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

Flashcards

Reformulation

A process that involves changing the composition of a drug or dosage form before the final formulation.

Qualitative Analysis

A method of analyzing a substance to identify the specific components that make it up.

Quantitative Analysis

A method of analyzing a substance to determine the exact quantities of each component.

Accuracy

The closeness of a measurement to the true value.

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Precision

The closeness of two or more measurements made under the same conditions.

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Titrimetric Analysis

A type of analysis where a known amount of a reagent is added to a solution of a substance to determine its concentration.

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UV-Vis Spectroscopy

A type of analysis that measures the absorption of ultraviolet or visible light by a substance.

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Chromatography

A technique that uses the interaction between an analyte and a stationary phase to separate and quantify components in a mixture.

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High Performance Liquid Chromatography (HPLC)

A type of chromatography where a liquid mobile phase carries the analyte through a packed column containing a stationary phase, separating components based on their affinity to each phase.

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Gas Chromatography (GC)

A technique that uses the interaction between an analyte and a mobile phase, typically a gas, to separate and analyze components in a mixture.

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Extraction

The removal of an analyte from a complex matrix, like a tablet or blood, to prepare it for analysis.

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Infrared (IR) Spectrum

A spectrum obtained by shining infrared radiation through a sample and measuring the amount of radiation absorbed by the molecules.

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Mass Spectrometry (MS)

A technique that measures the mass-to-charge ratio of ions, providing information about the molecular weight and structure of an analyte.

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Immunoassay

A bioanalytical technique that uses the highly specific interaction between an antibody and an antigen for the detection and quantification of analytes.

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Bioanalysis

The quantitative measurement of drugs, their metabolites, and other biomolecules in biological samples.

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pKa

A measure of the acidity of a molecule, indicating the tendency to donate a proton.

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Solubility

The ability of a substance to dissolve in a particular solvent.

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Rheology Testing

The study of how liquids flow and deform under stress.

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Pretreatment

The removal of analyte from materials in the formulation matrix or from complex biological matrices that could interfere in the analysis or impede instrument function.

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Infrared (IR) Spectroscopy

Electromagnetic radiation (EMR) between 400 cm-1 and 4000 cm-1 (2500 nm to 20000 nm) is passed through a sample and is absorbed by the bonds of the molecules in the sample.

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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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