Chapter 17 MCQs

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. Which of the following situations is unlikely to lead to the physical instability of a drug formulation?

Use of a stable polymorph correct incorrect

Elevated storage temperature correct incorrect

Use of a metastable polymorph correct incorrect

Use of a hydrate correct incorrect

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. Which of the following chemical instabilities is the least likely to take place in a drug formulation?

Isomerization correct incorrect

Oxidation correct incorrect

Photo-degradation correct incorrect

Hydrolysis correct incorrect

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. Which of the following drug substances is unlikely to experience hydrolysis as a chemical instability?

Aspirin correct incorrect

Lidocaine correct incorrect

Benzylpenicillin correct incorrect

Ascorbic acid correct incorrect

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. Which of the following functionalities found in drug substances will NOT undergo auto-oxidation?

Phenol correct incorrect

Primary alcohol correct incorrect

Ester correct incorrect

Tertiary amine correct incorrect

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. Which of the following drugs is likely to be photo-sensitive?

Folic acid correct incorrect

Morphine correct incorrect

Aspirin correct incorrect

Lidocaine correct incorrect

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. Which of the following reaction rate equations relates to a first-order reaction?

-d[A]/dt = k correct incorrect

-d[A]/dt = k[A] correct incorrect

-d[A]/dt = k[A]² correct incorrect

-d[A]/dt = [A] correct incorrect

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. Which of the following substances is NOT used as an antioxidant?

EDTA correct incorrect

Ascorbic acid correct incorrect

Sodium metabisulphite correct incorrect

Adrenaline correct incorrect

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. The Arrhenius equation is used in stability studies to investigate the effect of temperature on drug instability. Which of the following terms is NOT involved in the Arrhenius equation?

Activation energy correct incorrect

Solubility correct incorrect

Universal gas constant correct incorrect

Absolute temperature correct incorrect

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. Stress testing (i.e. determination of potential degradation) of a drug substance does NOT involve which of the following?

The effect of temperature greater than 40°C correct incorrect

The effect of humidity greater than 75% correct incorrect

The effect of heating with M HCl and M NaOH correct incorrect

The presence and absence of oxygen correct incorrect

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. Which of the following is NOT a recommended ICH storage condition?

21°C and 45% relative humidity correct incorrect

21°C and 60% relative humidity correct incorrect

30°C and 65% relative humidity correct incorrect

30°C and 75% relative humidity correct incorrect