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Potassium Citrate USP (Monohydrate)
Product Name Potassium Citrate USP (Monohydrate)
Other name

1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tripotassium salt

CAS No.

6100-05-6

Molecular Formula C6 H5 K3 O7.H2O
Molecular Weight 324.41
 
Analytical Specifications for Potassium Citrate USP (Monohydrate)

Tests

 

Limits (As per USP 29)

Description

:

White crystalline powder

Solubility

:

Very soluble in water, soluble in glycerin; Practically insoluble in ethanol (95.0%)

Identification
1. Potassium
2. Citrate


:
:


Shall pass the test
Shall pass the test

Alkalinity

:

Shall pass the test

Loss on drying (at 180oC for 4 hours)

:

Between 3.0 % to 6.0 %

Tartrate

:

Shall be absent

Heavy metals

:

Max. 0.001 %

Organic volatile Impurities

:

Meets the requirements

Assay (On dried basis)

:

99.0 % to 100.5 %

 

Additional Tests (In–House)

Lead

Max. 2 ppm

Arsenic

Max. 3 ppm

pH

8.5 to 9.5

Mineral Content

35.5% – 36 %

Bulk density (Loose Kg/m3)

700 to 900 Kg/m3

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


Minimum 65.0 %

 
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 as per USP 29 as 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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