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Ferrous Gluconate USP (Dihydrate)
Product Name Ferrous Gluconate USP (Dihydrate)
Other name

D - Gluconic acid, iron (2+) salt (2:1) dihydrate.

CAS No.

299 - 29 - 6

Molecular Formula C12 H22 FeO14.2H2O
Molecular Weight 482.17 (dihydrate)
 
Analytical Specifications for Ferrous Gluconate USP (Dihydrate)

Test

 

Limits (As per USP 29)

Description

:

Yellowish gray or pale greenish yellow, fine powder.

Solubility

:

Soluble in water with slight heating.
Practically insoluble in alcohol.

Identification

:

Shall pass the test

Loss on Drying (1050C for 16 hours)

:

6.5 to 10.0%

Chloride

:

Max. 0.07%

Oxalic acid

:

Shall pass the test.

Sulphate

:

Max. 0.1%

Arsenic

:

Max.2 ppm

Ferric Iron

:

Max. 2.0%

Mercury

:

Max. 3 ppm

Reducing Sugars

:

Shall pass the test

Organic volatile impurities

:

Shall pass the test

Assay as C12H22FeO14 (Calculated on dried basis)

:

97.0% to 102.0%

 
Additional Tests (In-House)
Lead : Max. 5 ppm
pH : 4.0 - 5.5
Mineral Content : 11.8 % to 12.5 %
Bulk density (Loose Kg/m3) : 550 to 700 Kg/m3
Particle Size
# 40 (US) mesh (pass through)		 : Minimum 90.0 %
 
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 USP 29 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
 
   
 
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