Itraconazole

SKU:AIF010
Description:

ITEMS	LIMIT
Description	A white or almost white powder
Solubility	Practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in tetrahydrofuran and very slightly soluble in alcohol.
Identification
First Identification (B)	IR absorption The IR absorption spectrum of the sample should match with the spectrum of the Itraconazole working standard.
Second Identification A,C,D	A) Melting range: Between 166.0°C and 170.0°C
	C) TLC: The principle spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principle spot in the chromatogram obtained with reference solution (a) and reference solution (b) shows two clearly separated spots.
	D) Chlorides: White crude precipitate observed which is easily dissolved in excess of ammonia solution.
Clarity and appearance of solution	10% w/v solution in Methylene chloride should be clear and not more intensely coloured than reference solution BY6
Optiacl rotation (10% in Methylene chloride)	-0.10°C to +0.10°C
Related substances (By HPLC)	Any single impurity: NMT 0.50%
Related substances (By HPLC)	Total impurities: NMT 1.25%
Loss on drying (100 to 1050C for 4 hrs)	NMT 0.50% w/w
Sulphated ash	NMT 0.10% w/w
Assay (on dried basis)	NLT 98.5% and NMT 101.5% w/w

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