Stability and Shelf Life Quiz
42 Questions
4 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What is the definition of shelf life?

  • The time period in which a drug product is expected to remain within the approved specification if stored properly (correct)
  • The date after which a drug product should not be used
  • The time period in which a drug product is expected to reach 95% or 90% of the initial drug concentration
  • The extent to which a product retains the same properties and characteristics that it possessed at the time of its manufacture
  • What is the main concern regarding stability for a pharmacist?

  • Therapeutic effect and toxicity of the drug
  • Physical appearance and palatability of the drug
  • Resistance to microbial growth and sterility
  • Chemical integrity and labeled potency of the active ingredient (correct)
  • What does the term 't95 or t90' refer to in the context of shelf life?

  • The time period for which the drug retains its physical properties
  • The time period after which the drug should not be used
  • The time to reach 95% or 90% of the initial drug concentration (correct)
  • The time for which the drug stays sterile
  • What is the impact of opening a drug product on its expiry date?

    <p>The expiry date will be shorter</p> Signup and view all the answers

    Which factor can affect the stability of a pharmaceutical product?

    <p>Ionic strength</p> Signup and view all the answers

    Which functional groups are most commonly involved in hydrolysis?

    <p>Esters, amides, and lactams</p> Signup and view all the answers

    What is the most common mechanism of degradation for pharmaceutical products?

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

    Which compounds are likely to experience epimerization?

    <p>Tetracycline families</p> Signup and view all the answers

    What do antioxidants do to preserve the stability of a drug?

    <p>Provide electrons and easily available hydrogen atoms</p> Signup and view all the answers

    Which wavelengths tend to be the most damaging in photochemical decomposition?

    <p>300-400 nm</p> Signup and view all the answers

    What is the chemical breakdown of a compound with water called?

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

    Which functional group is aspirin hydrolyzed to in the presence of moisture?

    <p>Acetic acid and salicylic acid</p> Signup and view all the answers

    What are the most likely molecular structures to oxidize?

    <p>Phenol derivatives, conjugated dienes, and heterocyclic aromatic rings</p> Signup and view all the answers

    What is the loss of electrons from an atom or a molecule called?

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

    What do chelating agents contribute to the prevention of?

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

    What do amide bonds hydrolyze slower than?

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

    Which factor is not a contributor to the prevention of hydrolysis in pharmaceutical products?

    <p>Exclusion of oxygen</p> Signup and view all the answers

    What is the impact of autoclaving on the hydrolysis of pharmaceutical products?

    <p>It accelerates hydrolysis</p> Signup and view all the answers

    Which functional group is most likely to undergo epimerization?

    <p>Tetracycline families</p> Signup and view all the answers

    What is the primary mechanism of degradation for pharmaceutical products?

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

    Which type of compounds are likely to experience autoxidation at ambient temperature?

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

    What is the role of antioxidants in preserving the stability of drugs?

    <p>They divert the oxidative process</p> Signup and view all the answers

    Which wavelength range tends to be the most damaging in photochemical decomposition?

    <p>300-400 nm</p> Signup and view all the answers

    Which type of compounds are most likely to undergo dehydration, resulting in loss of antibacterial activity and toxicity?

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

    What is the primary role of chelating agents in the prevention of degradation in pharmaceutical products?

    <p>Binding metal ions</p> Signup and view all the answers

    What is the chemical breakdown of a compound with water called?

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

    What is the loss of electrons from an atom or a molecule called?

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

    Which molecular structures are most likely to oxidize due to an increase in the number of carbon-to-oxygen bonds?

    <p>Phenol derivatives</p> Signup and view all the answers

    What does the term 't95 or t90' refer to in the context of shelf life?

    <p>The time to reach 95% or 90% of the initial drug concentration</p> Signup and view all the answers

    What is the primary concern of a pharmacist regarding stability?

    <p>Chemical integrity and labeled potency of the active ingredient</p> Signup and view all the answers

    What is the role of antioxidants in preserving the stability of drugs?

    <p>To prevent oxidation of the drug</p> Signup and view all the answers

    What is the most common mechanism of degradation for pharmaceutical products?

    <p>Chemical degradation of the active ingredient</p> Signup and view all the answers

    What is the definition of shelf life?

    <p>The time period in which a drug product remains within approved specifications</p> Signup and view all the answers

    Which factor can affect the stability of a pharmaceutical product?

    <p>Exposure to extreme temperatures</p> Signup and view all the answers

    What is the impact of opening a drug product on its expiry date?

    <p>The expiry date is shortened</p> Signup and view all the answers

    What is the impact of autoclaving on the hydrolysis of pharmaceutical products?

    <p>It can accelerate hydrolysis</p> Signup and view all the answers

    Which type of compounds are most likely to undergo dehydration, resulting in loss of antibacterial activity and toxicity?

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

    What do chelating agents contribute to the prevention of?

    <p>Chemical degradation</p> Signup and view all the answers

    Which molecular structures are most likely to oxidize due to an increase in the number of carbon-to-oxygen bonds?

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

    Which wavelength range tends to be the most damaging in photochemical decomposition?

    <p>UV-C (100-280 nm)</p> Signup and view all the answers

    Maximum stability occurred at what pH at room temperature for hydrolysis?

    <p>pH 6</p> Signup and view all the answers

    Oxidation that takes place at ambient temp and involves molecular oxygen is?

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

    Study Notes

    Definition of Shelf Life

    • Shelf life refers to the length of time a drug product remains effective and safe for use under specified storage conditions.

    Main Concerns for Pharmacists

    • Pharmacists prioritize the stability of medications to ensure their safety, efficacy, and quality throughout their shelf life.

    t95 or t90

    • t95 or t90 indicate the time required for a pharmaceutical product's potency to decrease to 95% or 90% of its initial value, respectively.

    Impact of Opening Drug Products

    • Opening a drug product often accelerates degradation processes, potentially shortening its shelf life and moving towards its expiry date.

    Factors Affecting Stability

    • Several factors influence the stability of pharmaceutical products, including temperature, humidity, light exposure, and chemical composition.

    Common Functional Groups in Hydrolysis

    • Functional groups such as esters and amides are most commonly involved in hydrolysis reactions.

    Common Mechanism of Degradation

    • Hydrolysis is the most prevalent mechanism of degradation for pharmaceutical products, involving the reaction of water with the compound.

    Compounds Experiencing Epimerization

    • Compounds with chiral centers, particularly those exhibiting stereochemistry, are likely to experience epimerization.

    Role of Antioxidants

    • Antioxidants help maintain the stability of a drug by preventing oxidation reactions that can lead to degradation.

    Damaging Wavelengths in Photochemical Decomposition

    • Wavelengths in the ultraviolet range are generally the most damaging and can trigger photochemical reactions resulting in drug degradation.

    Chemical Breakdown with Water

    • The breakdown of a compound in the presence of water is referred to as hydrolysis.

    Hydrolysis of Aspirin

    • Aspirin is hydrolyzed to produce salicylic acid and acetic acid when exposed to moisture.

    Structures Likely to Oxidize

    • Molecules containing multiple carbon-to-oxygen bonds, like alcohols and phenols, are more susceptible to oxidation.

    Loss of Electrons

    • Oxidation is the process that involves the loss of electrons from an atom or a molecule.

    Role of Chelating Agents

    • Chelating agents reduce or prevent metal ion-induced degradation by binding to metal ions that catalyze oxidative and hydrolytic reactions.

    Amide Bonds Hydrolysis

    • Amide bonds hydrolyze more slowly than ester bonds, making them more stable under similar conditions.

    Factors Preventing Hydrolysis

    • Factors like low humidity, stable temperature, and minimizing exposure to light are contributors to hydrolysis prevention.

    Impact of Autoclaving

    • Autoclaving can initiate or accelerate hydrolysis in pharmaceutical products due to increased temperatures and moisture levels.

    Functional Group Undergoing Epimerization

    • Hydroxyl groups on sugars are most likely to undergo epimerization, leading to different stereoisomers.

    Primary Mechanism of Degradation

    • Hydrolysis remains the primary degradation mechanism for various pharmaceutical compounds.

    Compounds Undergoing Autoxidation

    • Unsaturated fatty acids, certain pharmaceuticals, and organic compounds prone to oxidation can experience autoxidation at ambient temperatures.

    Antioxidants' Role

    • Antioxidants mitigate the effects of oxidation, thereby enhancing the stability of pharmaceuticals.

    Damaging Photochemical Wavelength Range

    • The ultraviolet light range, particularly UV-C, is identified as the most damaging for causing photodecomposition.

    Compounds Likely to Undergo Dehydration

    • Compounds with labile functional groups such as certain antibiotics may dehydrate, leading to reduced antibacterial activity and toxicity.

    Primary Role of Chelating Agents

    • Chelating agents primarily prevent degradation by forming stable complexes with metal ions that can catalyze degradation reactions.

    Summary of Hydrolysis

    • Hydrolysis involves the interaction of water and a chemical compound, leading to its breakdown.

    Oxidation Process

    • Oxidation involves the loss of electrons, which can destabilize pharmaceutical compounds.

    Molecular Structures and Oxidation

    • Increased carbon-to-oxygen bonds in molecular structures elevate the likelihood of oxidation reactions.

    Maximum Stability and pH

    • Maximum stability in hydrolysis typically occurs at a neutral to slightly alkaline pH around room temperature.

    Ambient Temperature Oxidation

    • Oxidation that occurs at ambient temperature and involves molecular oxygen is referred to as autoxidation.

    Studying That Suits You

    Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

    Quiz Team

    Description

    Test your knowledge of pharmaceutical shelf life with this quiz. Explore concepts such as expiration dating, shelf life specifications, and drug concentration decay over time. See how much you know about the factors that influence a drug product's shelf life and storage requirements.

    More Like This

    Pharmaceutical Stability Studies
    10 questions
    Pharmaceutical Stability
    38 questions
    Pharmaceutical Shelf Life and Stability
    37 questions
    Use Quizgecko on...
    Browser
    Browser