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Calcium Gluconate Eur.Ph -For Injection (Monohydrate)
Product Name Calcium Gluconate Eur.Ph -For Injection (Monohydrate)
Other name Calcii gluconas ad iniectabile
CAS No. 18016-24-5
Molecular Formula C12 H22 CaO14 H2O
Molecular Weight 448.4
 
Analytical Specifications for Calcium Gluconate Eur.Ph -For Injection (Monohydrate)
Tests   Specifications:
Characters : A white, crystalline or granular powder, sparingly soluble in water, freely soluble in boiling water.

Identification

  

 

TLC
Calcium

 :
:		 Shall pass the test.
Shall pass the test.

Solution -S
Appearance of solution
(10% w/v solution in boiling water)

    

a. Solution S at 600C
b. After cooling at 200C

 :
:

Not more intensely coloured than reference solution B7
Not more opalescent than reference suspension II

pH (1g in 20 ml) : Between 6.4 and 8.3
Organic impurities and boric acid : Shall pass the test
Oxalate : Max.100 ppm
Sucrose and reducing sugars : Shall meet the requirement
Chlorides : Max.50 ppm
Phosphates : Max.100 ppm
Sulphates : Max.50 ppm
Iron : Max.5 ppm
Magnesium and alkali metals : Max.0.4%
Heavy metals : Max.10 ppm
Assay as C12H22CaO14H2O : 99.0% -101.0%
 
Additional tests (In-house)
Calcium content (on as is basis) 8.85% - 9.03 %
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
Bacterial Endotoxin Max. 167 IU /g
Max. 75 IU / g (in house)
 
Microbial contamination
Total viable aerobic count Not more than 102 micro- organisms per gram
E.Coli Absent in 10 g
Pseudomonas aeruginosa Absent in 10 g
Staphylococcus aureus
 Absent in 10 g
 
Additional tests ( In-house)
Total fungus Max.50 cfu / g
Enterobacteriaceae Absent in 1g
Salmonella Absent in 50 g
 

1. Method of testing as per Eur.Ph 5th Edn.

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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