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Magnesium Orotate (Dihydrate)
Product Name Magnesium Orotate (Dihydrate)
Other name

Magnesium salt of Uracil-6-Carboxylic acid

CAS No.

34717-03-8

Molecular Formula C10 H6 MgN4 O8.2H2O
Molecular Weight 370.6
 
Analytical Specifications for Magnesium Orotate (Dihydrate)

Tests

 

Limits (As per DAC)

Appearance

:

A white to almost white crystalline powder.

Solubility

:

Hardly soluble in water. Practically insoluble in 96 % ethanol and ether.

Identification
IR
Magnesium


:
:


Shall pass the IR Spectrum.
Shall pass the test.

Acidity or Alkalinity test:
1.5g of substance suspended in 30ml of water, stir for 5 minutes and filtered.

:

10 ml of the filtrate solution should not consume more than 0.25 ml of 0.01 M HCl solution (or) 10 ml of filtrate solution should not consume more than 0.5 ml of 0.01 N NaOH solution.

Specific Absorbance

:

A1cm (1.0%) 298 - 318 at 285nm.

Amino acid test on 1g sample

:

Shall be absent.

Sulphate

:

Maximum 200 ppm.

Heavy Metals

:

Maximum 20 ppm.

Related substances. Hydantonitrile

:

Not more than 0.1%

Assay (by Complexometric titration)

:

98.0 % to 101.0 %

 
Additional Tests
Lead : Max. 5 ppm
Arsenic : Max. 3 ppm
pH : 5.0 to 7.0
Mineral Content : 6.3% - 6.5 %
Bulk density (Loose Kg/m3) : 400 to 500 Kg/m3
Particle Size # 40 mesh (US) (pass through) : Minimum 80.0 %
 
Microbial Limit Tests:
Total aerobic count :

Max. 1000 CFU/g

Total moulds and yeasts

:

Max. 100 CFU/g

E.Coli : Absent
Salmonella : Absent
 

1. Method of testing as per DAC as applicable.

2. In-house specs – Method of testing available on request.

3. MSDS - Available on request.

 
Other:
Shelf life : 3 years from date of manufacturing.
Storage condition : Preserve in a sealed container at temperature between 20-250C.
Manufacturing Condition : WHO cGMP approved.
Quality Certification : ISO, USFDA, EDQM, cGMP, EU-Compliance, HACCP, KOSHER – StarK PAREVE Status, HALAL & ICH-Q7A.
Packaging Units : Products can be supplied in packaging ranging from 20 kgs – 50 kgs
Packing : Packing Material options include HDPE Bags Plastic Drums,
Fiber Drums, Fiber Kegs, High Resistance Paper Sacks and High Density Carton with inner HDPE liner sealed air tight.
Dated : 25th September 2006