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Home Active Pharmaceutical Ingredients haloperidol
HALOPERIDOL
Product Name : Haloperidol BP/EP/USP
Chemical Name : 4-[4-(4-chlorophenyl)-4-hydroxy-1-piperidyl]-1-(4-fluorophenyl)-butan-1-one
CAS Number : 52-86-8
Chemical Formula : C21H23ClFNO2
Molecular Mass : 375.9 g/mol
Therapeutic Category : antipsychotic

Test Specification
Description A white or almost white powder.
Identification

The IR spectrum of sample should match with that of standard.

A curdy, white precipitate is produced

Solubility Practically insoluble in water, soluble in alcohol, in methanol & in methylene chloride.
Appearance of Solution The solution is clear and not more intensely coloured than reference solution Y7
Heavy Metals NMT 20 ppm
Loss On Drying NMT 0.5%
Assay on dried basis by HPLC NLT 99% and NMT 101%
Sulphated Ash NMT 0.1%
Related Substances by HPLC

Individual impurity : NMT 0.5%

Total impurities : NMT 1.0%

Related Substances by TLC

Position & size of principal spot obtained with sample shall be similar with that of standard.

Chloride

A curdy, white precipitate is produced.

Melting Range Between 150°C & 153°C
Clarity & Colour Solution

A violet colour is produced and becomes brownish red after 20 min

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