medicines, to differentiate between similar ingredients. ‘Alpha’ is appropriate when naming a structural isomer. ‘Sulfur’ versus ‘sulphur’—‘sulfur’ is used in containing this word or its derivatives (e.g. sulfate, sulfonate). ‘S’ versus ‘z’—words that have alternative ‘s’ or ‘z’ spellings (e.g. hydrolysed, hydrolyzed) are spelt with an ‘s’, consistent with Australian spelling convention. 2.3 Abbreviations Abbreviations are commonly used as synonyms for some chemical substances with long names (e.g. cyclohexanedimethanol is sometimes referred to as CHDM). These abbreviations should not be used. The full chemical name should be used in preference to the abbreviation. Table 2.2 lists some examples of AANs and known abbreviations. Table 2.2 Abbreviations for Australian approved names for chemicals Acceptable name Abbreviation (not to be used) cyclohexanedimethanol CHDM diolamine DEA dimethylol dimethyl DMDM hydroxyethyl ethylenediamine triacetic acid HEDTA maleic anhydride MA olamine MEA monoisopropanolamine MIPA dl-pyrrolidonecarboxylic acid PCA propylene glycol PG polypropylene glycol PPG polyvinyl methyl anhydride PVM/MA polyvinylpyrrolidone PVP sulfoisophthalate SIP saturated methylene diphenyldiisocyanate SMDI trolamine TEA vinyl acetate VA vinyl pyrrolidone VP
carbonate magnesium chloride potassium fluoride sodium iodide lactate nitrate nitrite octanoate phosphate sulfate tartrate 2.5.7 acids and other chiral substances Many chiral substances, such as amino acids, can exist as a single optical isomer (enantiomer) or as a mixture of isomers. The reference quoted for the name will define the isomer or mixture. In the case of amino acids, which mainly exist naturally in the l-form, the ‘l-’ prefix has been omitted from the approved name, even if it is included in the name shown in the reference. The designators, ‘dl-’ and ‘d-’ should be included in the of amino acids that occur naturally in these forms, to distinguish them from the ‘l’ form. This is consistent with INN naming policy. Inclusion of ‘d-’ and ‘dl-’ in the name improves the amount of information provided by the name and reduces ambiguity. The designators ‘R’, ‘RS’ and ‘S’ should not be used for chiral molecules, unless used in the reference or required to distinguish between different chiral molecules. 2.5.8 Metals For metals, the common name should be used; for example, ‘copper’ and ‘iron’, rather than ‘cuprous’ or ‘cupric’, and ‘ferrous’ or ‘ferric’. Common names are more readily understood by consumers. Where a single oxidation state occurs, that state should be included in the name (e.g. copper (I), copper (II), iron (II), iron (III)). Where mixed oxidation states occur, the names would merely be copper, iron, and so on (e.g. iron phosphate). 2.5.9 Colour names New names for ingredients used as colours should not include the Colour Index (CI) number. Separate names will be created for each colour and its lake (e.g. aluminium or calcium lake), as required (e.g. erythrosine and erythrosine aluminium lake).
nasal drops, emulsion nasal drops, powder for drops, solution nasal drops, suspension ointment oral liquid oral liquid, emulsion oral liquid, powder for oral liquid, solution oral liquid, suspension pad, impregnated paint concentrated paint, powder for paste pastille dermal pessary pessary, compressed pessary, modified release pessary, moulded pessary, shell pill powder powder, dusting powder, oral solution solution, powder for spray spray, nasal pressurised spray, solution spray, suspension lip suppository suppository, compressed suppository, moulded suppository, suspension suspension, powder for tablet, chewable tablet, dispersible tablet, effervescent tablet, enteric coated tablet, film coated tablet, gelatin coated tablet, modified release tablet, multilayer tablet, orally disintegrating tablet, soluble tablet, sugar coated tablet, uncoated tea Some approved terms to describe dosage forms are also known by other names (synonyms). Common synonyms are listed in Table 5.1. These synonyms are not to be used to describe the dosage form for registered or listed medicines.
Table A2.2 Key to the herbal substances plant preparations list Character Meaning Comments ~ Only use the term if it is applicable For example, ‘~dry/fresh’ means that the appropriate term of the ones given should be selected for use / The term may be formed any one of the given words For example, ‘juice ~dry/~fresh’ indicates that ‘juice dry’ and ‘juice fresh’ are both approved codes * Caution: contact the TGA if intending to claim standardisation ‘stand.’ may be omitted from the label if no claim is made # Solvent details are not required where the ingredient is an excipient ^ Only use where label space is limiting Table A2.3 Herbal substances plant preparations list Plant preparation Preparation type If final extraction ratio and solvents# required If equivalent dry/fresh weight required If component required Abbreviation for label Balsam may be included in the term for plant part; select the preparation, e.g. ‘fresh’, ‘extract ...’ Decoction decoc. (1:? in 100% W) EQUIV. AHN + part + ~dry/~fresh Required if claim: EQUIV. component ~AAN/~HCN decoction decoc.^ Decoction concentrate decoc. conc. (?:1 in 100% W) AHN + part + ~dry/~fresh Required if label claim: EQUIV. component ~AAN/~HCN decoction decoc.^
Extract: also refer oil, fat, wax, resin, oleoresin and balsam. If an extract of a fat, wax resin, oleoresin or balsam, ensure this term is part of the plant part, and use ‘extract etc.’ as the plant preparation Extract dry ext. dry (1:? in solvents) EQUIV. AHN + part + ~dry/~fresh Required if label claim: EQUIV. component ~AAN/~HCN extract Extract dry concentrate ext. dry conc. (?:1 in solvents) EQUIV. AHN + part + ~dry/~fresh Required if label claim: EQUIV. component ~AAN/~HCN extract Extract dry concentrate standardised* ext. dry conc. (?:1 in solvents) EQUIV. AHN + part + ~dry/~fresh EQUIV. stand. comp. ~AAN/~HCN extract standardised* extract stand.*^ ext. stand.*^ Extract dry standardised* ext. dry stand. (1:? in solvents) EQUIV. AHN + part + ~dry/~fresh EQUIV. stand. comp. ~AAN/~HCN extract standardised* extract stand.*^ ext. Extract liquid ext. liq. (1:? in solvents) EQUIV. AHN + part + ~dry/~fresh Required if label claim: EQUIV. component ~AAN/~HCN extract Extract liquid concentrate ext. liq. conc. (?:1 in solvents) EQUIV. AHN + part + ~dry/~fresh Required if label claim: EQUIV. component ~AAN/~HCN extract
Extract liquid concentrate standardised* ext. liq. conc. stand. (?:1 in solvents) EQUIV. AHN + part + ~dry/~fresh EQUIV. stand. comp. ~AAN/~HCN extract standardised* extract stand.*^ ext. stand.*^ Extract liquid standardised* ext. liq. stand. (1:? in solvents) EQUIV. AHN + part + ~dry/~fresh EQUIV. stand. comp. ~AAN/~HCN extract standardised* extract stand.*^ ext. Extract oil infused: refer oil infused Extract soft ext. soft (1:? in solvents) EQUIV. AHN + part + ~dry/~fresh Required if label claim: EQUIV. component ~AAN/~HCN extract Extract soft concentrate ext. soft conc. (?:1 in 100% W) EQUIV. AHN + part + ~dry/~fresh Required if label claim: EQUIV. component ~AAN/~HCN extract Extract soft concentrate standardised* ext. soft conc. stand. (?:1 in 100% W) EQUIV. AHN + part + ~dry/~fresh EQUIV. stand. comp. ~AAN/~HCN extract standardised* extract ext. stand.*^ Extract soft standardised* ext. soft stand. (1:? in solvents) EQUIV. AHN + part + ~dry/~fresh EQUIV. stand. comp. ~AAN/~HCN extract standardised* extract stand.*^ ext. stand.*^ Fat: if an extract of a fat, ensure ‘fat’ is part of the plant part and use ‘extract etc.’ as the plant preparation fat – Required if claim: EQUIV. AHN + part + ~dry/~fresh Required if label claim: EQUIV. component ~AAN/~HCN fat
Juice concentrate standardised* juice conc. stand. – EQUIV. AHN + part + juice ~dry/~fresh EQUIV. stand. comp. ~AAN/~HCN juice concentrate standardised* concentrate stand.*^ juice conc. stand.*^ Juice dry juice dry – Required if claim: EQUIV. AHN + part + juice fresh Required if label claim: EQUIV. component ~AAN/~HCN juice dry juice powder dry standardised* juice dry stand. – Required if label claim: EQUIV. AHN + part + juice fresh stand. comp. ~AAN/~HCN dry standardised* juice powder standardised* juice dry stand.*^ juice powder stand.*^ Juice fresh juice fresh – Required if claim: EQUIV. AHN + part + juice dry Required if label claim: EQUIV. component ~AAN/~HCN juice fresh juice Juice fresh standardised* juice fresh stand. – Required if label claim: EQUIV. AHN + part + juice dry EQUIV. stand. comp. ~AAN/~HCN juice fresh standardised* juice standardised* juice fresh stand.*^ juice stand.*^ powder juice dry – Required if label claim: EQUIV. AHN + part + juice fresh Required if label claim: EQUIV. component ~AAN/~HCN juice dry juice powder
Juice powder standardised* dry stand. – Required if label claim: EQUIV. AHN + part + juice fresh EQUIV. stand. comp. ~AAN/~HCN dry standardised* juice powder standardised* juice dry stand.*^ juice powder stand.*^ Latex: is part of the plant part; select the preparation, e.g. ‘fresh’, ‘extract...’ Oil essential oil ess. – Required if label claim: EQUIV. AHN + part + ~dry/~fresh Required if claim: EQUIV. component ~AAN/~HCN oil essential oil ess.^ oil^ Oil oil – Required if label claim: EQUIV. AHN + part + ~dry/~fresh Required if label claim: EQUIV. component ~AAN/~HCN oil fixed oil^ Oil infused CAUTION: quantify the active ingredient oil (do not include the quantity of solvent oil used) oil inf. CAUTION the solvent oil(s) are also in the product, name and quantify these excipient(s) separately – Required if label claim: EQUIV. AHN + part + ~dry/~fresh Required if claim: EQUIV. component ~AAN/~HCN oil infused oil inf.^ oil Oleoresin: if an extract of an oleoresin, ensure ‘oleoresin’ is part of the plant part, and use ‘extract etc.’ as the plant preparation
Potency: refer homoeopathic potency Powder powder – Required if label claim: EQUIV. AHN + part + fresh Required if label claim: EQUIV. component ~AAN/~HCN powder Powder standardised* powder stand. – Required if label claim: EQUIV. AHN + part + fresh EQUIV. stand. comp. ~AAN/~HCN powder standardised* powder stand.*^ Resin: is part of the plant part; select the preparation, e.g. ‘fresh’, ‘extract…’ Sap and ‘sap balsam’: are part of the plant parts; select the preparation, e.g. ‘fresh’, ‘extract ...’ Spagyric spagyric (1:?): prep 1 (?:? in solvents) & prep 2 ... etc @ AHN + part + ~dry/~fresh Required if label claim: EQUIV. component ~AAN/~HCN spagyric Spagyric concentrate spagyric conc. (?:1): prep 1 (?:? in solvents) & prep 2 ... etc EQUIV. AHN + part + ~dry/~fresh Required if label claim: EQUIV. component ~AAN/~HCN spagyric Spagyric concentrate standardised* spagyric conc. stand. (?:1): prep 1 (?:? in solvents) & prep 2 ... etc EQUIV. AHN + part + ~dry/~fresh stand. comp. ~AAN/~HCN spagyric standardised* spagyric
Spagyric standardised* spagyric stand. (1:?): prep 1 (?:? in solvents) & prep 2 ... etc EQUIV. AHN + part + ~dry/~fresh EQUIV. stand. comp. ~AAN/~HCN spagyric standardised* spagyric stand.*^ Tincture tinct. (1:? in solvents) EQUIV. AHN + part + ~dry/~fresh Required if label claim: EQUIV. component ~AAN/~HCN tincture Tincture standardised* tinct. stand. (1:? in solvents) EQUIV. AHN + part + ~dry/~fresh EQUIV. stand. comp. ~AAN/~HCN tincture standardised* tinct. stand.*^ Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia Email: info@tga.gov.au Phone: 1800 020 653 Fax: 02 6232 8605 R12/999881