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Schedule PURITY CRITERIA FOR MAGNESIUM L-THREONATE MONOHYDRATE

Original text. Later amendments are not shown.

Synonym Magnesium L-threonate
Definition
Chemical nameMagnesium (2R,3S)-2,3,4-trihydroxybutanoate monohydrate
CAS number500304-76-7 f1
Chemical formulaC 8H 16MgO 11
Molecular weight312.51 Da
Colour (solid)White
Assay

Magnesium: 7.2% to 8.3%

L-threonate: 82% to 91%

Description A 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 USP f2 (1% in H₂O) 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 ppm
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. This is available at https://www.cas.org/cas-data/cas-registry

f2

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). USP is a nonprofit scientific organisation that develops and disseminates public compendial quality standards for medicines and other articles. The USP is available at https://www.usp.org