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Schedule PURITY CRITERIA FOR MAGNESIUM L-THREONATE MONOHYDRATE

Original text. Later amendments are not shown.

SynonymMagnesium L-threonate
Definition
Chemical nameMagnesium (2R,3S)-2,3,4-trihydroxybutanoate monohydrate
CAS number500304-76-7f1
Chemical formulaC8H16MgO11
Molecular weight312.51 Daf2
Colour (solid)White
Assay

Magnesium: 7.2 % to 8.3 %

L-threonate: 82 % to 91 %

DescriptionA water-soluble white powder which is manufactured via a chemical synthetic process
Identification
SolubilitySoluble in water at 1 % concentration at 25℃ and that is clear in solution at 1 % concentration
pH USPf3 (1 % in H 2O)5.8 to 7.0
Purity
Loss on dryingNot more than 5.0 % (105℃, 4 hours)
Oxalic acid/oxalateNot more than 0.5% (as oxalic acid)
ArsenicNot more than 1 ppmf4
LeadNot more than 0.5 ppm
CadmiumNot more than 0.2 ppm
MercuryNot more than 0.1 ppm

Annotations

Footnotes

f1

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry

f2

The dalton (‘Da’), or unified atomic mass unit, is a unit of mass defined as one twelfth of the mass of an unbound neutral atom of carbon-12 in its nuclear and electronic ground state and at rest.

f3

United States Pharmacopoeia (USP), published by the United States Pharmacopeial Convention in Rockville, Maryland, USA. General Chapter 791 pH of the USP was revised in 2014 by a Supplement to the USP, published on 1st December 2014 (ISBN number 1936424223). The USP is available at https://www.usp.org

f4

A part per million (‘ppm’) is defined as one part of a substance per one million parts of a total mixture or solution. It is equal to a milligram per kilogram (‘mg/kg’).