Sr.No

TEST

OBSERVATION

SPECIFICATION

01.

APPEARANCE

A White

cryatalline powder

A white or slightly yellow,odorlessor practicallyodorless,crystalline powder.

02.

SOLUBILITY

Complies

Slightly soluble in water,freely soluble in

methanol,soluble in chloroform sparingly in

alcohol;practically in oluble in elher

03.

IDENTIFICATION

Ir Identification

(By K Br disc)

Complies

The IR spectrum of the preparation of test

specimen cxhibits maxima only at the same

wavelengths as that of similar preparation of

the corresponding Cyprol cptadine Hcl

reference standard

B.ULTRAVIOLET

ABOSORPTION

(Calculated on dried basis,%16 ug per ml in alcohol)

Complies

C.COLOR TEST

Complies

A Blue florescence is observed

04.

ACIDITY(0.05% as HCL,ml)

0.13ml

Not more than 0.15ml

05.

06.

RESIDUE ON IGNITION

(in % w/w)

0.06%

07.

HEAVY METALS(%,w/w)

<0.003%

Not more than <0.003%

08.

ADDTTIONAL TEST

Methanol

Isopropyl Alcohol

Tolucnc

Chloroform

45ppm

102ppm

12ppm

4ppm

NMT 3000 ppm

NMT 5000 ppm

NMT 890 ppm

NMT 60 ppm

09.

ASSAY(By titrimetry,on dried

basis,% w/w)

99.6%

Not less than 98.5% and Not more than 100.5%