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Potassium Gluconate USP FCC (Anhydrous)
Product Name Potassium Gluconate USP FCC (Anhydrous)
Other name D- Gluconic acid, mono potassium salt
CAS No.

299-27-4

Molecular Formula C6 H11 KO7
Molecular Weight 234.25
 
Analytical Specifications for Potassium Gluconate USP FCC (Anhydrous)

Tests

 

Requirements

Description

:

White to off white crystalline or granular powder

Solubility

:

Freely soluble in water, Practically insoluble in dehydrated alcohol, in ether.

Identification

:

Shall pass the test

Loss on drying

:

Max. 3.0 % w/w

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 C6H11KO7 (Calculated on the dried basis)

:

98.0% - 103.0%

Lead

:

Max. 2 mg / kg ( 2 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 Colourless to nearly colourless
Potassium content (on as is basis) 15.86 % - 17.19%
pH (5% solution) App.7.0
Mercury Max. 1 ppm

Particle Size Distribution Passing thru’ U.S 16 #


More than 80 % w/w
Bulk density (Loose) 600– 950 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 gm
 

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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