Calcium Gluconate USP (injectable grade)

Calcium Gluconate USP (Injectable grade)(Anhydrous/ Monohydrate)

(Intended for use in preparing injectable dosage forms)

Product Name		Calcium Gluconate USP (injectable grade) (Anhydrous/ Monohydrate)
Other name		D- Gluconic acid Calcium salt
CAS No.		299-28-5 ( Anhydrous) / 18016-24-5 (Monohydrate)
Molecular Formula		C12 H22 CaO14 ( AH) / C12 H22 CaO14 H2O (MH)
Molecular Weight		430.37 (AH) / 448.39 (MH)

Analytical Specifications for Calcium Gluconate USP (Injectable grade) (Anhydrous/ Monohydrate)
Tests		Specifications:
Characters	:	A white crystalline or granular powder.
Solubility	:	Sparingly (slowly) soluble in water, freely soluble in boiling water
Identification
TLC Calcium	: :	Shall pass the test. Shall pass the test.
Loss on drying	:	Max. 3.0 % (Anhydrous) Max. 1.0 % (Monohydrate)
Chloride	:	Max.0.005%
Oxalate	:	Max.0.01%
Phosphate	:	Max.0.01%
Sulfate	:	Max.0.005%
Arsenic	:	Max.3 ppm
Heavy metals	:	Max.0.001%
Magnesium and alkali metals	:	Max.0.4%
Iron	:	Max.5 ppm
Reducing substances	:	Max.1.0%
Organic volatile impurities	:	Shall meet the requirements
Residual solvents	:	Shall meet the requirements
Assay as C12 H22 CaO14 (on dried basis)	:	98 .0 % -102.0% (Anhydrous)
Assay as C12 H22 CaO14H2O	:	99.0 % - 101.0% (Monohydrate)

Additional tests (In-house)
Clarity of 10% w/v solution in boiling water	Clear
Colour of 10% w/v solution in boiling water	Colourless
Calcium content (on as is basis)	8.85 % - 9.50% (Anhydrous) 8.85 % - 9.03 % (Monohydrate)
pH (5% solution)	App.7.0
Lead	Max.0.2 ppm
Mercury	Max. 1 ppm
Particle Size Distribution Passing thru’ U.S 16 #	More than 70 % w/w
Bulk density (Loose)	250 - 600 kg/ m3

Microbial Limit Tests (in- house specs.)
Bacterial Endotoxin	Max.0.075 EU / mg
Total viable aerobic count	Max.100 cfu /g
Total fungus	Max.50 cfu / g
Enterobacteriaceae	Absent in 1 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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