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Manganese Gluconate (Anhydrous /Dihydrate) USP/FCC
Product Name Manganese Gluconate (Anhydrous /Dihydrate) USP/FCC
Other name Manganese - D- Gluconate
CAS No. 6485-39-8
Molecular Formula C12 H22 MnO14 (AH) / C12 H22 MnO14 2H2O (DH)
Molecular Weight 445.23 (AH) / 481.27 (DH)
 
Analytical Specifications for Manganese Gluconate (Anhydrous /Dihydrate) USP/FCC

Tests

 

Requirements

Description

:

White to off – white or slightly pink coloured granular powder

Solubility

:

Soluble in water, freely soluble in boiling water

Identification    

Manganese
TLC

:
:

Shall pass the test
Shall pass the test

Water content

:

Between 3 .0% and 9.0 % (Anhydrous)
Between 6.0 % and 9.0% (dihydrate)

Chloride

:

Max.0.05 %

Sulfate

:

Max.0.2% (in house - max 0.1%)

Lead

:

Max.2 mg / kg (2 ppm)

Heavy metals

:

Max.20 ppm

Reducing Substances

:

Max.1.0%

Organic volatile impurities

:

Shall meet the requirements

Residual solvents

:

Shall meet the requirements

Assay as C12 H22MnO14 ( on anhydrous basis)

:

98.0% -102.0%

Arsenic

:

Max. 3 mg / kg (3 ppm)

 
Additional tests (In-house)
Clarity of 5% w/v solution at 250C Clear to nearly clear
Colour of 5% w/v solution at 250C Nearly colourless to slightly pink colour
Manganese content (on as is basis) 10.98 % - 12.22% (AH form)
11.35 % - 12.22% (DH form)
pH (5% solution) App.6.5
Mercury Max. 1 ppm

Particle Size Distribution
Passing thru’ U.S 16 #

More than 80 % w/w
Bulk density (Loose) 500– 900 kg/ m3
 
Microbial Limit Tests:
Total viable aerobic count : Max.500 cfu /g
Total fungus : Max.50 cfu / g
Enterobacteriaceae : Absent in 1g
E.Coli : Absent in 10 g
Salmonella : Absent in 50 g
Pseudomonas aeruginosa : Absent in 10 g
Staphylococcus aureus : Absent in 10 g
 

1. Method of testing as per USP 29, FCC V 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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