10. a. Solvolysis-In solvolysis the active drug undergo decomposition following reaction with the solvent present.

b. Oxidation-In pharmaceutical dosage forms, oxidation is usually mediated through reaction with atmospheric
oxygen under ambient conditions, a process commonly referred to as autoxidation.
c. Dehydration-The preferred route of degradation for prostaglandin E2 and tetracycline is the elimination of a water
molecule from their structures.
d. Optical isomerization-A change in the optical activity of a drug may result as a change in its biological activity.
e.Hydrolysis- It is probably the most commonly encountered mode of drug degradation because of the prevalence of
such groups in medicinal agents and the ubiquitous nature of water.

11.a.. Exclusion of oxygen ,Use of amber or coloured glass containers , Use of chelating agents , Use of
antioxidants

b. Use of surfactant-based systems such as micelles can reduce the hydrolysis of hydrophobic drugs. Alternatively,
preparing a suspension reduces the amount of drug in solution and hence may increase stability. A lyophilized
product will remove water and significantly reduce the rate of hydrolysis.

12. Five types of stability concern pharmacists:

1. Chemical: Each active ingredient retains its chemical integrity and labeled potency within the specified limits.
2. Physical: The original physical properties, including appearance, palatability, uniformity, dissolution, and
suspendability, are retained.
3. Microbiologic: Sterility or resistance to microbial growth is retained according to the specified requirements.
Antimicrobial agents retain effectiveness within specified limits.
4. Therapeutic: The therapeutic effect remains unchanged.
5. Toxicologic: No significant increase in toxicity occurs

13.

14. Following FDA product approval and initial marketing, pharmaceutical manufacturers retain
production samples of drug/drug product for 5 years or longer and continue studies for signs of
degradation under various conditions of storage. Pharmacy practitioners should also observe signs of
product instability (e.g., color change, distorted capsules, softened tablets, etc.) and report such
findings.