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Glossary Item

Human product excipients list : approved biological excipients

Effective 29 September 2016 to 24 December 2016

Preferred Term: excipient

Other Terms:

Definition:

Biological excipients are highly processed substances that are components of commercially packaged human therapeutic products, laboratory materials or food products. The following substance groups are considered excipients for human therapeutic products, laboratory materials or products intended for human consumption only and are excipients only when ready for retail sale without any further processing:

  1. Alcohol

  2. Purified amino acids (excluding those derived from neural material)

  3. Essences

  4. Esters

  5. Fish oil (other than salmon oil)

  6. Gelatine

  7. Glucosamine, chondroitin and chitosan of aquatic animal origin (unless derived from fish of the family Salmonidae)

  8. Homeopathics

  9. Pectins

  10. Plant acids

  11. Plant extracts

  12. Plant flours

  13. Plant gums

  14. Plant juices

  15. Plant oils

  16. Plant waxes

  17. Polysorbates

  18. Purified antibiotics/antimycotics manufactured without the use of materials of animal origin

  19. Purified avermectin compounds manufactured without the use of materials of animal origin

  20. Refined chemicals derived from wool grease, including cholesterol, cholecalciferol vitamin D3, lanolin or lanolin alcohols

  21. Resins

  22. Starches

  23. Stearates

  24. Sugars (including lactose)

  25. Tinctures

  26. Vinegars

  27. Vitamins

  28. Water