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Calcium Levulinate USP (Dihydrate) Oral grade
Product Name Calcium Levulinate USP (Dihydrate) Oral grade
Other name

Pentanoic acid, 4 - Oxo -, Calcium salt (2:1) dihydrate

CAS No.

5743 - 49 - 7

Molecular Formula C10 H14 CaO6.2H2O
Molecular Weight 306.32
 
Analytical Specifications for Calcium Levulinate USP (Dihydrate) Oral grade

Tests

  

Limits (As per USP 29)

Description

:

A White Powder.

Identification

:

Shall pass the test.

Melting range

:

Between 1190C and 1250C

pH (1 in 10)

:

Between 7.0 and 8.5

Chloride

:

Max. 700 ppm

Sulphate

:

Max. 500 ppm

Heavy metals

:

Max. 20 ppm

Reducing sugars

:

Shall pass the test.

Loss on drying

 

Between 10.5 % to 12.0 %

Organic volatile impurities

:

Shall pass the test.

Assay (On dried basis)

:

97.5 % to 100.50 %

 
Additional Tests (In-House)
Mineral Content : 12.7 % to 13.0 %
Lead : Max. 5 ppm
Arsenic : Max. 3 ppm
Bulk density (Loose Kg/m3) : 500 to 600 Kg/m3
Particle Size
# 40 mesh (US) (pass through)
:
Minimum 90.0 %
 
Microbial Limit Tests:
Total aerobic count :

Max. 1000 CFU/g

Total moulds and yeasts

:

Max. 100 CFU/g

E.Coli : Absent
Salmonella : Absent
 

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 20-25oC.
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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