ADL Pellets Executive Ass Manager
2 weeks ago
- DefineObjectives andRequirements :Clearly outline the purpose of the analytical methods. Determinewhat parameters need to be measured such as assay potencyimpurities and dissolution profile. Understand regulatoryrequirements and industrystandards.
- LiteratureReview :Conduct a thorough literature review to understand existing methodsand technologies relevant to pellet formulation analysis. Identifyany gaps or areas forimprovement.
- MethodDevelopment :
- Selectappropriate analytical techniques based on the properties of thepellet formulation. Common techniques include HPLC (HighPerformanceLiquid Chromatography) GC (Gas Chromatography) UVVis spectroscopyetc.
- Optimizeconditions such as mobile phase composition column type temperatureetc. for eachmethod.
- Developmethods for impurity detection and quantification ensuringsensitivity andselectivity.
- Establishdissolution methods to assess the release profile of activeingredients from thepellets.
- Selectappropriate analytical techniques based on the properties of thepellet formulation. Common techniques include HPLC (HighPerformanceLiquid Chromatography) GC (Gas Chromatography) UVVis spectroscopyetc.
- MethodValidation :
- Conductmethod validation according to regulatory guidelines (e.g. ICHFDA).
- Validateparameters such as specificity accuracy precision linearityrobustness and limit of detection/quantitation for eachmethod.
- Performforced degradation studies to assess methodrobustness.
- Ensurevalidation protocols are welldocumented andreproducible.
- Conductmethod validation according to regulatory guidelines (e.g. ICHFDA).
- DocumentationandReporting :
- Documentall method development and validation activities in detailincluding protocols results and any deviationsencountered.
- Preparecomprehensive validation reports summarizing the methodologyresults andconclusions.
- Ensuredocumentation complies with regulatory standards and internalqualityprocedures.
- Documentall method development and validation activities in detailincluding protocols results and any deviationsencountered.
Proven expertise inHPLC, GC, dissolution testing and other analytical techniquescommonly used in pharma analysis.
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