Naming conventions apply to all ingredient names. How to name your ingredient will depend on which category of substance type it falls under.
Naming convention for all approved ingredient names
The following information applies to all ingredient names.
Punctuation
Avoid punctuation marks as they reduce searchability in the Ingredients Table. Chemical names can use punctuation, for example 1,3-butylene glycol and cis-3-hexen-1-ol.
Inversion of names
Don’t invert ingredient names. For example, the correct approved name is 'bovine insulin' not 'insulin - bovine'.
Synonyms
Use the approved name on your therapeutic good. You cannot use a synonym. Synonyms in the Ingredients Table are for cross-referencing.
Rules for spelling chemical names
Alfa vs alpha
Use of 'alpha' or 'alfa' in an ingredient name depends on the context:
- use 'alfa' for active ingredients in biological medicines
,to differentiate between similar ingredients - use 'alpha' to name a structural isomer.
Sulfur & sulphur
Use sulfur (rather than sulphur), including its derivatives, for example sulfate, sulfonate.
Alternative 's' or 'z' spellings
Spell words that have alternative 's' or 'z' spellings with an 's'. For example, spell hydrolyzed as hydrolysed.
International Non-proprietary Name (INN) spelling conventions
International non-proprietary name (INN) spelling conventions apply:
- use 'i' instead of 'y', for example sibutramine mesilate instead of sibutramine mesylate
- use 't' instead of 'th', for example butizide instead of buthiazide
- use 'e' instead of 'ae' or 'oe', for example estrogen instead of oestrogen
- use 'f' instead of 'ph', for example sulfacetamide instead of sulphacetamide
- avoiding using 'h' and 'k', for example colecalciferol instead of cholecalciferol.
Substance type impacts ingredient naming conventions
The ingredient’s source, or substance type impacts how an ingredient is named.
Different substance types have additional, specific, naming conventions.
You must know the substance type of your ingredient to name it correctly.
Ingredient and tissue substance types
Chemical substances
- Include antibiotics derived from a natural source or synthetically created in a laboratory.
See naming convention for chemical substances
Biological substances
- Biological substances derived from human, animal or microbiological sources.
- The approved name may include the name of the organism and the part of the organism and the preparation.
- Does not include plants, fungi, yeasts or antibiotics.
See naming convention for biological substances
Cell and tissue substances
- Cell and tissue substances are of biological origin including blood, blood components, tissue and cellular products, and tissue and cell-based derivatives.
- Does not include vaccines, peptides, monoclonal antibodies and antibiotics.
Also see naming convention for biological substances
Herbal substances
- Include plants, fungi, algae and yeasts.
- Herbal substances have different preparation types than a chemical ingredient.
- For example, plant part (for example, leaf) and preparation (for example, extract).
- There are two main types of herbal substances, defined entity and plant species.
Herbal substance (defined entity)
- Herbal substance defined by a pharmacopoeial monograph.
- For example, 'St John's Wort herb dry'.
- The identity and quality of the substance must match the monograph that is the source of the substance name.
Herbal substance (plant species)
- A plant species expressed as its Latin binomial name.
- For example, Hypericum perforatum.
- Must use a complete approved herbal name on applications and labels.
- A complete approved herbal name includes the plant part and the plant preparation (including solvents and extract ratio if applicable).
See:
Complete approved herbal names for creating a complete name.
Herbal ingredients for more information about herbal ingredients in general.