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Calcium Ascorbate USP
Product Name Calcium Ascorbate USP
CAS No. 5743-27-1
Molecular Formula C12 H14 CaO12 2H2O
Molecular Weight 426.34
 
Analytical specification for Calcium Ascorbate USP
Tests   Requirements
Description : White to slightly yellow, practically odorless powder.
Solubility : Freely soluble in water; slightly soluble in alcohol; insoluble in ether
Identification : Shall be pass the test
Specific Rotation : Between +95° and +97°
pH (10% w/v solution in water) : Between 6.8 and 7.4
Loss on drying : Max.0.1%
Arsenic : Max.3 ppm
Heavy metals : Max.0.001%
Limit of fluoride : Max.10 ppm
Residual solvents : Should meet the requirements
Assay as C12H14CaO12 -2H2O (Calculated on as is basis) : 98.0 % - 101 %
 
Additional tests (In-house)
Calcium content (on as is basis) 9.21% - 9.49%
Particle Size Distribution
Passing thru’ U.S 16 #		 More than 80 % w/w
Bulk density (Loose) 500 - 900 kg/ m3
 
Microbial Limit Tests (in- house specs.)
Total viable aerobic count Max.1000 cfu /g
Total fungus Max.100 cfu / 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.

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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