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Name of the ingredient
Levomefolate glucosamine (AAN)
Definition of the ingredient
(6S)-5-methyltetrahydrofolic acid, Glucosamine salt
Molecular formula: C32H51N9O16
Molecular Weight: 817.8019 g/mol
CAS number: 1181972-37-1
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | Cream to light brown powder |
| Characteristics | ||
| Solubility | BP General Notices | Very soluble in water; soluble in dilute acid and dilute alkali; Practically insoluble in most organic solvents. |
| pH (1% w/v aqueous solution) | Ph Eur method 2.2.3 | 5.5 - 6.5 |
| Identification | ||
| IR spectroscopy | USP <197A> | Spectrum complies with authenticated reference material. |
| Specific optical rotation (dry, 10% w/v in water) | USP <781> | +53° to +59 |
| Assay | ||
| Levomefolate glucosamine equivalent to (6S)-5-methyltetrahydro folic acid | HPLC | 96.0 to 102.0% on anhydrous basisequivalent to 53.8 to 57.1% on anhydrous basis |
| Glucosamine | HPLC | 42.2 to 44.9% on anhydrous basis |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Incidental metals and non-metals | ||
| While ingredient manufacturers are encouraged to include limits for Incidental metals and non-metals, it is the product into which those substances are formulated that contains the ingredient, alone or in combination with other ingredients, must comply with the acceptance criteria set in the United States Pharmacopeia - National Formulary general chapter '<2232> Elemental Contaminants in Dietary Supplements'. When testing is performed at the raw material stage, calculation of the total daily exposure in the finished product should be performed. This calculation is based on the quantity of each ingredient present in the product, the maximum potential contamination given the proposed limits for each raw material and the daily dose of the product. | ||
| Other organic or inorganic impurities or toxins | ||
| Diastereomeric purity | HPLC | Not less than 99.0% w/w |
| Water | USP <921> | Not more than 8.0% w/w |
| Total impurities | HPLC | Not more than 2.5% w/w |
| 4-Aminobenzoylglutamic acid (ABGA) | HPLC | Not more than 0.3% w/w |
| 4α-Hydroxy-5-methyltetrahydrofolic acid (HOMeTHFA) | HPLC | Not more than 1.0% w/w |
| (6S)-Pyrazino-s-triazine derivative [(6S)-Mefox] | HPLC | Not more than 0.3% w/w |
| 5-Methyltetra-hydropteroic acid (MeTHPA) | HPLC | Not more than 0.3% w/w |
| Any other impurity | HPLC | Not more than 0.15% w/w |
| Microbiology | ||
| While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines - external site' mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order. | ||
Key to abbreviations
AAN = Australian Approved Name
BP = British Pharmacopoeia
CAS = Chemical Abstracts Service
HPLC = High Performance Liquid Chromatography
IR = Infrared Spectroscopy
USP = US Pharmacopoeia