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Calcium Glubionate (Ampoule grade / Injection grade)
Product Name Calcium Glubionate (Ampoule grade / Injection grade)
Other name Calcium Glucono Galacto Gluconate
CAS No. 12569 – 38- 9
Molecular Formula C12 H21 O12, C6 H11 O7) Ca H2O
Molecular Weight 610.51 (592.51 without water of hydration)
 
Analytical Specifications for Calcium Glubionate (Ampoule grade / Injection grade)
Tests   Specifications:
Description (Appearance) : White to off white powder

Odour

:

Odourless

Identification

: Shall pass the test

Clarity of 20% w/v solution in boiling water

 :

Clear to nearly clear
Colour of 20% w/v solution in boiling water : Colourless to nearly colourless
Behaviour on sterilization of 20% w/v solution in boiling water : Clear, colourless to nearly colourless or not intensely coloured than the comparison solution
Loss on drying : Max.7.0% w/w
pH of solution (5%) : Between 6.0 and 8.2
Heavy metals : Max. 10 ppm
Iron

: Max. 5 ppm
Oxalic Acid
 : Max. 70 ppm
Assay (on dried basis)
 : 98.0 % - 102.0%
Calcium content (on as is basis) : 6.16% - 6.90%
Bulk density (Loose) : 400- 800 kg/ m3
Particle Size Distribution
Passing thru’ U.S 60 # 		: More than 90 % w/w
 
Microbial Limit Tests
Bacterial Endotoxin Max. 0.0194 EU / mg
Total viable aerobic count
Max.100 cfu /g
Total fungus Max.50 cfu / g
E.Coli Absent in 10 g
Salmonella Absent in 10 g
Staphylococcus aureus Absent in 10 g
Pseudomonas aeruginosa Absent in 10 g
 

1. In house specs - Method of testing available on request.

2. 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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