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level: Level 2 of Thermodynamics

Questions and Answers List

Question	Answer
The capability of chemical drug and its particular formulation in a specific container/closure system to remain within its physical, chemical, microbiological, therapeutic and toxicological specifications. Pharmaceutical product should meet their expected quality, purity, and strength for specific period of time under certain conditions (storage conditions).	Drug Stability
Microscopic Physical States with Different Degree of Orders:	Amorphous state Crystalline state Hydrated state Solvated state
desirable physical state of drug product because it is easily dissolved; if it is easily dissolved, then it is easily absorbed by the body.	Amorphous state
minimal quantity	Crystalline state
property of drug product if it contains water or not.	Hydrated state
ability of drug product to dissolve in a solvent.	Solvated state
Physical Change	- Appearance - Melting Point - Clarity and Color of Solution - Moisture - Crystal Modifications (Polymorphism) - Particle Size
It is the ability of solid substances to appear in different forms	• Polymorphism