Copper Gluconate USP - Global Calcium

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Copper Gluconate USP

Product Name		Copper Gluconate USP
Other name		Copper - D - Gluconate
CAS No.		527-09-3
Molecular Formula		C12 H22 CuO14
Molecular Weight		453.84

Tests		Requirements
Description	:	Blue or bluish green or greenish blue powder.
Solubility	:	Soluble in water
Identification	:	Shall pass the test
Chloride	:	Max.0.07%
Sulphate	:	Max.0.05%
Arsenic	:	Max.3 ppm
Lead	:	Max.0.0025%
Reducing substances	:	Max.1.0%
Residual solvents	:	Shall meet the requirements
Assay as C12H22CuO14	:	98.0% -102.0%

Additional tests (In-house)
Clarity of 5% w/v solution at 250C	Clear to nearly clear
Colour of 5% w/v solution at 250C	Very slight blue/ Bluish green / greenish blue colour
Copper content (on as is basis)	13.72%- 14.28%
pH (1% solution)	App.4.0
Particle Size Distribution Passing thru’ U.S # 35	More than 90 % w/w
Bulk density (Loose)	500– 900 kg/ m3

Microbial Limit Tests:
Total viable aerobic count	:	Max.500 cfu /g
Total fungus	:	Max.50 cfu / g
Enterobacteriaceae	:	Absent in 1g
E.Coli	:	Absent in 10 g
Salmonella	:	Absent in 50 g
Pseudomonas aeruginosa	:	Absent in 10 g
Staphylococcus aureus	:	Absent in 10 gm

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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