SR.NO

TESTS

SPECIFICATION

RESULTS

1.

Description

Yellow color crystalline powder

Complies

2.

Identification

a)      By TLC

The principal spot obtained from the sample solution should correspond that of standard solution

Complies

b)     By HPLC

The retention time of the major peak in the chromatogram of the sample should correspond to that in the chromatogram of the standard.

Complies

c)      Melting Range

Between 137C to 140C

138C - 139C

3.

Loss on drying at 80C

NMT 0.50 %

0.45%

4.

Related Substance by

a)

2-Amino-3,5-dibromo benzoic acid (IMP - A at RRT about 0.15)

Not more than 0.50 %

0.20%

b)

2-Amino-3,5-dibromo benzyl alcohol (IMP - A at RRT about 0.5)

Not more than 0.50 %

0.21%

c)

Unknown impurity

Not more than 0.50 %

0.10%

d)

Total impurity

Not more than 2.00%

0.80%

5

Assay By titration

Between 98% to 102% (w/w)

99.80%

6

Sulphated Ash

Not more than 0.1%

0.08%

SR.NO

TESTS

SPECIFICATION

RESULTS

1.

Description

Yellow color crystalline powder

Complies

2.

Identification

a)      By TLC

The principal spot obtained from the sample solution should correspond that of standard solution

Complies

b)     By HPLC

The retention time of the major peak in the chromatogram of the sample should correspond to that in the chromatogram of the standard.

Complies

c)      Melting Range

Between 137C to 140C

138C - 139C

3.

Loss on drying at 80C

NMT 0.50 %

0.45%

4.

Related Substance by

a)

2-Amino-3,5-dibromo benzoic acid (IMP - A at RRT about 0.15)

Not more than 0.50 %

0.20%

b)

2-Amino-3,5-dibromo benzyl alcohol (IMP - A at RRT about 0.5)

Not more than 0.50 %

0.21%

c)

Unknown impurity

Not more than 0.50 %

0.10%

d)

Total impurity

Not more than 2.00%

0.80%

5

Assay By titration

Between 98% to 102% (w/w)

99.80%

6

Sulphated Ash

Not more than 0.1%

0.08%