Publication | Closed Access
Test Procedure Validation for the TLC Assay of a Degradation Product in a Pharmaceutical Formulation
23
Citations
6
References
1994
Year
Method ValidationDrug PurityTlc AssayBioanalysisPharmacologyValidation ApproachProcess Analytical TechnologyDegradation ProductAnalytical ChemistryToxicologyBiostatisticsLiquid ChromatographyClinical ChemistryTest Procedure ValidationChromatographic AnalysisMedicineChromatographyDrug Analysis
Abstract An experimental and statistical approach for validating the TLC assay of a degradation product in a pharmaceutical formulation is given. This validation approach is intended to take into account the main particular aspects of the technique.
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