Preservative excipient
Chlorobutanol Hemihydrate is a pharmaceutical preservative used in regulated formulations where protection against microbial contamination is required. Chemically, chlorobutanol is also known as 1,1,1-trichloro-2-methylpropan-2-ol, and the Ph. Eur. material is supplied as the hemihydrate form.
Chlorobutanol Hemihydrate is a pharmaceutical preservative used in regulated formulations where protection against microbial contamination is required. Chemically, chlorobutanol is also known as 1,1,1-trichloro-2-methylpropan-2-ol, and the Ph. Eur. material is supplied as the hemihydrate form.
in established source material, chlorobutanol has also been described as having weak local anesthetic and sedative-hypnotic properties, but in current formulation practice its main relevance is as a preservative excipient.
Supply context
BHM Chemicals is a supplier of Ph. Eur. quality Chlorobutanol Hemihydrate suitable for use in pharmaceutical formulations.
Minimum order quantity: 25 kg
Chlorobutanol Hemihydrate is used in formulations where antimicrobial preservation is needed to help maintain product quality during storage and use. It has long been used in ophthalmic solutions and ointments, and current regulated product labels also show its use in selected nasal and injectable products. This established formulation history makes chlorobutanol hemihydrate a relevant excipient for manufacturers working with preserved pharmaceutical dosage forms.
Chlorobutanol has a long-established role as a preservative in ophthalmic preparations. It is found in eye drops and ophthalmic ointments, where it helps protect preserved formulations against microbial contamination. Published product information and reference sources commonly describe chlorobutanol at around 0.5% in ophthalmic products.
Chlorobutanol Hemihydrate is also used in certain nasal preparations as an inactive preservative ingredient. Current product listings show it in preserved nasal drops, supporting its relevance in non-ophthalmic aqueous formulations intended for local administration.
Although it should not be presented as a universal injectable preservative, chlorobutanol hemihydrate is present in certain marketed injectable regulated products. This supports describing it as suitable for selected pharmaceutical formulations depending on formulation design and regulatory requirements.
Chlorobutanol is also used in other pharmaceutical preparations where preservation and formulation protection are required. For website positioning, it is best to describe it broadly as a pharmaceutical preservative excipient rather than extending into loosely supported industrial or laboratory claims.
Chlorobutanol is valued for its antibacterial and antifungal preservative properties. This preservative function is the main reason for its continued use in pharmaceutical formulations that require microbiological protection.
Chlorobutanol is only sparingly soluble in water at room temperature, but it is more readily soluble in alcohol, glycerol, hot water and volatile oils. This solubility profile is important in formulation design and explains why suitable solvent systems and excipient compatibility need to be considered during development.
Chlorobutanol has an established record in preserved regulated products, especially ophthalmic products. At the same time, formulation performance depends on factors such as composition, pH, packaging and intended route of administration. More recent literature also notes that chlorobutanol may be less favored in some ophthalmic systems because of stability and tolerability considerations, so precise formulation design remains important.
Chlorobutanol Hemihydrate should be used in accordance with the applicable pharmacopoeial specification, finished-product requirements and local regulatory framework. For a supplier website, the most accurate and professional approach is to present it as a Ph. Eur. preservative excipient for pharmaceutical formulations, while avoiding overly broad unsupported performance claims or unnecessary emphasis on older sedative or anesthetic uses.
Chlorobutanol Hemihydrate Ph. Eur. remains a relevant pharmaceutical preservative for manufacturers developing preserved regulated formulations. Its strongest commercial positioning is based on defined pharmacopoeial quality, established use in ophthalmic and other pharmaceutical preparations, and practical preservative performance in suitable formulation systems. For BHM Chemicals, the clearest message is that you supply Chlorobutanol Hemihydrate Ph. Eur. as a preservative excipient, not as a functional ingredient.
BHM Chemicals
| Parameter | Specification |
|---|---|
| CAS No. | 57-15-8 |
| Synonyms | Trichloro-2-methyl-2-propanol; Chlorobutanol Hemihydrate |
| Characteristics | White or almost white crystalline powder or colourless crystals, sublimes readily. Slightly soluble in water, very soluble in ethanol (96%), soluble in glycerol (85%). Melting point: about 78 °C (without previous drying). |
| Content (Assay) | 98.0% to 101.0% (dried basis) |
| Identification | Conforms to Ph. Eur. tests |
| Appearance of solution | As per Ph. Eur. test: Solution S is not more opalescent than reference suspension II and not more intensely coloured than reference solution BY5 |
| Acidity | As per Ph. Eur. test: Not more than 1.0 ml of 0.01 M NaOH is required to change the colour of the indicator to blue |
| Chlorides | Maximum 100ppm |
| Water | 4.5% to 5.5% |
| Sulphated ash | Maximum 0.1% |
Full documentation is available on request. Product suitability should be assessed by the customer for the intended application.
Documentation and enquiry
info@bhm-chemicals.com - +48 (0) 519 702 757
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