Measuring Elemental Impurities in Pharmaceuticals
portes grátis
Measuring Elemental Impurities in Pharmaceuticals
A Practical Guide
Thomas, Robert
Taylor & Francis Ltd
12/2021
502
Mole
Inglês
9781032240893
15 a 20 dias
453
Descrição não disponível.
Overview of the USP Mission. Traditional Heavy Metals Testing Under Chapter 231. The Process for Change? Proposed New Chatpers <232> <233> and <2232>. The Role/Mission of th eICH and EMA in Setting Global Standards for Elemental Impurities in Drug Products. The ICH/USP Alignment Process. Understanding PDE Limits Defined in Chapter <232> and <2232>. Speciated Form: When is it Required. Options for Compliance. Testing-based, Risk-based Approach. Anaylytical Procedures and Validation Protocols Described in Chapter <233>. Sample Preparation Procedures. Which Techniques are Suggested. Validation Protocols. J Values. Calibration. Drift. Detectability. Precision. Specificity. Accuracy. Ruggedness. Limit of Quantification. Linear Range. Comparison of Plasma Spectrochemical Techniques Defined in Chapter <233>. Guidance on what is the Most Appropriate Technique to use. Productivity Enhancement Tools. Regulatory Compliance. Is Your Laboratory Ready for the FDA?. 21CFR Prat 11 Qualification. Computer Systems Validation/Electronic Records. Fundamentals Principles of ICP-OES. Principles of Atomic Excitation/Emission. Sample Introduction. Plasma Source. Opticial Configurations. Solid State Detector Technology. Understanding Interferences. Fundamental Principles of ICP-MS. Principles of Ion Formation. Sample Introduction. Plasma Source. Interface Region. Ion Focusing System. Mass Analyzers. Ion Detection. Peak Measurement Protocol. Methods of Quantitation. Review of Interferences. Contamination Issues. Routine Maintenance. Alternative Sample Introduction Techniques. Trace Element Speciation. Glossary of Terms Used in ICP-MS. References. Final Thoughts, Useful Contact Information. Index.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Inductively Coupled Plasma Mass Spectrometry;Ion Optics;Elemental contaminants in pharmaceuticals;ICP Mass Spectrometer;Heavy Metals Test;Mass Analyzer;ICP-MS;Spray Chamber;ICP-OES;Sample Introduction System;Elemental contaminants in nutraceuticals;Mass Separation Device;Thomas Robert;Sample Preparation;Coupled Plasma Optical Emission Spectrometry;Plasma Torch;Analyte Ions;Cool Plasma Conditions;ICP;Double Pass Spray Chamber;Skimmer Cone;Concentric Nebulizer;Spectral Interferences;Ion Beam;ICP MS System;Nebulizer Gas Flow;Reaction Cell;Cross-flow Nebulizer;Interfering Ion;Cool Plasma;Elemental Impurities
Overview of the USP Mission. Traditional Heavy Metals Testing Under Chapter 231. The Process for Change? Proposed New Chatpers <232> <233> and <2232>. The Role/Mission of th eICH and EMA in Setting Global Standards for Elemental Impurities in Drug Products. The ICH/USP Alignment Process. Understanding PDE Limits Defined in Chapter <232> and <2232>. Speciated Form: When is it Required. Options for Compliance. Testing-based, Risk-based Approach. Anaylytical Procedures and Validation Protocols Described in Chapter <233>. Sample Preparation Procedures. Which Techniques are Suggested. Validation Protocols. J Values. Calibration. Drift. Detectability. Precision. Specificity. Accuracy. Ruggedness. Limit of Quantification. Linear Range. Comparison of Plasma Spectrochemical Techniques Defined in Chapter <233>. Guidance on what is the Most Appropriate Technique to use. Productivity Enhancement Tools. Regulatory Compliance. Is Your Laboratory Ready for the FDA?. 21CFR Prat 11 Qualification. Computer Systems Validation/Electronic Records. Fundamentals Principles of ICP-OES. Principles of Atomic Excitation/Emission. Sample Introduction. Plasma Source. Opticial Configurations. Solid State Detector Technology. Understanding Interferences. Fundamental Principles of ICP-MS. Principles of Ion Formation. Sample Introduction. Plasma Source. Interface Region. Ion Focusing System. Mass Analyzers. Ion Detection. Peak Measurement Protocol. Methods of Quantitation. Review of Interferences. Contamination Issues. Routine Maintenance. Alternative Sample Introduction Techniques. Trace Element Speciation. Glossary of Terms Used in ICP-MS. References. Final Thoughts, Useful Contact Information. Index.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Inductively Coupled Plasma Mass Spectrometry;Ion Optics;Elemental contaminants in pharmaceuticals;ICP Mass Spectrometer;Heavy Metals Test;Mass Analyzer;ICP-MS;Spray Chamber;ICP-OES;Sample Introduction System;Elemental contaminants in nutraceuticals;Mass Separation Device;Thomas Robert;Sample Preparation;Coupled Plasma Optical Emission Spectrometry;Plasma Torch;Analyte Ions;Cool Plasma Conditions;ICP;Double Pass Spray Chamber;Skimmer Cone;Concentric Nebulizer;Spectral Interferences;Ion Beam;ICP MS System;Nebulizer Gas Flow;Reaction Cell;Cross-flow Nebulizer;Interfering Ion;Cool Plasma;Elemental Impurities
