title: Feasibility studies. The use of NMR spectrometry as a possible substitute of or complement to several analytical tests in pharmacopoeia monographs.
abstract: NMR spectrometry has many analytical applications; for instance, the identification of known substances; the structure elucidation of unknown ones; the quantification of APIs, impurities, solvent and water; kinetic studies, stereochemistry determinations, and the analyses of complex mixtures as in metabonomics. NMR spectrometry has the potential to substitute or complement existing analyses that are performed on APIs. In this work, 4 different NMR analyses were done on 2 APIs: fluvastatin sodium and benzalkonium chloride with good results.
authors: Medical Products Agency, Uppsala, Sweden. ian.mcewen@mpa.se
authors: I
authors: I
authors: McEwen
authors: T
authors: T
authors: Arvidsson
mesh_terms: D001548:Benzalkonium Compounds / Q000302:isolation & purification / Q000592:standards*; D004340:Drug Contamination; D004355:Drug Stability; D005229:Fatty Acids, Monounsaturated / Q000302:isolation & purification / Q000592:standards*; D005240:Feasibility Studies; D000077340:Fluvastatin; D007211:Indoles / Q000302:isolation & purification / Q000592:standards*; D009682:Magnetic Resonance Spectroscopy / Q000295:instrumentation / Q000379:methods* / Q000592:standards*; D015394:Molecular Structure; D010602:Pharmacopoeias as Topic / Q000592:standards; D011522:Protons; D014867:Water / Q000032:analysis
chemical_list: D001548:Benzalkonium Compounds; D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D011522:Protons; D014867:Water; D000077340:Fluvastatin