Calcium Lactate USP FCC (Pentahydrate)

Product Name		Calcium Lactate USP FCC (Pentahydrate)
Other name		Propanoic acid, 2 - hydroxy-, calcium salt (2:1), hydrate
CAS No.		5743-47-5
Molecular Formula		C6 H10CaO6.5H2O
Molecular Weight		308.3

Analytical Specifications for Calcium Lactate USP FCC (Pentahydrate)

Tests	Requirements
Description	White, practically odorless, granules or powder, somewhat efflorescent.
Solubility	Soluble in water, Freely soluble in boiling water
Identification	Shall pass the test
Acidity	Max 0.45% as Lactic acid
Loss on drying ( w/w)	Between 22.0 % and 27.0%
Volatile fatty acid	Shall pass the test
Heavy metals	Max.0.002%
Magnesium and alkali salts	Max.1.0%
Organic volatile impurities	Shall meet the requirements
Residual solvents	Shall meet the requirements
Assay as C6H10CaO6 (Calculated on dried basis)	98.0% - 101.0%
Fluoride	Max. 0.0015%
Lead	Max. 2 mg / kg ( 2 ppm)

Additional Tests - (In House)
Calcium content ( on as is basis)	:	13.04 % - 14.51%
pH (5% solution)	:	App.6.5
Particle Size Distribution Passing thru U.S 16 #	:	More than 80 % w/w
Bulk density (Loose)	:	400-800 kg/ m3

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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