Product Portfolio with regulatory compliance

Chlorobutanol hemihydrate

Bulk Active : Chlorobutanol hemihydrate
MOLECULAR FORMULA : C21H 38 ClN, H2O
MOLECULAR WEIGHT : 358.00
Pharmacologic Activity : Antiseptic
CAS No : 123-03-5
Specifications : BP/EP/USP
Regulatory compliance : eDMF(CTD)

TEST USP 36 BP 2013/EP 7.4
     
CHARACTERS Colorless to white crystals, having a characteristic, somewhat camphoraceous, odor and taste White or almost white crystalline powder or colourless crystals, sublimes readily
     
SOLUBILITY Freely soluble in alcohol, in ether, in chloroform, and in volatile oils; soluble in glycerin; slightly soluble in water. Slightly soluble in water, very soluble in ethanol (96 per cent), soluble in glycerol (85 per cent).
     
IDENTIFICATION
MELTING POINT\

TEST A




TEST B



TEST C




TEST D(WATER)

It melts at about 76° .

UV absorption spectra should be concordant
with Reference standard spectrum



A yellow precipitate of iodoform. recognizable by its odor appears


------




------


about 78 °C (without previous drying).

The pyridine layer becomes red on addition of 20 mg of substance to a mixture of 1 ml of pyridine and 2 ml of strong sodium hydroxide solution.

A black precipitate is formed on addition of 20 mg of substance to 5 ml of
ammoniacal silver nitrate solution.

A yellowish precipitate is formed on addition of about 20 mg of substance to a mixture of 3 ml of 1 M sodium hydroxide and 5 ml of water and 2 ml of iodinated potassium iodide solution

It complies with the water test

     
Appearance of solution ----- Solution S is not more opalescent than reference suspension II and not more intensely coloured than reference solution BY5
     
ACIDITY ----- Not more than 1.0 ml of 0.01 M sodium hydroxide is required to change the colour of the indicator to blue
     
CHLORIDE NMT 0.07% NMT 100PPM
     
SULPHATED ASH --------- NMT 0.1%
     
WATER NMT 6.0% 4.5%-5.5%
     
REACTION Mixture of 0.5gms with 25 ml of water
remains neutral to litmus.
---------
     
ASSAY
98.0%-100.5%
98.0% -101.0%