This set of Pharmaceutical Biotechnology Multiple Choice Questions & Answers (MCQs) focuses on “Shelf Life”.
1. What do you mean Shelf life in Pharmaceuticals?
a) The length of duration taken for a drug to be manufactured
b) The length of duration taken for a drug to be delivered in the market from the time of its discovery and development
c) The time period in which the drug can be utilized as medicine from the time of its manufacturing under specific conditions
d) The time period in which a drug undergoes all four phases of clinical trials
View Answer
Explanation: Shelf life of a drug is typically the time period in which the drug can be stored and consumed for medicinal purposes, under specific predetermined conditions. It can also be defined as the time taken for a substance to reduce to 90% concentration.
2. The shelf life of a drug is commonly expressed in years.
a) True
b) False
View Answer
Explanation: The shelf life of a drug is generally expressed in months (like 6 months, 12 months or 24 months) and in most cases, the shelf life of a substance is given in terms of expiration date. Expiration date is the date after which the drug becomes unfit for utilization.
3. In general, for a new drug, how long will be its shelf life?
a) 6 months
b) 12 months
c) 18 months
d) 24 months
View Answer
Explanation: In general, the shelf life of a new drug is 24 months, which is determined based on its stability and the rate of decomposition of its active ingredient, besides other factors such as the ability to react with additives incorporated within the drug.
4. Which of the following testing method is predominantly used for determining shelf life of a drug product?
a) Cyclic Temperature Stress Testing
b) Real Time Testing
c) Retained Sample Testing
d) Accelerated Testing
View Answer
Explanation: Accelerated Testing is the most commonly used method for determining the shelf life of a drug product. In this testing method, the drugs are subjected to different temperatures in order to predict its decomposition rate.
5. Which of the following is the correct representation for Shelf life of a drug product?
a) t10
b) t90
c) t50
d) t0.5
View Answer
Explanation: The shelf life of a drug product is represented as t90, denoting the time required for the drug concentration to reduce to 90% from its original concentration. The shelf life of a drug product is given by t90 = \(\frac{0.105}{k}\), where k is the rate constant.
6. Some drug products are fit for usage even after their expiration dates.
a) True
b) False
View Answer
Explanation: In most cases, several drugs are fit to use, even after passing their dates of expiration. And this conclusion may vary based on the presence of active drug ingredients and other storage conditions. Hence, even though being fit for usage, it’s better to avoid using drugs beyond their expiration dates.
7. What is the shelf life of paracetamol, if not unsealed?
a) 2 months
b) 3 months
c) 2 years
d) 3 years
View Answer
Explanation: If not unsealed, Paracetamol can be utilized for two years, as long as they’re stored below the temperature of 30°C, without being exposed to direct sunlight. If opened, the shelf of the drug may reduce to 1 month.
8. Drugs have single shelf life.
a) True
b) False
View Answer
Explanation: It is evident that some drugs have two shelf lives because if the drugs are stored in dry conditions, they may have a relatively low longevity and when they are stored in lyophilized conditions, their shelf lives may get extended.
9. What is the correct abbreviation of ICH?
a) Indian Council for Human Research
b) Indian Council for Harmonization
c) International Council for Human Research
d) International Council for Harmonization
View Answer
Explanation: ICH can be abbreviated as International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. The ICH is primarily involved in providing guidelines for pharmaceutical industries to improve its standards for drug development.
10. How a drug’s shelf life is predicted using Arrhenius equation?
a) If the value of the activation energy is known then we can assume the stability of a product to determine the shelf life
b) By changing the concentration of active ingredient with proportion to its molar concentration
c) By assuming the temperature below 20°C to lower the rate of degradation
d) By increasing the activation energy to decrease the rate of degradation
View Answer
Explanation: A drug’s shelf life can be predicted using the Arrhenius equation by assuming the stability of the product with the help of known activation energy. The Arrhenius equation can be given by ln k = ln A – \(\frac{E_a}{RT}\), where Ea denotes activation energy.
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