Glossary Item
Human product excipients list : approved biological excipients
Effective 24 December 2016 to 2 July 2019Preferred Term: excipient
Other Terms:
- approved pharmaceutical excipients
- list of pharmaceutical excipients for human therapeutics
- approved biological excipients
- List of biological excipients for laboratory material
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:
Alcohols
Citric acid
Cultures of Saccharomyces cerevisiae (or a derivative of a pure culture of Saccharomyces cerevisiae)
Essential oils
Esters
Fish oil (other than salmon oil)
Gelatine
Glucosamine, chondroitin or chitosan of aquatic animal origin (except if derived from fish of the family Salmonidae or intended for veterinary therapeutic use in aquatic animals)
Highly processed biochemicals derived from wool grease (including cholesterol, cholecalciferol vitamin D3, lanolin and lanolin alcohols)
Homeopathic preparations
Lactic acid
Lactose
Natural flavourings
Pectins
Plant acids
Plant extracts (other than flours or powders)
Plant gums
Plant juices
Plant oils
Plant waxes
Purified amino acids (other than those derived from neural material)
Purified antibiotics or antimycotics manufactured without using materials of terrestrial animal or avian origin (except if intended for veterinary therapeutic use in aquatic animals)
Purified avermectin compounds manufactured without using materials of terrestrial animal or avian origin (except if intended for veterinary therapeutic use in aquatic animals)
Purified corticosteroid manufactured without using materials of terrestrial animal or avian origin
Purified milbemycin compounds manufactured without using materials of terrestrial animal or avian origin (except if intended for veterinary therapeutic use in aquatic animals)
Resins
Starches
Sugars
Tinctures
Vinegars
Vitamins or provitamins
Water
Xanthan gum