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SPECIFICATIONS

 

CALCIUM D-GLUCARATE

(CALCIUM D-SACCHARATE USP)

  

 

Date:  November, 2011

 

ITEMS

SPECIFICATIONS

Appearance

White, odorless powder

Identification

Positive for Calcium & Saccharate

Specific Rotation

+18.5° to +22.5°

Chloride

700 ppm Max.

Sulfate

1,200 ppm Max.

Sucrose  /

Reducing Sugar

As per USP

Organic Volatile Impurities

As per USP

Heavy Metals

20 ppm Max.

Lead

0.2 ppm Max.

Arsenic

3 ppm Max.

Calcium Content

12.4 – 12.8%

Water Content

(as water of crystallization)

~ 22.51%

Assay

98.5 – 102.0%

Aerobic Plate Count

3,000 CFU/g Max.

Yeast & Mold

300 CFU/g Max.

E. Coli

Negative / 10 g

Salmonella

Negative / 10 g

Staph. Aureus

Negative / 10 g

P. Aeruginosa

Negative / 10 g

 

 

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