DPL-US Magnesium Carbonate

DPL-US Magnesium Carbonate is a white powder used in pharmaceutical preparations. It is ideal as an absorbent/binder, bulking agent, and opacifier. Used primarily in food and technical applications

Ingredient Name: Magnesium Carbonate

Functions: Binder, Bulking Agent, Dietary Supplement, Mineral Source, Mineral Source, Opacifier, Supplement

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Identification & Functionality

Ingredient Name
Mineral Type
Food Ingredients Functions
Ingredients
Magnesium Carbonate
Food Additive Number
E 504(i), INS 504(i)
Chemical Formula

4MgCO₃*Mg(OH)₂*5H₂O

Features & Benefits

Food Ingredients Features

Applications & Uses

Food & Nutrition Applications

Properties

Physical Form
Appearance
White powder
Typical Properties
ValueUnitsTest Method / Conditions
Acid-Insoluble Substancesmax. 0.05%
Arsenic (As)max. 0.0004%
Assay (MgO)40.0 - 43.5%
Bulk Density (Loose)approx. 500.0g/l
Calcium (Ca)max. 0.45%
Calcium Oxide (CaO)max. 0.6%
Escherichia coliAbsent
IdentificationConforms
Iron (Fe)max. 0.02%
Lead (Pb)max. 0.0002%
Molecular Weightapprox. 485g/mol
Nickel (Ni)max. 100ppmICH-Q3D
Soluble Substancesmax. 1.0%
Total Aerobic Microbial Countmax. 2000CFU/g
Total Yeast and Mold Countmax. 200CFU/g

Regulatory & Compliance

Certifications & Compliance
Residual Solvents Presence Confirmation

Regarding the Residual Solvents we state herewith, that the controlled production, handling and storage of this material precludes the presence of the organic solvents as specified in Ph.Eur. (ICH 283/95) and USP <467>.

Heavy Metal Parameters

Heavy metal parameters of this specification have been set in accordance to ICH Q3D guideline for elemental impurities on basis of a product related risk assessment. The risk assessment has been conducted considering option 1 (max. daily intake of 10g/d) for an oral application. Unless otherwise indicated or specified, the elements of class 1-3 (classification acc. ICH Q3D) are not likely to be present above the ICH Q3D option 1 limit in accordance to our assessment. Further elements are not intentionally added. The specification comprises elemental impurities based on the corresponding monograph. These elements are furthermore considered in the specification to comply with the monograph.