Development of a new sodium diclofenac certified reference material using the mass balance approach and 1H qNMR to determine the certified property value

European Journal of Pharmaceutical Sciences

Volumn 48, Issue 3, 2013, Pages 502-513

  Nogueira, Raquel ^a   Garrido, Bruno C ^a   Borges, Ricardo M ^b   Silva, Gisele E B ^a   Queiroz, Suzane M ^a   Cunha, Valnei S ^a  

^a INSTITUTO NACIONAL DE METROLOGIA   (Brazil)

^b FEDERAL UNIVERSITY OF RIO DE JANEIRO   (Brazil)

Author keywords

Active pharmaceutical ingredients (API); Analytical quality control; Certified reference materials (CRM); Metrological traceability; Sodium diclofenac

Indexed keywords

DICLOFENAC;

ACCURACY; ARTICLE; CARBON NUCLEAR MAGNETIC RESONANCE; CERTIFIED REFERENCE MATERIAL; CLINICAL PRACTICE; DRUG CONTROL; DRUG INDUSTRY; DRUG PURITY; DRUG QUALITY; DRUG STABILITY; DRUG STORAGE; INTERNATIONAL STANDARD UNIT; LABORATORY TEST; MATERIALS; MONTE CARLO METHOD; PRACTICE GUIDELINE; PRIORITY JOURNAL; STANDARD; BRAZIL; CHEMICAL STRUCTURE; CHEMISTRY; DRUG CONTAMINATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; ISOLATION AND PURIFICATION; LIMIT OF DETECTION; PHARMACEUTICS; PROTON NUCLEAR MAGNETIC RESONANCE; QUALITY CONTROL; REPRODUCIBILITY; STANDARDS; TRAFFIC AND TRANSPORT; ULTRAVIOLET SPECTROPHOTOMETRY; UNCERTAINTY; VALIDATION STUDY;

BRAZIL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DICLOFENAC; DRUG CONTAMINATION; DRUG STABILITY; DRUG STORAGE; GUIDELINES AS TOPIC; INTERNATIONAL SYSTEM OF UNITS; LIMIT OF DETECTION; MODELS, MOLECULAR; MONTE CARLO METHOD; PROTON MAGNETIC RESONANCE SPECTROSCOPY; QUALITY CONTROL; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SPECTROPHOTOMETRY, ULTRAVIOLET; TECHNOLOGY, PHARMACEUTICAL; TRANSPORTATION; UNCERTAINTY;

EID: 84872420598     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2012.11.005     Document Type: Article

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