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Calcium D-Saccharate
Product Name Calcium D-Saccharate
Other name

Calcium D – Glucarate (1:1) Tetrahydrate

CAS No.

5793–89–5

Molecular Formula C6 H8 CaO8.4H2O
Molecular Weight 320.26
 
Analytical Specifications for Calcium D-Saccharate

Tests

 

Limits (As per USP 29)

Description

:

A white powder, odourless.

Identification

:

Shall pass the test.

Specific optical rotation

:

+ 18.5o to 22.5o

Chloride

:

Max. 0.07 %

Sulphate

:

Max. 0.12 %

Heavy Metals

:

Max. 20 ppm

Sucrose / Reducing sugar

:

Shall pass the test.

Organic Volatile impurities

:

Shall pass the test

Assay

:

98.5 % - 102.0 %

 

Additional Tests (In–House)

Mineral Content

12.0 % – 12.5 %

Lead

Max. 5 ppm

Arsenic

Max. 3 ppm

Bulk density (Loose Kg/m3)

400– 600 Kg/m3

Particle Size
# 40 mesh (US) (pass through)


Minimum 99.0 %

 
Microbial Limit Tests:

Total plate count

:

Max. 1000/g

Yeasts and Moulds

:

Max. 100/g

Staphylococcus aureus

: Absent

E. Coli

: Absent
Bacterial Endotoxin : 320 EU/g
 

1. Method of testing 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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