Appearance

A white or almost white crystalline powder.

A white crystalline powder.

Identification

A. (IR Spectrum)

To match with Reference Standard

Complies

B.

A dark red color is produced

Complies

C.

Chlorhexidine mp 132°C~136°C

132.6°C~134.0°C

D.

Gives reaction of chlorides.

Complies

Tests

Chloroaniline

Maximum 500 ppm

Complies

Related substances

(by HTLC)

To match with Reference Standard

Complies

Loss on drying

Maximum 1.0 %

0.56%

Sulphated ash

Maximum 0.1%

0.07%

Assay

Chlorhexidine dihydrochloride contains not less than 98.0% and not more than equivalent of 101.0% of 1,1'-(hexane-1,6-diyl)bis[5-(4-chlorophenyl)- biguaanide] dihydrochloride, calculated with reference to the dried substance

99.4%

Remarks: The material complies with respect to the requirements of EP7.0 standard.