tools of analysis of drug and medicines

• Why is quality control important in industrial processes?

  It ensures the quality of medicines
• What are the types of analysis mentioned?

  • Chemical
  • Physical
  • Microbiological
• What must be ensured about the quality of analysis?

  It must be of a suitable standard
• What are the applications of analysis in pharmaceuticals?

  • Bioanalysis
  • Dosage form attribute testing
  • Drug isolation
  • Quality testing
  • Drug identification
  • Drug characterisation
  • Stability testing
  • Compatibility testing
• Why is quality control important in industrial processes?

  It ensures the quality of medicines
• What are examples of scientific tools in R&D?

  • Microscopy
  • ELISA
  • Flow cytometry
  • Electrophysiology
  • Bioassay
  • Molecular diagnostics
  • Proteomics
  • Cell culture
  • Pre-clinical animal models
• What are the types of analysis mentioned?

  • Chemical
  • Physical
  • Microbiological
• What is preformulation in drug development?

  Stage before formal formulation
• What must be ensured about the quality of analysis?

  It must be of a suitable standard
• What do QA and QC departments focus on?

  • Quality
  • Safety
  • Purity
  • Effectiveness of drug products
• What are the applications of analysis in pharmaceuticals?

  • Bioanalysis
  • Dosage form attribute testing
  • Drug isolation
  • Quality testing
  • Drug identification
  • Drug characterisation
  • Stability testing
  • Compatibility testing
• What is a specification in quality management?

  List of tests and acceptance criteria
• What are example tests in quality management?

  • Stability
  • Impurities
  • Residual solvent
• What is preformulation in drug development?

  Stage before formal formulation
• What are examples of dosage form testing?

  • Tablets: Disintegration, friability, hardness, dissolution
  • Cream: Rheology testing
• What do QA and QC departments focus on?

  • Quality
  • Safety
  • Purity
  • Effectiveness of drug products
• What are the types of analysis in pharmaceutical science?

  • Qualitative analysis: Nature of constituents
  • Quantitative analysis: Amounts and proportions of constituents
• What is a specification in quality management?

  List of tests and acceptance criteria
• What does accuracy refer to in analytical procedures?

  Closeness to the true value
• What does precision refer to in analytical procedures?

  Closeness of multiple measurements to each other
• What are the levels of precision?

  • Repeatability
  • Intermediate precision
  • Reproducibility
• What can cause inaccuracies and imprecisions in analysis?

  Random and systematic errors
• What are common terminologies in analysis?

  • Analytical blank
  • Calibration
  • Limit of detection
  • Limit of quantification
  • Linearity
  • Range
  • Robustness
  • Selectivity
  • Sensitivity
  • Weight by difference
• What is the principle of titrimetric analysis?

  • Analyte reacts with a standard solution
  • Used to estimate purity of a sample
• What are the advantages of titrimetric analysis?

  • High precision
  • Accuracy
  • Robust
  • Cheap
  • Automatable
  • No calibration needed
• What are example tests in quality management?

  • Stability
  • Impurities
  • Residual solvent
• What are the limitations of titrimetric analysis?

  • Non-selective
  • Requires skilled operator
  • Large sample and reagent amounts
• What are examples of dosage form testing?

  • Tablets: Disintegration, friability, hardness, dissolution
  • Cream: Rheology testing
• What is spectroscopy?

  Study of interaction between EMR and molecules
• What are the types of analysis in pharmaceutical science?

  • Qualitative analysis: Nature of constituents
  • Quantitative analysis: Amounts and proportions of constituents
• What is the principle of ultraviolet and visible spectroscopy?

  Radiation passes through a solution, exciting electrons
• What does accuracy refer to in analytical procedures?

  Closeness to the true value
• What are the applications of ultraviolet and visible spectroscopy?

  • Quantification
  • pKa determination
  • Dissolution studies
  • Reaction kinetics
• What does precision refer to in analytical procedures?

  Closeness of multiple measurements to each other
• What are the strengths of ultraviolet and visible spectroscopy?

  • Easy to use
  • Cheap
  • Robust
  • Precision
• What are the limitations of ultraviolet and visible spectroscopy?

  • Moderate selectivity
  • Not applicable to all solutes
• What can cause inaccuracies and imprecisions in analysis?

  Random and systematic errors
• What is the principle of IR spectrometry?

  EMR is absorbed by molecular bonds causing stretching
• What are the applications of IR spectrometry?

  • Qualitative fingerprint checks
  • Preliminary compound identification
  • Analysis in complex environments
• What are the strengths of IR spectrometry?

  • Unique complex fingerprint