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Calcium Gluconate J.P (Monohydrate)
Product Name Calcium Gluconate J.P (Monohydrate)
CAS No. 18016-24-5
Molecular Formula C12 H22 CaO14 H2O
Molecular Weight 448.4
 
Analytical Specifications for Calcium Gluconate J.P (Monohydrate)
Tests   Specifications
Characters : A white, crystalline or granules odourless and tasteless.
Solubility : Freely soluble in hot water, soluble in water, and practically insoluble in ethanol (95%) and in diethyl ether

Identification

 :

Shall pass the test.

Purity

  

 

a. Clarity of solution ( 1 g in 50 ml water by warming i.e at 600C)   Should be clear
b. Acid or alkali   Shall pass the test
c. Chloride   Not more than 0.071%
d. Sulphate   Not more than0.048%
e. Heavy metals   Not more than 20 ppm
f. Arsenic   Not more than 3.3 ppm
g. Sucrose and reducing sugars   No orange yellow to red precipitate is formed immediately

Loss on drying(1g, 800C, 2 hours)

 :

Not more than 1.0%
Assay as C12 H22 CaO14H2O
(on a dried substance)		 : 99.0% -104.0%
 
Additional tests (In-house)
Calcium content (on as is basis) 8.76%-9.30 %
pH (5% solution) App.7.0
Lead Max.0.2 ppm
Mercury Max. 1 ppm
Iron Max 20 ppm
Particle Size Distribution
Passing thru' U.S 16 #
More than 70 % w/w
Bulk density (Loose) 250-600 kg/ m3
 
Microbial Limit Tests
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 JP XIV.

2. 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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