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Calcium Citrate USP (Tetrahydrate) (Powder)
Product Name Calcium Citrate USP (Tetrahydrate) (Powder)
Other name 2-Hydroxy-1,2,3-propane tricarboxylic acid Calcium salt (2:3), tetrahydrate
CAS No.

5785 – 44 – 4

Molecular Formula C12 H10 Ca3 O14.4H2O
Molecular Weight 570.49
 
Analytical Specifications for Calcium Citrate USP (Tetrahydrate) (Powder)

Tests

 

Limits (As per USP 29)

Description

:

White, odourless, crystalline powder.

Solubility

:

Slightly soluble in water, freely soluble in 3N hydrochloric acid, insoluble in ethanol (95 %)

Identification

:

Shall pass the test

Loss on drying (At 1500C for 4 hrs.)

:

10.0 % to 13.3 %

Arsenic

:

Max. 3.0 ppm

Fluoride

:

Max. 0.003 %

Acid – Insoluble substances

:

Max. 0.2 %

Heavy metals

:

Max. 20 ppm

Organic volatile impurities

:

Shall pass the test

Assay as Ca3 (C6 H5 O7)2
(Previously dried at 1500C to
constant weight)

:

97.5 % to 100.5 %

 

Additional Tests (In–House)

Calcium Content (anhydrous)

23.51 % - 24.24 %

Calcium Content (tetrahydrate)

20.55 % - 21.18 %

Lead

Max. 1 ppm

Mineral Content

20 % to 21 %

Bulk density (Loose Kg/m 3)

400 to 500 Kg/m3

Particle size
Through 80 mesh
Retention 10 mesh


Min. 80.0 %
Max. 1.0 %

 
Microbial Limit Tests:
Total aerobic count :

Max. 1000 CFU/g

Total moulds and yeasts

:

Max. 100 CFU/g

E.Coli : Absent
Salmonella : Absent
 

1. Method of testing as per USP 29 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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