Pharmaceutical Analysis and Testing Techniques
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Questions and Answers

What does repeatability in precision refer to?

  • Variation in measurements when different operators perform them
  • Consistency of measurements over different conditions
  • Similarity of results obtained from different instruments
  • Closeness of multiple measurements from the same sample (correct)
  • What is the main purpose of quantitative analysis?

  • To measure the physical properties of a substance
  • To enhance the speed of test results
  • To ascertain the nature of chemical constituents
  • To determine the amounts and proportions of substances (correct)
  • Which of the following is NOT a limitation of titrimetric analysis methods?

  • Requires large sample volumes
  • Requires skilled operators
  • High calibration requirements (correct)
  • Non-selectivity
  • What does the accuracy of a measurement refer to?

    <p>The closeness to the true value (A)</p> Signup and view all the answers

    Which testing apparatus would be used to assess the disintegration of tablets?

    <p>Disintegration apparatus (D)</p> Signup and view all the answers

    In UV and visible spectroscopy, what happens to electrons in the solution during testing?

    <p>They become excited and occupy a higher quantum state (D)</p> Signup and view all the answers

    What is the primary advantage of titrimetric analysis methods?

    <p>High precision and accuracy (A)</p> Signup and view all the answers

    Before formal formulation in drug development, which stage is critical?

    <p>Reformulation stage (D)</p> Signup and view all the answers

    What is the primary principle behind infrared (IR) spectrometry?

    <p>It involves the absorption of electromagnetic radiation by molecular bonds. (C)</p> Signup and view all the answers

    Which limitation is associated with mass spectrometry?

    <p>High operational costs and requires specialized training. (B)</p> Signup and view all the answers

    What method does chromatography exploit for separating components of a mixture?

    <p>Differences in solubility in mobile and stationary phases. (B)</p> Signup and view all the answers

    Which application is NOT typically associated with high performance liquid chromatography (HPLC)?

    <p>Detection of gross impurities. (D)</p> Signup and view all the answers

    Which characteristic of IR spectrometry makes it particularly useful despite its limitations?

    <p>It provides a complex fingerprint unique to the compound. (D)</p> Signup and view all the answers

    What is a key strength of high performance liquid chromatography?

    <p>Strong performance in multiple analytical metrics. (C)</p> Signup and view all the answers

    What does an immunoassay rely on for analysis?

    <p>The sensitivity of antibody-antigen interactions. (C)</p> Signup and view all the answers

    What is the main purpose of the extraction process in sample preparation?

    <p>To remove interfering substances from the sample matrix. (C)</p> Signup and view all the answers

    Which statement accurately describes the field of bioanalytical science?

    <p>It encompasses the application of biological sciences to analyze various biological samples. (A)</p> Signup and view all the answers

    Which of the following is a common limitation of chromatography?

    <p>Challenges in separating complex mixtures. (A)</p> Signup and view all the answers

    What type of analysis is focused on determining the amounts and proportions of chemical constituents?

    <p>Quantitative Analysis (C)</p> Signup and view all the answers

    Precision refers to the closeness of a measurement to the true value.

    <p>False (B)</p> Signup and view all the answers

    What apparatus is used for assessing tablet friability?

    <p>Friabilator</p> Signup and view all the answers

    The ______ method uses radiation in the wavelength of 200 - 700 nm to analyze solutions.

    <p>UV and visible spectroscopy</p> Signup and view all the answers

    Match each type of analysis with its definition:

    <p>Qualitative Analysis = Determines the nature of chemical constituents Quantitative Analysis = Determines the amounts of chemical constituents Accuracy = Closeness to the true value Precision = Closeness of multiple measurements to each other</p> Signup and view all the answers

    Reformulation occurs after formal formulation in drug development.

    <p>False (B)</p> Signup and view all the answers

    What is one advantage of titrimetric analysis methods?

    <p>High precision</p> Signup and view all the answers

    What is a major strength of mass spectrometry?

    <p>Quantification of drug metabolites (D)</p> Signup and view all the answers

    High performance liquid chromatography (HPLC) generates significant quantities of organic solvent waste.

    <p>True (A)</p> Signup and view all the answers

    What is the primary function of an immunoassay?

    <p>Qualitative and quantitative analysis of analytes</p> Signup and view all the answers

    Chromatography exploits the differences in how analytes partition between a __________ phase and a stationary phase.

    <p>mobile</p> Signup and view all the answers

    Match the analytical techniques with their primary applications:

    <p>IR Spectrometry = Qualitative fingerprint check Chromatography = Separation of mixture components Mass Spectrometry = Drug identification Immunoassay = Analyte analysis using antibodies</p> Signup and view all the answers

    Which of the following limitations is associated with IR spectrometry?

    <p>Only detects gross impurities (B)</p> Signup and view all the answers

    In gas chromatography, the analyte is separated based on its mass to charge ratio.

    <p>False (B)</p> Signup and view all the answers

    What is one common method of extraction used in pretreatment for analysis?

    <p>Solvent extraction</p> Signup and view all the answers

    Mass spectrometry utilizes __________ or electron ionization to generate charged species from analytes.

    <p>chemical ionization</p> Signup and view all the answers

    Which phase in chromatography is responsible for the separation of mixture components?

    <p>Stationary phase (A)</p> Signup and view all the answers

    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.

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