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Zinc Gluconate USP / FCC
Product Name Zinc Gluconate USP / FCC
Other name Zinc D- Gluconate
CAS No. 4468-02-4
Molecular Formula C12 H22 ZnO14
Molecular Weight 455.68
 
Analytical Specifications for Zinc Gluconate USP / FCC

Tests

 

Requirements

Description

:

A white or practically white powder

Solubility

:

Soluble in water, freely soluble in boiling water

Identification    

Zinc
TLC

 :
:

Shall pass the test
Shall pass the test

pH (1 in 100)

:

Between 5.5 and 7.5

Water

:

Not more than 11.6%

Chloride

:

Max.0.05%

Sulfate

:

Max.0.05%

Arsenic

:

Max.3 ppm

Reducing substances

 

Max.1.0%

Cadmium

:

Max. 2 mg / kg (2 ppm)

Lead

:

Max. 1 mg / kg (1 ppm)

Organic volatile impurities

 :

Shall meet the requirements

Residual solvents

:

Shall meet the requirements

Assay as C12 H22ZnO14
(Calculated on the anhydrous basis)

:

97.0 % - 102.0%

 
Additional tests (In-house)
Clarity of 10% w/v solution at 250C Clear to nearly clear
Colour of 10% w/v solution at 250C Colourless to nearly colourless
Zinc content (on as is basis) 12.25%-14.64 %
Mercury Max. 1 ppm
Particle Size Distribution
Passing thru' U.S 80 #
More than 90 % w/w
Bulk density (Loose) 350 - 700 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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