New ingredient names available for metal amino acid chelates

6 March 2015

Background

Naming and characterisation ambiguities associated with metal amino acid chelates was originally discussed at the Interim Joint Expert Advisory Committee on Complementary Medicines (IJEACCM) (20-21 July 2006), as part of the Permitted Ingredients List (PIL) Project. A list of ingredients for review was identified as part of this project.

The TGA has since engaged in extensive pre consultation with the OCM/Industry Consultation Group (OICG) regarding the chelate ingredient names. Identification of the ingredients most relevant to the Australian market was provided by industry via the Complementary Healthcare Council of Australia and Australian Self-Medication Industry.

New ingredient names available for metal amino acid chelates

20 specific Australian Approved Names (AANs) for metal amino acid chelates have been made available for use in the Electronic Listing Facility (ELF).

The new names have been added to allow sponsors to identify ingredients more accurately. The ingredient names in ELF include the approved name and molecular formula for each ingredient. The associated ingredient rules are consistent with the chelate names in Part 3 of Schedule 4 to the Therapeutic Goods Regulations 1990. That is, the relevant mineral is a mandatory component and the purpose for use for all metal amino acid chelates is restricted to mineral supplementation.

In addition, the TGA would like to clarify that the availability of new specific names for metal amino acid chelates for use in listing a medicine on the Australian Register of Therapeutic Goods is not an approval of new ingredients for use in listed medicines. The new ingredient names are based on metal and amino acid components that are themselves already eligible and available for use in listed medicines. Generation of compositional guidelines and listing notices for gazettal of new ingredients is not required.

The reference for all the new metal amino acid chelate names is 'TGA 2011'. In the absence of an easily accessible document for the reference, the molecular formula and structure, and the Chemical Abstracts Service (CAS) Registry number (where it exists), are the best way for sponsors to check whether a substance matches a particular AAN (see table below).

The limits for the metal content are also provided in the table below. In the absence of a standard (Therapeutic Goods Order or a monograph), the TGA considers these assay limits acceptable for each substance.

List of Australian Approved Names for metal amino acid chelates included in ELF
Approved Name Molecular formula Chemical structure CAS Registry Number Acceptable limits
of metal content (%)
Calcium aspartate C4H5NO4Ca Chemical structure of calcium aspartate 21059-46-1 22.2-24.6
Calcium diaspartate (C4H6NO4)2Ca Chemical structure of calcium diaspartate 39162-75-9 12.5-13.8
Calcium aspartate hydrochloride dihydrate (C4H5NO4)Ca•HCl•2H2O Chemical structure of calcium aspartate hydrochloride dihydrate 92533-40-9 15.6-17.3
Calcium glycinate (C2H4NO2)2Ca Chemical structure of calcium glycinate 35947-07-0 20.2-22.4
Calcium glycinate dihydrate (C2H4NO2)2Ca•2H2O Chemical structure of calcium glycinate dihydrate 33242-26-1 17.0-18.8
Calcium lysinate (C6H13N2O2)2Ca Chemical structure of calcium lysinate 6150-68-1 11.5-12.7
Calcium methioninate (C5H10NO2S)2Ca Chemical structure of calcium methioninate Nil 11.3-12.5
Iron (II) glycinate
Synonym = Ferrous bisglycinate
(C2H4NO2)2Fe Chemical structure of iron (II) glycinate 20150-34-9 26.0-28.8
Iron (II) bisglycine sulfate trihydrate

(C2H5NO2)2•FeSO4•3H2O

Chemical structure of iron (II) bisglycine sulfate trihydrate Nil 14.9-16.5
Iron (III) glycinate
Synonym = ferric trisglycinate
(C2H4NO2)3Fe Chemical structure of Iron (III) glycinate 34369-82-9 19.1-21.1
Magnesium glycinate (C2H4NO2)2Mg Chemical structure of magnesium glycinate 14783-68-7 13.4-14.8
Magnesium glycinate dihydrate (C2H4NO2)2Mg•2H2O Chemical structure of magnesium glycinate dihydrate Nil 11.1-12.2
Magnesium lysinate (C6H13N2O2)2Mg Chemical structure of magnesium lysinate 151753-50-3 7.3-8.1
Magnesium methioninate (C5H10NO2S)2Mg Chemical structure of magnesium methioninate 106207-65-2 7.2-8.0
Manganese (II) diaspartate (C4H6NO4)2Mn Chemical structure of manganese (II) diaspartate Nil 16.4-18.1
Manganese (II) glycinate (C2H4NO2)2Mn Chemical structure of manganese (II) glycinate 14281-77-7 25.7-28.4
Zinc diaspartate (C4H6NO4)2Zn Chemical structure of zinc diaspartate 36393-20-1 18.9-20.8
Zinc glycinate (C2H4NO2)2Zn Chemical structure of zinc glycinate 14281-83-5 29.1-32.2
Zinc lysinate (C6H13N2O2)2Zn Chemical structure of zinc lysinate 23333-98-4 17.5-19.3
Zinc methionine sulfate C5H11NO2S•ZnSO4 Chemical structure of zinc methionine sulfate 56329-42-1 20.0-22.1