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

Zinc salt of Uracil-6-Carboxylic acid

CAS No.

5970-45-6

Molecular Formula C10 H6 N4 O3 Zn 2H2O
Molecular Weight 411.6
 
Analytical Specifications for Zinc Orotate (Dihydrate)

Tests

 

Limits (As per DAC)

Characters

:

A white to almost white crystalline powder.

Solubility

:

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

Identification    

IR
Zinc

:
:

Shall pass the test
Shall pass the test

UV Absorption Maxima

:

A1cm (1.0%) 269 to 285nm at 285nm

pH (1.0% suspension in water)

:

Between 3.0 to 5.0

Sulphate

:

Not more than 200 ppm

Chloride

:

Not more than 100 ppm

Amino acids test on 1g sample

:

Shall be absent.

Related substances
Hydantonitrile

:


Not more than 0.1%

Assay by complexometric titration (dried basis)

:

Between 98.0 % – 101.0 %

 
Additional Tests
Lead : Max. 5 ppm
Arsenic : Max. 3 ppm

Mineral Content as Zinc

: 15.56 % - 16.04 %
Bulk density (Loose Kg/m3) : 400 to 600 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