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Calcium Gluconate USP FCC (Anhydrous / Monohydrate)
Product Name Calcium Gluconate USP FCC (Anhydrous / Monohydrate)
Other name D-Gluconic acid Calcium salt
CAS No. 299-28-5 ( Anhydrous) / 18016-24-5 (Monohydrate)
Molecular Formula C12 H22 CaO14 (AH) / C12 H22 CaO14 H2O (MH)
Molecular Weight 430.37 (AH) / 448.39 (MH)
 
Analytical Specifications for Calcium Gluconate USP FCC (Anhydrous / Monohydrate)
Tests   Specifications:
Characters : A white crystalline or granular powder.
Solubility : Sparingly (slowly) soluble in water, freely soluble in boiling water
Identification    

TLC
Calcium

 :
:

Shall pass the test.
Shall pass the test.

Loss on drying (w/w)

 : Max. 3.0 % (Anhydrous)
Max. 2. 0 % (Monohydrate)

Chloride

 :

Max.0.07%
Sulfate : Max.0.05%
Arsenic : Max.3 ppm
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 C12 H22 CaO14 (on dried basis)
 : 98 .0 % -102.0% (Anhydrous)
Assay as C12 H22 CaO14H2O : 98.5 % -102.0% (Monohydrate)
Lead : Max.0.2 mg/ kg (0.2 ppm) in house
 
Additional tests (In-house)
Calcium content (on as is basis) 8.85 % - 9.50 % (Anhydrous)
8.80% - 9.12 % (Monohydrate)
Mercury Max. 1 ppm
Iron Max. 20 ppm
pH (5% solution) App.7.0
Particle Size Distribution
Passing thru' U.S 16 #
More than 70 % w/w
Bulk density (Loose) 250-600 kg/ m3
 
Microbial Limit Tests (in- house)
Total viable aerobic count Max.500 cfu /g
Total fungus Max.50 cfu / g
Enterobacteriaceae Absent in 1 g
E.Coli Absent in 10 g
Salmonella
 Absent in 50 g
Staphylococcus aureus
 Absent in 10 g
Pseudomonas aeruginosa 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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