Chlorobutanol Anhydrous

EP, USP/NF, Injectable Grade

CAS #:

57-15-8

Molecular Formula:

C4H7Cl3O

Synonym:

Chloretone, 1,1,1-Trichloro-2-methyl-2-propanol

Molecular Weight:

177,46 g/mol

Overview

Chlorobutanol is a colourless to white crystalline compound with a camphoraceous odour and taste. It is a widely used preservative in various pharmaceutical solutions, especially injectables. Also, it is an active ingredient in certain oral sedatives and topical anaesthetics. It is a very effective preservative in many pharmaceutical products for eyes, ears and nose, dental preparations. The anhydrous form is useful in formulations where the absence of water is desired

Characters Unit Specification
As per EP
Characteristics white or almost white crystalline powder or colourless crystals
Identification Iodoform reaction
Water
Black precipitate
Red Colour of Pyridine layer
Purity:
Chloride ppm NMT 300
Clarity of solution NMT RS II
Colour of solution NMT BY 5
Acidity NMT 1.0 ml of 0.01M-NaOH
Sulphated ash % NMT 0.1
Assay:
Water % NMT 1.0
Chlorobutanol % 98.0 - 101.0 (wf)
Residual Solvent:
Acetone ppm ≤ 1000
Chloroform ppm ≤ 60
Ethanol ppm ≤ 1000
Mesityl oxide ppm ≤ 60
Diacetone alcohol ppm ≤ 1000
As per USP:
Characteristics colorless to white crystals
Identification IR-Spektrum
Retention time corresponds to the standard solution
Purity:
Reaction Neutral to Litmus
Chloride ppm NMT 700
Assay:
Water % NMT 1.0
Chlorobutanol % 98.0 - 100.5 (wf)
Residual Solvent:
Acetone ppm ≤ 1000
Chloroform ppm ≤ 60
Ethanol ppm ≤ 1000
Mesityl oxide ppm ≤ 60
Diacetone alcohol ppm ≤ 1000
Endotoxin Actual value

Storage/Shipping Conditions:

  • Containers should be stored in a cool, dry, well-ventilated area away from flammable materials andsources of heat or flame.
  • Store away from food stuffs or animal feed.
  • Exercise due caution to prevent damage to or leakage from the container.
  • Avoid prolonged exposure to air.

Pack Sizes: 100 gm and 1 Kg

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