BIMAL PHARMA PVT. LTD. MUMBAI, INDIA

   

TYPICAL CERTIFICATE OF ANALYSIS

                     Name of the Product     :    SUCRALOSE FCC VI / USP                                            

RESULT OF ANALYSIS

Sr.

No.

TEST

SPECIFICATIONS

RESULTS

1.

Appearance

White Crystalline Powder, Odourless.

 

White Crystalline

Powder, Odourless.

2.

Specific Rotation

 

+ 84 .0 to + 87.5

86.6

3.

Water Content

 

Less than 2.0 %

0.41%

4.

Identifications

As per USP and FCC VI

Complies

 

5.

Residue on Ignition

Less than 0.7%

0.2%

 

6.

Methanol Content

Less than 0.1%

0.03%

 

7.

Heavy Metals

Less than 0.001%  (10 ppm)

Less than 0.001%

(10 ppm)

 

8.

Lead Content 

Less than 1 ppm

Complies

 

9.

Related Compounds

Less than 0.5%

Complies

 

10.

Hydrolysis Products

Less than 0.1%

Complies

 

11.

Residual Solvents

As per USP

Complies

 

12.

Assay

98.0%  to 102.0%

99.80%