Podcast
Questions and Answers
Which factor does NOT affect drug dissolution?
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?
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?
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?
What is the purpose of a limit test in quality control?
Which parameter is NOT part of the dissolution testing conditions?
Which parameter is NOT part of the dissolution testing conditions?
What document contains compiled step-by-step instructions to help workers carry out routine operations?
What document contains compiled step-by-step instructions to help workers carry out routine operations?
Which document outlines a chemical's properties, including health, safety, fire, and environmental hazards?
Which document outlines a chemical's properties, including health, safety, fire, and environmental hazards?
What is the temperature maintained for Disintegration Testing of tablets?
What is the temperature maintained for Disintegration Testing of tablets?
Which term measures the force required to break a tablet under tension or bending load?
Which term measures the force required to break a tablet under tension or bending load?
What type of capsule has a thin, water insoluble clear membrane preventing the capsule fill from being released?
What type of capsule has a thin, water insoluble clear membrane preventing the capsule fill from being released?
What is the primary function of a Certificate of Analysis (COA)?
What is the primary function of a Certificate of Analysis (COA)?
Which of the following documents provides detailed specifications for pharmaceutical products?
Which of the following documents provides detailed specifications for pharmaceutical products?
Which factor is typically NOT included in a Material Safety Data Sheet (MSDS)?
Which factor is typically NOT included in a Material Safety Data Sheet (MSDS)?
What does UV-Vis analysis primarily measure in a sample?
What does UV-Vis analysis primarily measure in a sample?
Which method is used for purity determination that involves a solution of known concentration?
Which method is used for purity determination that involves a solution of known concentration?
What does the formula %P = (N x ml x mEq wt) / g (sample) calculate?
What does the formula %P = (N x ml x mEq wt) / g (sample) calculate?
What type of method uses calibrated instruments for determining sample purity?
What type of method uses calibrated instruments for determining sample purity?
What is a limit test designed to do in pharmaceutical analysis?
What is a limit test designed to do in pharmaceutical analysis?
What type of impurities does gross impurity include?
What type of impurities does gross impurity include?
Which of the following is NOT a characteristic of impurities in drug substances?
Which of the following is NOT a characteristic of impurities in drug substances?
Which type of analytical technique is UV-Vis analysis?
Which type of analytical technique is UV-Vis analysis?
What does a positive result in the Limulus Amebocyte Lysate test indicate?
What does a positive result in the Limulus Amebocyte Lysate test indicate?
Which method is NOT used for testing particulate matter?
Which method is NOT used for testing particulate matter?
In which stage of quality control are microbial assays for antibiotics typically performed?
In which stage of quality control are microbial assays for antibiotics typically performed?
What is the expected behavior of an O/W emulsion during a dilution test?
What is the expected behavior of an O/W emulsion during a dilution test?
What does the conductivity test for emulsions reveal about O/W emulsions?
What does the conductivity test for emulsions reveal about O/W emulsions?
Which type of dye will dissolve in the aqueous phase of an O/W emulsion during the dye solubility test?
Which type of dye will dissolve in the aqueous phase of an O/W emulsion during the dye solubility test?
What is the primary purpose of the Limulus Amebocyte Lysate test?
What is the primary purpose of the Limulus Amebocyte Lysate test?
For which type of product is the dialysis test most appropriate?
For which type of product is the dialysis test most appropriate?
What does the shelf life of a product indicate?
What does the shelf life of a product indicate?
What type of equipment is used for stability testing?
What type of equipment is used for stability testing?
Which of the following methods measures the extent and rate of solution formation from a solid dosage form?
Which of the following methods measures the extent and rate of solution formation from a solid dosage form?
What is the purpose of conducting dissolution testing on tablets?
What is the purpose of conducting dissolution testing on tablets?
What is measured when assessing the physical strength of a tablet?
What is measured when assessing the physical strength of a tablet?
Which parameter is assessed through long-term stability testing?
Which parameter is assessed through long-term stability testing?
In the context of drug stability, which condition is NOT usually simulated in a stability chamber?
In the context of drug stability, which condition is NOT usually simulated in a stability chamber?
What characteristics do environmental chambers for stability testing NOT simulate?
What characteristics do environmental chambers for stability testing NOT simulate?
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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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