• 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.

 

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