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Magnesium Gluconate USP FCC
Product Name Magnesium Gluconate USP FCC
Other name D - Gluconic acid Magnesium salt
CAS No.

3632-91-5
Molecular Formula C12 H22 MgO14
Molecular Weight 414.6
 
Analytical Specifications for Magnesium Gluconate USP FCC

Tests

 

Requirements

Description

:

A white to off white powder

Solubility

:

Soluble in water, freely soluble in boiling water

Identification    

Magnesium
TLC

:
:

Shall pass the test
Shall pass the test

pH (1 in 20)

:

Between 6.0 and 7.8

Water content

:

Between 3.0 % and 12.0%

Chloride

:

Max 0.05%

Sulfate

:

Max.0.05%

Heavy metals

:

Max 0.002%

Reducing substances

:

Max 1.0%

Organic volatile impurities

:

Shall meet the requirements

Residual solvents

:

Shall meet the requirements

Assay as C12H22MgO14 (calculated on the anhydrous basis)

:

98.0% -102.0%

Lead

:

Max. 0.5 mg / kg (0.5 ppm)

 
Additional tests (In-house)
Mercury Max. 1 ppm
Magnesium content ( on as is basis) 5.04% - 5.80%
Clarity of 10% w/v solution at 250C Clear to nearly clear
Colour of 10% w/v solution at 250C Colourless to nearly colourless
Particle Size Distribution passing thru' U.S 80 # More than 90 % w/w
Bulk density (Loose) 250-650 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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