Chlorobutanol Hemihydrate, sifted

EP, USP/NF, Injectable Grade

CAS #:

57-15-8

Molecular Formula:

C4H7Cl3O

Synonym:

Chlorobutanol

Molecular Weight:

177,46 g/mol

Overview

Chlorobutanol Hemihydrate, NF is a very effective preservative in many pharmaceutical products for eyes, ears and nose, dental preparations.

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 100
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 % 4.5 - 5.5
Chlorobutanol % 98.0 - 101.0 (wf)
Residual Solvent:
Acetone ppm ≤ 1000
Chloroform ppm ≤ 60
Mesityl oxide ppm ≤ 60
Diacetone alcohol ppm ≤ 1000
As per USP:
Characteristics colorless to white crystals
Identification IR-Spektrum
Iodoform reaction
Purity:
Reaction Neutral to Litmus
Chloride ppm NMT 700
Assay:
Water % NMT 6.0
Chlorobutanol % 98.0 - 100.5 (wf)
Residual Solvent:
Acetone ppm ≤ 1000
Chloroform ppm ≤ 60
Mesityl oxide ppm ≤ 60
Diacetone alcohol ppm ≤ 1000

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 preventdamage to or leakage from the container.
  • Avoid prolonged exposure to air.

Pack Sizes: 100 gm and 1 Kg

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