Magnesium Pidolate BP

Abstract:
Magnesium pidolate, the magnesium salt of pidolic acid (pyroglutamic acid). It occurs as a amorphous, white or almost white powder, hygroscopic.

 

Uses/Applications:
is a mineral supplement, which contains 8.664% magnesium w/w.

 

Identity:
Molecular Formula: C10H12N2O6Mg
Molecular Weight: 280.5 g/mol
CAS No.: 62003-27-4

 

General Specifications:

Test Specification
Characters It occurs as a amorphous, white or almost white powder, hygroscopic.
Identification

Test A

Test B

 

(a) Thin layer chromatography.

(b) Specified test. The solution gives  the reaction of magnesium

Solubility Very soluble in water, soluble in methanol, practically insoluble in methylene chloride.
Appearance of solution Solution is clear and not more intensely colored than reference solution.
pH Between 5.5 to 7.0
Specific optical rotation Between -23.3 to -26.5 (anhydrous substances)
Related substances

-Impurity B

-Unspecified impurities

-Total of other impurities

-Disregard limit

 

Not more than 1%

Not more than  0.10%

Not more than  0.5%

Not more than  0.05%

Impurity A Not more than  0.6%
Chlorides Not more than  500 ppm
Nitrates Not more than  200 ppm
Sulphates Not more than  0.1%
Arsenic Not more than  2 ppm
Iron Not more than  200 ppm
Heavy metals Not more than  20 ppm
Water Not more than  8.0%
Assay Not less than 8.49% and more than 8.84% of Mg(anhydrous substance)
Impurity A It occurs as a amorphous, white or almost white powder, hygroscopic.

 

Shelf life, Storage and Packing

It should be stored in a segregated area in a cool and ventilated place away from combustible materials. Keep in a tightly closed container, sealed until ready for use. It is packed in 25kg or 50kg HDPE bags or drums as required.

 

Other
GLP, cGMP (FDA) Approved, ISO 9001, ISO 14001, ISO 45001, ISO 17025, ISO 22000, FSSC 22000, FSSAI, Halal and Kosher certified.
We observe WHO Good manufacturing practice and Good laboratory practice.

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