Pharmaceutical Analysis Techniques
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Questions and Answers

Which factor does NOT affect drug dissolution?

  • Particle size
  • Chemical stability in dissolution media
  • Surface area
  • Color of the tablet (correct)

    • What type of method confirms the identity of a sample using chemical reactions?

  • Chemical method (correct)
  • Physical method
  • Biological method
  • Spectroscopic method

    • Which of the following would enhance drug dissolution through its physical properties?

  • Increasing surface area (correct)
  • Increased particle size
  • Reducing agitation rate
  • Lowering pH

    • What is the purpose of a limit test in quality control?

    <p>To ensure impurity levels are within acceptable limits</p> Signup and view all the answers

    Which parameter is NOT part of the dissolution testing conditions?

    <p>Type of container used</p> Signup and view all the answers

    What document contains compiled step-by-step instructions to help workers carry out routine operations?

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

    Which document outlines a chemical's properties, including health, safety, fire, and environmental hazards?

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

    What is the temperature maintained for Disintegration Testing of tablets?

    <p>37 ± 0.2 °C</p> Signup and view all the answers

    Which term measures the force required to break a tablet under tension or bending load?

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

    What type of capsule has a thin, water insoluble clear membrane preventing the capsule fill from being released?

    <p>Enteric Capsule</p> Signup and view all the answers

    What is the primary function of a Certificate of Analysis (COA)?

    <p>To verify that a product meets specified standards</p> Signup and view all the answers

    Which of the following documents provides detailed specifications for pharmaceutical products?

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

    Which factor is typically NOT included in a Material Safety Data Sheet (MSDS)?

    <p>Testing procedures</p> Signup and view all the answers

    What does UV-Vis analysis primarily measure in a sample?

    <p>The absorption of UV or visible light</p> Signup and view all the answers

    Which method is used for purity determination that involves a solution of known concentration?

    <p>Titration method</p> Signup and view all the answers

    What does the formula %P = (N x ml x mEq wt) / g (sample) calculate?

    <p>The purity percentage of a sample</p> Signup and view all the answers

    What type of method uses calibrated instruments for determining sample purity?

    <p>Instrumental method</p> Signup and view all the answers

    What is a limit test designed to do in pharmaceutical analysis?

    <p>Control small quantities of impurities</p> Signup and view all the answers

    What type of impurities does gross impurity include?

    <p>Insoluble matter and dirt</p> Signup and view all the answers

    Which of the following is NOT a characteristic of impurities in drug substances?

    <p>They increase the shelf life of products</p> Signup and view all the answers

    Which type of analytical technique is UV-Vis analysis?

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

    What does a positive result in the Limulus Amebocyte Lysate test indicate?

    <p>Presence of endotoxins from gram-negative bacteria</p> Signup and view all the answers

    Which method is NOT used for testing particulate matter?

    <p>Gel Electrophoresis Particle Test</p> Signup and view all the answers

    In which stage of quality control are microbial assays for antibiotics typically performed?

    <p>Finished Product Quality Control</p> Signup and view all the answers

    What is the expected behavior of an O/W emulsion during a dilution test?

    <p>It can be diluted with water</p> Signup and view all the answers

    What does the conductivity test for emulsions reveal about O/W emulsions?

    <p>They cause the lamp to glow</p> Signup and view all the answers

    Which type of dye will dissolve in the aqueous phase of an O/W emulsion during the dye solubility test?

    <p>Water-soluble dye</p> Signup and view all the answers

    What is the primary purpose of the Limulus Amebocyte Lysate test?

    <p>To assess the presence of endotoxins</p> Signup and view all the answers

    For which type of product is the dialysis test most appropriate?

    <p>Liquid dosage forms</p> Signup and view all the answers

    What does the shelf life of a product indicate?

    <p>The duration the product will retain over 90% of its potency</p> Signup and view all the answers

    What type of equipment is used for stability testing?

    <p>Stability chamber</p> Signup and view all the answers

    Which of the following methods measures the extent and rate of solution formation from a solid dosage form?

    <p>Titrimetric method</p> Signup and view all the answers

    What is the purpose of conducting dissolution testing on tablets?

    <p>To evaluate the bioavailability and therapeutic effectiveness</p> Signup and view all the answers

    What is measured when assessing the physical strength of a tablet?

    <p>The force required to break the tablet</p> Signup and view all the answers

    Which parameter is assessed through long-term stability testing?

    <p>Active ingredient concentration over time</p> Signup and view all the answers

    In the context of drug stability, which condition is NOT usually simulated in a stability chamber?

    <p>Rapid temperature fluctuations</p> Signup and view all the answers

    What characteristics do environmental chambers for stability testing NOT simulate?

    <p>Biological activity of microorganisms</p> Signup and view all the answers

    Study Notes

    Chromatography & Spectroscopy

    • Chromatography and spectroscopy are essential techniques in pharmaceutical analysis for separate identification and quantification of substances.
    • Chromatography techniques include methods like HPLC for separating chemical mixtures based on their movement through a stationary phase.
    • Spectroscopy involves assessing the interaction between light and matter to determine the qualitative and quantitative qualities of compounds.

    Documents in Pharmaceutical Analysis

    • SOP (Standard Operating Procedures): Provides step-by-step instructions for routine operations.
    • MSDS (Material Safety Data Sheet): Contains information on a chemical's properties, health, safety, and environmental hazards.
    • COA (Certificate of Analysis): Details the results of tests performed on a specific batch of a product.
    • Monograph: A comprehensive description that includes specifications and tests for a substance.

    Disintegration & Dissolution Testing

    • Testing Temperature for Disintegration: Maintained at 37 ± 2 °C for optimal tablet testing.
    • Factors Affecting Drug Dissolution:
      • Drug substance properties: Particle size, polymorphism, chemical stability.
      • Medium characteristics: pH, temperature, co-solvents.
      • Formulation details: Excipients, placement in the vessel, and agitation rates.

    Quality Control Stages

    • Raw Materials Quality Control (RMQC): Ensures all materials meet required specifications before production.
    • Finished Product Quality Control (FPQC): Assesses the final product for quality assurance.
    • Packaging Material Quality Control (PMQC): Evaluates packaging to ensure safety and efficacy of products.

    Identification Tests

    • Chemical Methods: Utilize chemical reactions to confirm sample identity, often assessed through color change or precipitate formation.
    • HPLC and UV-Visible Spectroscopy: Analytical techniques measuring absorbance/transmission of light to identify compounds.

    Purity Tests

    • Assay via Titration: Involves adding a solution of known concentration to a sample until a reaction endpoint, commonly indicated by color change, is reached.
    • Calculating Purity:
      • %P = (N x ml x mEq wt) / g (sample) x 100
      • %P = [(ml x N) - (ml x N) x mEq wt] / g (sample) x 100
    • Instrumental Methods: Involving calibrated instruments for purity determination, including spectral and electroanalytical techniques.

    Limit Tests

    • Assess impurities that compromise drug safety and efficacy.
    • Gross Impurity: Involves tests like the Limulus Amebocyte Lysate (LAL) test to detect endotoxins from gram-negative bacteria.

    Stability Testing

    • Stability Chambers: Specialized equipment simulating storage conditions to evaluate drug stability via real-time and accelerated testing protocols.
    • Assessing Drug Stability: Parameters include dissolution and physical strength to ensure effective dosage formulations.

    Liquid Dosage Forms Testing

    • Dye Solubility Test: Determines emulsion types based on water (O/W) or oil (W/O) solubility of dyes.
    • Conductivity Test: Evaluates O/W emulsions; conductive liquids indicate emulsion type and compatibility.

    Key Terms

    • Disintegration Testing: Measures how quickly a tablet breaks apart in a specified condition, essential for efficacy.
    • Conductivity: Assesses emulsion type and stability based on electrical conduction performance.

    Important Notes

    • Ensure adherence to ASEAN guidelines for drug stability testing parameters.

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    Description

    This quiz covers essential techniques in pharmaceutical analysis such as chromatography and spectroscopy. You'll explore the various methods used for identifying and quantifying substances. Get familiar with important documents like SOPs and MSDS that are crucial for safety and compliance in the pharmaceutical field.

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