Active Pharma Ingredient

TEST

SPECIFICATIONS

Description

A white or almost white powder.

Solubility

Practically insoluble in water, freely soluble in Methylene chloride, sparingly soluble in Tetrahydrofuran, very slightly soluble in alcohol

Identification

By IR

The infra Red absorption spectrum of the finely ground sample in KBr dispersion compressed into a disc should exhibit maxima only at the same wavelengths as that of similar preparation of Itraconazole Working Standard

Appearance of solution

A solution of 2 g in 20ml Methylene chloride should be clear and not more intensely coloured than BY6

Optical Rotation

-0.10º to + 0.10º

Related substances HPLC

Maximum Single impurity : NMT 0.5%

Total Impurities : NMT 1.25%

Loss on drying

NMT 0.5%w/w

Sulphated Ash

NMT 0.1%w/w

Assay on dried basis

NLT 98.5% and NMT 101.5% w/w

TEST

SPECIFICATIONS

Description

A white to off-white crystalline powder

Solubility

Freely soluble in methanol, slightly soluble in ethanol

Identification

IR Spectrum

The infra-red absorbance spectrum should be concordant with the reference spectrum

Specific Optical Rotation

Between -6.0° and -12.0° on anhydrous basis

Related substances by HPLC

a) Major individual impurity

b) Total impurities

NMT 0.5%

NMT 2.0%

Heavy metal

NMT 20 ppm

Water content (By KFR)

Between 3.0 and 7.0% w/w

Asay By HPLC

(On Anhydrous Basis)

NLT 98.0% AND NMT 102.0%

Description

A white to off-white crystalline powder

Solubility

Freely soluble in methanol, slightly soluble in ethanol