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Compositional guideline: Levomefolate glucosamine

9 August 2016

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

Table 1. Ingredient specific requirements
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 basis equivalent to 53.8 to 57.1% on anhydrous basis
Glucosamine HPLC 42.2 to 44.9% on anhydrous basis
Table 2. Incidental constituents
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' 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