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:
Pack Sizes: 100 gm and 1 Kg