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Calcium Lactobionate USP
Product Name Calcium Lactobionate USP
Other name Lactobionic acid, Calcium salt (2:1) dihydrate
CAS No.

110638 –68-1

Molecular Formula C24 H42 CaO242H2O
Molecular Weight 790.68
 
Analytical Specifications for Calcium Lactobionate USP
Tests   Specifications:
Description : White to off- white crystalline powder may be partially granular

Odour

 :

Odourless

Solubility

 : Soluble in water. Freely soluble in boiling water

Identification
a) Calcium
b) IR Spectrum
c) TLC



Shall pass the test
Shall pass the test
Shall pass the test
Clarity of 15% w/v solution in boiling water : Clear to nearly clear
Colour of 15% w/v solution in boiling water : Colourless to nearly colourless
pH of the solution (1 in 20) : Between 5.4 and 7.4
Specific rotation : Between + 22.00 and + 26.50
Halides
: Max. 400 ppm
Sulphate : Max. 500 ppm
Phosphate : Max. 200 ppm
Heavy Metals : Max. 20ppm
Iron : Max. 40 ppm
Arsenic : Max. 1 ppm
Alkali metals and magnesium : Max. 0.5%
Reducing substances : Max. 1.0%
Organic volatile impurities (Residual solvents)
a) Ethanol
b) Acetone
 

Max. 3000 ppm
Max. 500 ppm
Assay : 96.0% -102.0%
Calcium content : 4.87 % - 5.17%
Particle Size Distribution
Passing thru’ U.S 4#
:
More than 90 % w/w
Bulk density (Loose) : 300-600 kg/ m3
 
Microbial Limit Tests:
Total viable aerobic count : Max. 1000 CFU/g
Total fungus
 : Max.100 cfu / g
Enterobacteriaceae
: Absent in 1g
E.Coli : Absent in 10 g
Salmonella : Absent in 10 g
Staphylococcus aureus : Absent in 10 g
Pseudomonas aeruginosa : Absent in 10 g
 

1. Method of testing as per USP 29

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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