Abstract

Keywords: (1)H NMR; (13)C NMR; 1,1,1,3,3,3-hexafluoroisopropanol; 1,1,2-trichloro ethane; 13 carbon nuclear magnetic resonance spectroscopy; 1D/2D NMR; 3,4-methylenedioxy-N-methylamphetamine; AAMRT; ACN; APCI-MS; API; Analytical perspectives; BADGE; BEH; C(6)H(6); CAD; CCD; CCl(4); CE; CEAD; CH(2)Cl(2); CH(3)COONH(4); CHCl(2)CH(2)Cl; CHCl(3); CID; CO(2); COPD; DAD/MS; DEPT; Drug products; EDTA; ELSD; EMEA; ESI-CID-MS/MS; ESI-FTICR-MS; ESI/MS(n); European agency for the evaluation of medicinal products; FT-IR; FTICR; Forced degradation profiling; Fourier transform infrared; Fourier transform ion cyclotron resonance; GC-FID; GC–MS; GFC; GTIs; H(2)O; H(3)PO(4); HCOOH; HCOONH(4); HCl; HEIP; HILIC; HP-SEC; HPAE-IPAD; HPLC; HPLC/ESI-MS; HPTLC; ICH; IFM; IND; IPA; Impurity; International Conference on Harmonization; K(2)HPO(4); KH(2)PO(4); KOH; LC/MS/MS; LC–ESI-MS(n); LC–ESI-QT/MS/MS; LC–MS; LiCl; MDMA; MECC; MEKC; MPLC; MPTP; MS; MeOH; N-methyl-4-phenyl-1,2,3,6-tetrahydropyridine; NDA; NH(3); NH(4)H(2)PO(4); NH(4)OH; NOESY; NSAIDs; Na(2)HPO(4); Na(3)PO(4); NaCl; New Drug Application; OVIs; PCA; PDA; PDA-MS; PFPA; Q-TOF; RI; RRF; SDS; SDS-PAGE; SFC; SPME; TEA; TFA; Tris; UPLC; US Food and Drug Administration; USFDA; acetonitrile; active pharmaceutical ingredient; ammonia; ammonium acetate; ammonium dihydrogen phosphate; ammonium formate; ammonium hydroxide; atmospheric-pressure chemical-ionization mass spectrometry; auto-associative multivariate regression trees; benzene; bisphenol A diglycidyl ether; bridged ethylene hybrid; capillary electrophoresis; carbon dioxide; central composite design; charged aerosol detector; chloroform; chronic obstructive pulmonary disease; collision-induced dissociation; coulometric electrode array detection; diode array detector-mass spectrometry; dipotassium hydrogen phosphate; disodium phosphate; distortionless enhancement by polarization transfer; electronspray ionization multi-stage or tandem mass spectrometry; electrospray ionization Fourier transform ion cyclotron resonance mass spectrometry; electrospray ionization, collision-induced dissociation and tandem mass spectrometry; ethylene diamine tetra acetic acid; evaporative light scattering detector; formic acid; gas chromatography-flame ionization detector; gas chromatography–mass spectrometry; gel filtration chromatography; genotoxic impurities; headspace solid phase microextraction; high performance liquid chromatography; high performance thin layer chromatography; high-performance anion-exchange chromatography-integrated pulsed amperometric detection; high-performance liquid chromatography/electrospray ionization mass spectrometry; high-performance size-exclusion chromatography; hydrochloric acid; hydrophilic interaction chromatography; impurity fate mapping; investigational new drugs; isoproyl alcohol; liquid chromatography–electro spray ionization-tandem mass spectrometer; liquid chromatography–mass spectrometry; liquid chromatography–tandem mass spectrometry; liquid chromatography–tandem mass spectrometry using electrospray ionization source and Q-trap mass analyzer; lithium chloride; mass spectrometry; medium pressure liquid chromatography; methanol; methylene chloride; micellar electrokinetic capillary chromatography; micellar electrokinetic chromatography; non-steroidal anti-inflammatory drugs; nuclear overhauser effect spectroscopy; one dimensional/two dimensional nuclear magnetic resonance; organic volatile impurities; pentafluoropropionic acid anhydride; phosphoric acid; photodiode array; photodiode array detector-mass spectrometry; potassium dihydrogen phosphate; potassium hydroxide; principal component analysis; proton nuclear magnetic resonance spectroscopy; quadrupole-time-of-flight; refractive index; relative response factor; sodium chloride; sodium dodecyl sulfate; sodium dodecyl sulfate polyacrylamide gel electrophoresis; sodium phosphate; supercritical fluid chromatography; tetrachloromethane; triethylamine; trifluoroacetic acid; trisaminomethane; ultra performance liquid chromatography; water.