- Chemical: Each API (active ingredient retains its chemical integrity and labeled potency within the specified limit.
- Physical: the physical stability properties includes appearance, palatability, uniformity, dissolution and suspend ability are retained.
- Microbiological: Sterility or resistance to microbial growth is retained according to specified to specified requirement.
- Therapeutic: therapeutic activity remains unchanged.
- Toxicologic: No significant increase in toxicity occurs.
Like this:
Like Loading...
