Podcast
Questions and Answers
What does repeatability in precision refer to?
What does repeatability in precision refer to?
What is the main purpose of quantitative analysis?
What is the main purpose of quantitative analysis?
Which of the following is NOT a limitation of titrimetric analysis methods?
Which of the following is NOT a limitation of titrimetric analysis methods?
What does the accuracy of a measurement refer to?
What does the accuracy of a measurement refer to?
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Which testing apparatus would be used to assess the disintegration of tablets?
Which testing apparatus would be used to assess the disintegration of tablets?
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In UV and visible spectroscopy, what happens to electrons in the solution during testing?
In UV and visible spectroscopy, what happens to electrons in the solution during testing?
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What is the primary advantage of titrimetric analysis methods?
What is the primary advantage of titrimetric analysis methods?
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Before formal formulation in drug development, which stage is critical?
Before formal formulation in drug development, which stage is critical?
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What is the primary principle behind infrared (IR) spectrometry?
What is the primary principle behind infrared (IR) spectrometry?
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Which limitation is associated with mass spectrometry?
Which limitation is associated with mass spectrometry?
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What method does chromatography exploit for separating components of a mixture?
What method does chromatography exploit for separating components of a mixture?
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Which application is NOT typically associated with high performance liquid chromatography (HPLC)?
Which application is NOT typically associated with high performance liquid chromatography (HPLC)?
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Which characteristic of IR spectrometry makes it particularly useful despite its limitations?
Which characteristic of IR spectrometry makes it particularly useful despite its limitations?
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What is a key strength of high performance liquid chromatography?
What is a key strength of high performance liquid chromatography?
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What does an immunoassay rely on for analysis?
What does an immunoassay rely on for analysis?
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What is the main purpose of the extraction process in sample preparation?
What is the main purpose of the extraction process in sample preparation?
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Which statement accurately describes the field of bioanalytical science?
Which statement accurately describes the field of bioanalytical science?
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Which of the following is a common limitation of chromatography?
Which of the following is a common limitation of chromatography?
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What type of analysis is focused on determining the amounts and proportions of chemical constituents?
What type of analysis is focused on determining the amounts and proportions of chemical constituents?
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Precision refers to the closeness of a measurement to the true value.
Precision refers to the closeness of a measurement to the true value.
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What apparatus is used for assessing tablet friability?
What apparatus is used for assessing tablet friability?
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The ______ method uses radiation in the wavelength of 200 - 700 nm to analyze solutions.
The ______ method uses radiation in the wavelength of 200 - 700 nm to analyze solutions.
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Match each type of analysis with its definition:
Match each type of analysis with its definition:
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Reformulation occurs after formal formulation in drug development.
Reformulation occurs after formal formulation in drug development.
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What is one advantage of titrimetric analysis methods?
What is one advantage of titrimetric analysis methods?
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What is a major strength of mass spectrometry?
What is a major strength of mass spectrometry?
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High performance liquid chromatography (HPLC) generates significant quantities of organic solvent waste.
High performance liquid chromatography (HPLC) generates significant quantities of organic solvent waste.
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What is the primary function of an immunoassay?
What is the primary function of an immunoassay?
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Chromatography exploits the differences in how analytes partition between a __________ phase and a stationary phase.
Chromatography exploits the differences in how analytes partition between a __________ phase and a stationary phase.
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Match the analytical techniques with their primary applications:
Match the analytical techniques with their primary applications:
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Which of the following limitations is associated with IR spectrometry?
Which of the following limitations is associated with IR spectrometry?
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In gas chromatography, the analyte is separated based on its mass to charge ratio.
In gas chromatography, the analyte is separated based on its mass to charge ratio.
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What is one common method of extraction used in pretreatment for analysis?
What is one common method of extraction used in pretreatment for analysis?
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Mass spectrometry utilizes __________ or electron ionization to generate charged species from analytes.
Mass spectrometry utilizes __________ or electron ionization to generate charged species from analytes.
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Which phase in chromatography is responsible for the separation of mixture components?
Which phase in chromatography is responsible for the separation of mixture components?
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Study Notes
Dosage Form Testing
- Various tests exist for different dosage forms (e.g., tablets, creams)
- Examples include disintegration, friability, hardness, and dissolution testing.
- Specific apparatus used for each test.
- Examples of tests include disintegration, friability, hardness, dissolution, and rheology (for creams).
Quality of Medicine Analysis
- Medicine quality may deviate from standards.
- Ensure quality of analysis is also up to standard.
- This is crucial.
- Quality management aspects include stability testing, impurity analysis, and residual solvent testing.
Drug and Dosage Form Development
- Reformulation is a stage in the development process prior to formal formulation.
Quantitative Analysis
- Determines amounts and proportions of chemical constituents in a substance.
Qualitative Analysis
- Identifies the nature of chemical constituents in a substance.
Accuracy and Precision
- Accuracy: Closeness to true value
- Precision: Closeness of multiple measurements
- Repeatability, intermediate precision, and reproducibility are levels of precision.
Titrimetric and Chemical Analysis Methods
- Analyte reacts with a standard reagent to assess sample purity.
- Applications include drug, excipient, and formulation assay.
- Can also be used for specialized applications (e.g., Karl Fischer).
- Strengths: High precision, accuracy, robustness, cost-effective, automatable.
- Limitations: Non-selective, requires skilled operator, high sample and reagent amounts.
UV-Vis Spectroscopy
- 200-700 nm radiation passes through a solution.
- Electrons absorb energy, changing to a higher quantum state.
- Loosely held electrons absorb longer wavelengths (less energy).
- Applications: Quantification, pKa, dissolution, solubility, release kinetics, reaction kinetics.
- Strengths: Easy use, cost-effective, robust, precise.
- Limitations: Moderate selectivity, not suitable for all solutes.
IR Spectroscopy
- EMR (400-4000 cm⁻¹) passes through a sample, interacting with bonds.
- Bonds stretch or bend, absorbing specific wavelengths.
- Applications: Qualitative analysis of excipients, drugs, compound identification, detecting polymorphisms (complex structures).
- Strengths: Unique "fingerprint" for compounds.
- Limitations: Not usually quantitative due to preparation constraints, limited usefulness for impurities.
Mass Spectrometry
- Analyte is ionized and accelerated to separate by mass-to-charge ratio (m/z).
- Applications: Drug identification, impurity characterisation, bioanalysis, proteomics.
- Strengths: Identifies and characterises molecules.
- Limitations: Expensive equipment, requires skilled personnel.
Chromatography
- Separates components in a mixture based on partitioning between mobile and stationary phases.
- Types: Column, thin layer, gas, high-performance liquid chromatography (HPLC).
- Related techniques: Capillary electrophoresis
- Modes: Analytical (analysis), Preparative (purification).
High-Performance Liquid Chromatography (HPLC)
- Liquid mobile phase under pressure runs through a column with stationary phase particles.
- Separation occurs based on time spent in stationary phase.
- Applications: Quantification of drugs/excipients, stability monitoring, biological sample analysis.
- Strengths: High analytical performance, versatile, automatable.
- Limitations: Sample preparation needed, solvent waste.
Bioanalytical Science
- Applies biological sciences to analyze biological samples.
- Large global industry.
Immunoassay
- Bioanalytical technique using antibody-antigen reactions.
- Measures and identifies molecules (drugs, biomolecules, metabolites).
Bioanalysis
- Quantifies drugs, metabolites, biological molecules in biological systems.
Pretreatment in Analysis
- Analytes removed from formulation matrices or biological matrices (e.g., blood).
- Examples include solvent extraction, solid-phase extraction.
- Critical for precision and accuracy.
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Description
This quiz covers key concepts in pharmaceutical analysis and dosage form testing, including methods of qualitative and quantitative analysis, accuracy, and precision. It also discusses the importance of testing various dosage forms and ensuring medicine quality. Deepen your understanding of drug development processes through this comprehensive assessment.