genotoxicity of impurities, providing technical references for the study of pharmaceutical impurities.
  • [1]
    Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia:Part 2(中华人民共和国药典:二部)[S].Beijing:China Medical Science Press,2010:310-312.
    [2]
    European Medicines Agency(EMA).Guideline on the limits of genotoxic impurities[EB/OL].[2015-03-02] .http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002903.pdf.
    [3]
    U.S.Department of Health and Human Services Food and Drug Administration(FDA).Guidance for Industry:Genotoxic and Carcinogenic Impurities in Drug Substances and Products:Recommended Approaches[EB/OL].(2008-12-03)[2015-03-02] .http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079235.pdf.
    [4]
    Van Wijk AM,Niederländer HAG,Siebum AHG,et al.A new derivatization reagent for LC-MS/MS screening of potential genotoxic alkylation compounds[J].J Pharm Biomed Anal,2013,74:133-140.
    [5]
    Wu LM,Liu DQ,Vogt FG,et al.Gas-phase derivatization via the Meerwein reaction for selective and sensitive LC-MS analysis of epoxides in active pharmaceutical ingredients[J].J Pharm Biomed Anal,2011,56(5):1106-1111.
    [6]
    Ueyama E,Tamura K,Mizukawa K,et al.Realistic prediction of solid pharmaceutical oxidation products by using a novel forced oxidation system[J].J Pharm Sci,2014,103(4):1184-1193.
    [7]
    Grushka E,Grinberg N.Advances in chromatography.Vol.50[M].Boca Raton:CRC,2012:139-235.
    [8]
    Yamamoto E,Niijima J,Asakawa N.Selective determination of potential impurities in an active pharmaceutical ingredient using HPLC-SPE-HPLC[J].J Pharm Biomed Anal,2013,84:41-47.
    [9]
    Berta R,Babják M,Gazdag M.A study of some practical aspects of high temperature liquid chromatography in pharmaceutical applications[J].J Pharm Biomed Anal,2011,54(3):458-462.
    [10]
    Gallinella B,Bucciarelli L,Zanitti L,et al.Direct separation of the enantiomers of oxaliplatin on a cellulose-based chiral stationary phase in hydrophilic interaction liquid chromatography mode[J].J Chromatogr A,2014,1339:210-213.
    [11]
    Dong MW,Zhang K.Ultra-high-pressure liquid chromatography(UHPLC)in method development[J].Trends Anal Chem,2014,63:21-30.
    [12]
    Reyes-Reyes ML, Roa-Morales G, Melgar-Fernández R, et al. UHPLC determination of enantiomeric purity of sertraline in the presence of its production impurities[J].Chromatographia,2014,77(19/20):1315-1321.
    [13]
    Fekete S,Kohler I,Rudaz S,et al.Importance of instrumentation for fast liquid chromatography in pharmaceutical analysis[J].J Pharm Biomed Anal,2014,87:105-119.
    [14]
    Marley A,Connolly D.Determination of(R)-timolol in(S)-timolol maleate active pharmaceutical ingredient:Validation of a new supercritical fluid chromatography method with an established normal phase liquid chromatography method[J].J Chromatogr A,2014,1325:213-220.
    [15]
    Brondz I,Ekeberg D,Bell DS,et al.Nature of the main contaminant in the drug primaquine diphosphate:SFC and SFC-MS methods of analysis[J].J Pharm Biomed Anal,2007,43(3):937-944.
    [16]
    Ramisetti,NR,Kuntamukkala R,Lakshetti S,et al.Identification and characterization of stress degradants of lacosamide by LC-MS and ESI-Q-TOF-MS/MS:development and validation of a stability indicating RP-HPLC method[J].J Pharm Biomed Anal,2014,95:256-264.
    [17]
    Rinaldi F,Fan J,Pathirana C,et al.Semi-preparative LC-SPE-cryoflow NMR for impurity identifications:use of mother liquor as a better source of impurities[J].Magn Reson Chem,2013,51(9):517-522.
    [18]
    Zhang Y,Zeng L,Pham C,et al.Preparative two-dimensional liquid chromatography/mass spectrometry for the purification of complex pharmaceutical samples[J].J Chromatogr A,2014,1324:86-95.
    [19]
    Zeng L,Xu R,Zhang Y,et al.Two-dimensional supercritical fluid chromatography/mass spectrometry for the enantiomeric analysis and purification of pharmaceutical samples[J].J Chromatogr A,2014,1218(20):3080-3088.
    [20]
    Li S,Wang W,Tang H,et al.Comparison of counter-current chromatography and preparative high performance liquid chromatography applied to separating minor impurities in drug preparations[J].J Chromatogr A,2014,1344:51-58.
    [21]
    Xie XX,Sun BL,Yang YF.Study on removing(-)-bicuculline from Corydalis Decumbentis Rhizomatotal alkaloids by fast centrifugal partition chromatography[J].Chin Tradit Herbal Drugs(中草药),2014,45(19):2787-2792.
    [22]
    Amarouche N,Boudesocque L,Sayagh C,et al.Purification of a modified cyclosporine A by co-current centrifugal partition chromatography:process development and intensification[J].J Chromatogr A,2013,1311:72-78.
    [23]
    Raman NV,Prasad AV,Reddy KR.Sensitive derivatization methods for the determination of genotoxic impurities in drug substances using hyphenated techniques[J].J Pharm Biomed Anal,2014,89:276-281.
    [24]
    Fu M,Lu Q,Hewitt E,et al.Ultra high performance liquid chromatography coupled with high resolution quantitation mass spectrometry method development and validation for determining genotoxic 2,5-dichlorobenzoyl chloride in MLN9708 drug substance[J].J Pharm Biomed Anal,2014,89:233-239.
    [25]
    Neu V,Bielow C,Gostomski I,et al.Rapid and comprehensive impurity profiling of synthetic thyroxine by ultrahigh-performance liquid chromatography-high-resolution mass spectrometry[J].Anal Chem,2013,85(6):3309-3317.
    [26]
    Kind T, Fiehn O. Seven golden rules for heuristic filtering of molecular formulas obtained by accurate mass spectrometry[J].BMC Bioinf,2007,8(1):105.
    [27]
    Foti C,Alsante K,Cheng G,et al.Tools and workflow for structure elucidation of drug degradation products[J].Trends Anal Chem,2013,49:89-99.
    [28]
    Awasthi A,Razzak M,Al-Kassas R,et al.Separation and identification of degradation products in eprinomectin formulation using LC,LTQ FT-MS,H/D exchange,and NMR[J].J Pharm Biomed Anal,2012,63:62-73.
    [29]
    Smith M,Thickitt C.The benefit of sample pretreatment and use of MS10 on the Orbitrap for the analysis of pentasaccharides[J].Rapid Commun Mass Spectrom,2009,23(18):3018-3022.
    [30]
    Shah RP,Sahu A,Singh S.Identification and characterization of degradation products of irbesartan using LC-MS/TOF,MSn,on-line H/D exchange and LC-NMR[J].J Pharm Biomed Anal,2010,51(5):1037-1046.
    [31]
    Chen GD,Khusid A,Daaro I,et al.Structural identification of trace level enol tautomer impurity by on-line hydrogen/deuterium exchange HR-LC/MS in a LTQ-Orbitrap hybrid mass spectrometer[J].J Mass Spectrom,2007,42(7):967-970.
    [32]
    Shah RP, Garg A, Putlur SP, et al. Practical and economical implementation of online H/D exchange in LC-MS[J].Anal Chem,2013,85(22):10904-10912.
    [33]
    Jiang MH,Yu XB,Mao LS,et al.Quantitative determination of 10-O-(N,N-dimethylaminoethyl)-ginkgolide B methanesulfonate by nuclear magnetic resonance[J].J China Pharm Univ(中国药科大学学报),2013,44(4):339-342.
    [34]
    Foley DA,Wang J,Maranzano B,et al.Online NMR and HPLC as a reaction monitoring platform for pharmaceutical process development[J].Anal Chem,2013,85(19):8928-8932.
    [35]
    Kovacs H,Moskau D,Spraul M.Cryogenically cooled probes—a leap in NMR technology[J].Prog Nucl Magn Reson Spectrosc,2005,46(2):131-155.
    [36]
    Devenport NA,Sealey LC,Alruways FH,et al.Direct detection of a sulfonate ester genotoxic impurity by atmospheric-pressure thermal desorption-extractive electrospray-mass spectrometry[J].Anal Chem,2013,85(13):6224-6227.
    [37]
    Neu V,Bielow C,Reinert K,et al.Ultrahigh-performance liquid chromatography-ultraviolet absorbance detection-high-resolution-mass spectrometry combined with automated data processing for studying the kinetics of oxidative thermal degradation of thyroxine in the solid state[J].J Chromatogr A,2014,1371:196-203.
    [38]
    McGovern T,Jacobson-Kram D.Regulation of genotoxic and carcinogenic impurities in drug substances and products[J].Trends Anal Chem,2006,25(8):790-795.
    [39]
    Raman NVVSS,Prasad AVSS,Reddy KR.Strategies for the identification,control and determination of genotoxic impurities in drug substances:a pharmaceutical industry perspective[J].J Pharm Biomed Anal,2011,55(4):662-667.
    [40]
    Kakasaheb NA,Ramakrishna K,Srinivasarao V.Method development and validation by GC-MS for quantification of 1-chloroethyl cyclohexyl carbonate as a genotoxic impurity in candesartan cilexetil drug substance[J].Int J Pharm Pharm Sci,2014,6(11):370-372.
    [41]
    Cassano A,Raitano G,Mombelli E,et al.Evaluation of QSAR models for the prediction of Ames genotoxicity:a retrospective exercise on the chemical substances registered under the EU REACH regulation[J].J Environ Sci Health Part C,2014,32(3):273-298.
    [42]
    European Medicines Agency(EMA).Questions and answers on the ‘Guideline on the limits of genotoxic impurities’[EB/OL].(2010-09-23)[2015-03-02] .http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002907.pdf.
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