42 Questions
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
What is the main concern regarding stability for a pharmacist?
Chemical integrity and labeled potency of the active ingredient
What does the term 't95 or t90' refer to in the context of shelf life?
The time to reach 95% or 90% of the initial drug concentration
What is the impact of opening a drug product on its expiry date?
The expiry date will be shorter
Which factor can affect the stability of a pharmaceutical product?
Ionic strength
Which functional groups are most commonly involved in hydrolysis?
Esters, amides, and lactams
What is the most common mechanism of degradation for pharmaceutical products?
Oxidation
Which compounds are likely to experience epimerization?
Tetracycline families
What do antioxidants do to preserve the stability of a drug?
Provide electrons and easily available hydrogen atoms
Which wavelengths tend to be the most damaging in photochemical decomposition?
300-400 nm
What is the chemical breakdown of a compound with water called?
Hydrolysis
Which functional group is aspirin hydrolyzed to in the presence of moisture?
Acetic acid and salicylic acid
What are the most likely molecular structures to oxidize?
Phenol derivatives, conjugated dienes, and heterocyclic aromatic rings
What is the loss of electrons from an atom or a molecule called?
Oxidation
What do chelating agents contribute to the prevention of?
Oxidation
What do amide bonds hydrolyze slower than?
Esters
Which factor is not a contributor to the prevention of hydrolysis in pharmaceutical products?
Exclusion of oxygen
What is the impact of autoclaving on the hydrolysis of pharmaceutical products?
It accelerates hydrolysis
Which functional group is most likely to undergo epimerization?
Tetracycline families
What is the primary mechanism of degradation for pharmaceutical products?
Hydrolysis
Which type of compounds are likely to experience autoxidation at ambient temperature?
Ampicillin
What is the role of antioxidants in preserving the stability of drugs?
They divert the oxidative process
Which wavelength range tends to be the most damaging in photochemical decomposition?
300-400 nm
Which type of compounds are most likely to undergo dehydration, resulting in loss of antibacterial activity and toxicity?
Tetracycline
What is the primary role of chelating agents in the prevention of degradation in pharmaceutical products?
Binding metal ions
What is the chemical breakdown of a compound with water called?
Hydrolysis
What is the loss of electrons from an atom or a molecule called?
Oxidation
Which molecular structures are most likely to oxidize due to an increase in the number of carbon-to-oxygen bonds?
Phenol derivatives
What does the term 't95 or t90' refer to in the context of shelf life?
The time to reach 95% or 90% of the initial drug concentration
What is the primary concern of a pharmacist regarding stability?
Chemical integrity and labeled potency of the active ingredient
What is the role of antioxidants in preserving the stability of drugs?
To prevent oxidation of the drug
What is the most common mechanism of degradation for pharmaceutical products?
Chemical degradation of the active ingredient
What is the definition of shelf life?
The time period in which a drug product remains within approved specifications
Which factor can affect the stability of a pharmaceutical product?
Exposure to extreme temperatures
What is the impact of opening a drug product on its expiry date?
The expiry date is shortened
What is the impact of autoclaving on the hydrolysis of pharmaceutical products?
It can accelerate hydrolysis
Which type of compounds are most likely to undergo dehydration, resulting in loss of antibacterial activity and toxicity?
Esters
What do chelating agents contribute to the prevention of?
Chemical degradation
Which molecular structures are most likely to oxidize due to an increase in the number of carbon-to-oxygen bonds?
Alkenes
Which wavelength range tends to be the most damaging in photochemical decomposition?
UV-C (100-280 nm)
Maximum stability occurred at what pH at room temperature for hydrolysis?
pH 6
Oxidation that takes place at ambient temp and involves molecular oxygen is?
Autoxidation
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.
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