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
