Quantification of polymorphic impurity in an enantiotropic polymorph system using differential scanning calorimetry, X-ray powder diffraction and Raman spectroscopy

International Journal of Pharmaceutics

Volumn 415, Issue 1-2, 2011, Pages 110-118

  Li, Yi ^a   Chow, Pui Shan ^a   Tan, Reginald B H ^a,b  

^a INSTITUTE OF CHEMICAL AND ENGINEERING SCIENCES   (Singapore)

^b NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

Author keywords

DSC; Polymorphic impurity; PXRD; Quantification; Raman; Sulfamerazine

Indexed keywords

SULFAMERAZINE;

ACCURACY; ARTICLE; CALIBRATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG IMPURITY; DRUG TRANSFORMATION; ENANTIOMER; HEATING; INTERMETHOD COMPARISON; MELTING POINT; PRIORITY JOURNAL; RAMAN SPECTROMETRY; X RAY POWDER DIFFRACTION;

ANTI-BACTERIAL AGENTS; CALIBRATION; CALORIMETRY, DIFFERENTIAL SCANNING; CRYSTALLIZATION; DRUG CONTAMINATION; MULTIVARIATE ANALYSIS; PHARMACEUTICAL PREPARATIONS; POWDER DIFFRACTION; PREDICTIVE VALUE OF TESTS; SPECTRUM ANALYSIS, RAMAN; SULFAMERAZINE; THERMODYNAMICS; X-RAY DIFFRACTION;

EID: 79960179638     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2011.05.058     Document Type: Article

References (34)

1. K.R. Acharya, K.N. Kuchela, and G. Kartha Crystal structure of sulfamerazine J. Cryst. Spectrosc. Res. 12 1982 369 376
2. R.J. Behme, and D. Brooke Heat of fusion measurement of a low melting polymorph of carbamazepine that undergoes multiple-phase changes during differential scanning calorimetry analysis J. Pharm. Sci. 80 1991 986 990
3. H.G. Brittain Methods for the characterization of polymorphs and solvates H.G. Brittain, Polymorphism in Pharmaceutical Solids 1999 Marcel Dekker, Inc. New York
4. X. Cao, C. Sun, and T.J. Thamann A study of sulfamerazine single crystals using atomic force microscopy, transmission light microscopy, and Raman spectroscopy J. Pharm. Sci. 94 2005 1881 1892 (Pubitemid 41551474)
5. M.R. Caria, and R. Mohamed Positive indentification of two orthorhombic polymorphs of sulfamerazine (C11H12N4O2S), their thermal analyses and structural comparison Acta Crystallogr.; Sect. B: Struct. Sci. 48 1992 492 498
6. N. Chieng, S. Rehder, D. Saville, T. Rades, and J. Aaltonen Quantitative solid-state analysis of three solid forms of ranitidine hydrochloride in ternary mixtures using Raman spectroscopy and X-ray powder diffraction J. Pharm. Biomed. Anal. 49 2009 18 25
7. Y. Gong, B.M. Collman, S.M. Mehrens, E. Lu, J.M. Miller, A. Blackburn, and D.J.W. Grant Stable-form screening: overcoming trace impurities that inhibit solution-mediated phase transformation to the stable polymorph of sulfamerazine J. Pharm. Sci. 97 2008 2130 2144
8. C.H. Gu, K. Chatterjee, V. Young Jr.; and D.J.W. Grant Stabilization of a metastable polymorph of sulfamerazine by structurally related additives J. Cryst. Growth 235 2002 471 481 (Pubitemid 34070397)
9. C.H. Gu, V. Young, and D.J.W. Grant Polymorph screening: influence of solvents on the rate of solvent-mediated polymorphic transformation J. Pharm. Sci. 90 2001 1878 1890 (Pubitemid 33062608)
10. A. Heinz, M. Savolainen, T. Rades, and C.J. Strachan Quantifying ternary mixtures of different solid-state forms of indomethacin by Raman and near-infrared spectroscopy Eur. J. Pharm. Sci. 32 2007 182 192 (Pubitemid 47532710)
11. G.M.G. Hossain A new polymorph of sulfamerazine Acta Crystallogr.; Sect. E: Struct. Rep. Online 62 2006 o2166 o2167
12. J. Johansson, S. Pettersson, and L.S. Taylor Infrared imaging of laser-induced heating during Raman spectroscopy of pharmaceutical solids J. Pharm. Biomed. Anal. 30 2002 1223 1231 (Pubitemid 35284334)
13. F.W. Langkilde, J. Sjöblom, L. Tekensberg-Hjelte, and J. Mrak Quantitative FT-Raman analysis of two crystal forms of a pharmaceutical compound J. Pharm. Biomed. Anal. 15 1997 687 696 (Pubitemid 27171123)
14. C. McGregor, and E. Bines The use of high-speed differential scanning calorimetry (Hyper-DSCTM) in the study of pharmaceutical polymorphs Int. J. Pharm. 350 2008 48 52
15. C. McGregor, M.H. Saunders, G. Buckton, and R.D. Saklatvala The use of high-speed differential scanning calorimetry (Hyper-DSCTM) to study the thermal properties of carbamazepine polymorphs Thermochim. Acta 417 2004 231 237
16. Z. Német, A. Demeter, and G. Pokol Quantifying low levels of polymorphic impurity in clopidogrel bisulphate by vibrational spectroscopy and chemometrics J. Pharm. Biomed. Anal. 49 2009 32 41
17. L.E. O'Brien, P. Timmins, A.C. Williams, and P. York Use of in situ FT-Raman spectroscopy to study the kinetics of the transformation of carbamazepine polymorphs J. Pharm. Biomed. Anal. 36 2004 335 340 (Pubitemid 39371078)
18. M. Pellow-Jarman, P.J. Hendra, and R.J. Lehnert The dependence of Raman signal intensity on particle size for crystal powders Vib. Spectrosc. 12 1996 257 261 (Pubitemid 126401389)
19. D. Pratiwi, J.P. Fawcett, K.C. Gordon, and T. Rades Quantitative analysis of polymorphic mixtures of ranitidine hydrochloride by Raman spectroscopy and principal components analysis Eur. J. Pharm. Biopharm. 54 2002 337 341 (Pubitemid 35341835)
20. S.N.C. Roberts, A.C. Williams, I.M. Grimsey, and S.W. Booth Quantitative analysis of mannitol polymorphs. FT-Raman spectroscopy J. Pharm. Biomed. Anal. 28 2002 1135 1147 (Pubitemid 34607399)
21. S.N.C. Roberts, A.C. Williams, I.M. Grimsey, and S.W. Booth Quantitative analysis of mannitol polymorphs. X-ray powder diffractometry-exploring preferred orientation effects J. Pharm. Biomed. Anal. 28 2002 1149 1159 (Pubitemid 34607400)
22. B. Shah, V.K. Kakumanu, and A.K. Bansal Analytical techniques for quantification of amorphous/crystalline phases in pharmaceutical solids J. Pharm. Sci. 95 2006 1641 1665 (Pubitemid 44229572)
23. G. Socrates Infrared and Raman Characteristic Group Frequencies: Tables and Charts 3rd ed. 2001 John Wiley & Sons Ltd. Chichester
24. G.A. Stephenson, R.A. Forbes, and S.M. Reutzel-Edens Characterization of the solid state: quantitative issues Adv. Drug Delivery Rev. 48 2001 67 90 (Pubitemid 32452292)
25. C.J. Strachan, D. Pratiwi, K.C. Gordon, and T. Rades Quantitative analysis of polymorphic mixtures of carbamazepine by Raman spectroscopy and principal components analysis J. Raman Spectrosc. 35 2004 347 352
26. L.S. Taylor, and G. Zografi Spectroscopic characterization of interactions between PVP and indomethacin in amorphous molecular dispersions Pharm. Res. 14 1997 1691 1697
27. M. Tiwari, G. Chawla, and A.K. Bansal Quantification of olanzapine polymorphs using powder X-ray diffraction technique J. Pharm. Biomed. Anal. 43 2007 865 872 (Pubitemid 46185788)
28. H.H.Y. Tong, B.Y. Shekunov, J.P. Chan, C.K.F. Mok, H.C.M. Hung, and A.H.L. Chow An improved thermoanalytical approach to quantifying trace levels of polymorphic impurity in drug powders Int. J. Pharm. 295 2005 191 199 (Pubitemid 40558802)
29. H.H.Y. Tong, B.Y. Shekunov, P. York, and A.H.L. Chow Thermal analysis of trace levels of polymorphic impurity in salmeterol xinafoate samples Pharm. Res. 20 2003 1423 1429 (Pubitemid 37164051)
30. G. Vanden Poel, and V.B.F. Mathot High-speed/high performance differential scanning calorimetry (HPer DSC): temperature calibration in the heating and cooling mode and minimization of thermal lag Thermochim. Acta 446 2006 41 54 (Pubitemid 43867646)
31. M. Varasteh, Z. Deng, H. Hwang, Y.J. Kim, and G.B. Wong Quantitative determination of polymorphic impurity by X-ray powder diffractometry in an OROS formulation Int. J. Pharm. 366 2009 74 81
32. H.L. Wang, C.K. Mann, and T.J. Vickers Effect of powder properties on the intensity of Raman scattering by crystalline solids Appl. Spectrosc. 56 2002 1538 1544
33. R.D.G. Woolfenden Sulphamerazine K. Florey, Analytical Profiles of Drug Substances 1977 Academic Press New York
34. G.G.Z. Zhang, C. Gu, M.T. Zell, R. Todd Burkhardt, E.J. Munson, and D.J.W. Grant Crystallization and transitions of sulfamerazine polymorphs J. Pharm. Sci. 91 2002 1089 1100 (Pubitemid 34640934)