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Stability & Quality

Stability Testing

ICH compliant and cGMP stability studies are an established procedure for Avanti’s chemists.

Equipment

  • (2) -80°C freezers
  • (2) -20°C freezers
  • (1) 4°C refrigerated chamber
  • (1) 25°C/60% relative humidity chamber
  • (1) 30°C/65% relative humidity chamber
  • (1) 40°C/75% relative humidity chamber

Quality Control

The two driving forces behind Avanti’s reputation for quality are:

  • A determination that only the best is good enough.
  • Quality is engineered into the production process at its inception.

Our production chemists are proud to have Avanti’s world famous Analytical Laboratory backing them up and nothing gets past them! Our development reports are routinely used by our customers, and our Regulatory Department is eager to assist in this.

FDA Inspections

Avanti has been inspected by FDA on numerous occasions since 1990. The most recent inspection was April 2015.