Sl.No.

TEST

SPECIFICATION

RESULTS

01.

Description

White Crystalline Powder

White Crystalline Powder

02.

Solubility

Soluble in water and methanol

Soluble in water and methanol

03.

Identification by IR

The IR spectrum of the sample should be concordant with the working standard.

Complies

04.

ph

ph(5%water)

6.0-7.1

5.9-7.0

6.25

6.44

05.

Moisture Content by

KF

NMT1.0% w/w

0.01% w/w

06.

1,4-Dioxane

Should be absent

Not detected

07.

Purity by HPLC

NLT 98.00%

99%

08.

Assay by HPLC

98 – 101% w/w

99.77%

09.

Melting point

105-110℃

107℃

10.

Heavy metal

Complies

11.

Specific rotation

-28- -32

-29.27