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. |
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ASSAY |
98.0%-100.5% |
98.0% -101.0% |