TEST

SPECIFICATIONS

Characters

A white or almost white

crystalline powder,

hygroscopic. Freely soluble

in water, very soluble in methanol, freely soluble in methylene chloride.

Identification

A)    IR graph should be concordant

 With reference spectrum of Xylazine Hydrochloride.

B) The paper turns violet-red.

Appearance of solution    

Solution S should not be more

 opalescent than reference

suspension II and should be colourless.

pH

4.5 to 5.5

Melting range

164℃-168℃

Impurity A

Not more than 100 ppm.

Related substances

A)    Impurities C and E (for each impurity) : Not more than 0.2%.

B)    Impurities B and D (for each impurity) : Not more than 0.2%.

C)    Any other impurity : Not more than 0.2%.

D)    Total impurities other

than B,C,D and E : Not more than 0.2%.

Loss on drying

Not more than 0.5%

Heavy metals

Not more than 10ppm

Sulphated ash

Not more than 0.100%

Assay

98.0% ~ 102.0%

calculated on dried basis

Residual solvents

Toluene

Ethyl acetate

Acetone

Xylene

Not more than 300ppm

Not more than 300ppm

Not more than 300ppm

Not more than 300ppm

BIOLOGICAL TESTS

NOT MORE THAN 104 EU/µg