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Chloral hydrate | CAS No: 302-17-0 | GMP-certified suppliers
A medication that provides short‑term relief of insomnia and supports preoperative sedation needs, offering controlled calming effects for targeted procedural use.
Therapeutic categories
AlcoholsCentral Nervous System AgentsCentral Nervous System DepressantsDrugs that are Mainly Renally ExcretedEthylene GlycolsGlycols
Generic name
Chloral hydrate
Molecule type
small molecule
CAS number
302-17-0
DrugBank ID
DB01563
Approval status
Approved drug, Illicit drug, Investigational drug, Vet_approved drug
ATC code
N05CC01
Primary indications
- Mainly used as a hypnotic in the treatment of insomnia
- However, it is only effective as a hypnotic for short-term use
- May be used as a routine sedative preoperatively to decrease anxiety and cause sedation and/or sleep with respiration depression or cough reflex
Product Snapshot
- Chloral hydrate is supplied as oral and topical small‑molecule formulations including solutions, syrups, capsules, and ointments
- It is used as a short-term hypnotic for insomnia and as a routine sedative for preoperative anxiety reduction
- It has approved, investigational, illicit, and veterinary-approved status across markets including the United States and Canada
Clinical Overview
Chloral hydrate (CAS 302‑17‑0) is a sedative–hypnotic primarily used for the short‑term management of insomnia. Its clinical utility focuses on initiating sleep or providing procedural sedation where controlled depression of consciousness is needed, including preoperative settings. Because of a narrow therapeutic index and dose‑dependent respiratory depression, its use is generally restricted and closely monitored. It is no longer recommended for routine anxiolysis. In research contexts, it is sometimes used as an anesthetic agent in animals, but this does not extend to human anesthesia.
Pharmacologically, chloral hydrate is a central nervous system depressant belonging to the chlorohydrin class of organic compounds. After administration, it is rapidly metabolized, mainly by hepatic alcohol dehydrogenase, to trichloroethanol, which is considered the primary active moiety. Trichloroethanol enhances inhibitory neurotransmission through potentiation of GABA‑A receptor activity, producing sedation and hypnosis. A further oxidative metabolite, trichloroacetic acid, is pharmacologically inactive but contributes to the overall elimination profile.
Absorption after oral dosing is rapid, with onset of sedative effects occurring within 30 to 60 minutes. Distribution is widespread, and both chloral hydrate and trichloroethanol cross the placenta and enter breast milk. Metabolites are primarily renally excreted, with elimination half‑lives influenced by hepatic function, renal clearance, and age. Accumulation can occur with repeated dosing due to slower elimination of trichloroacetic acid.
Safety considerations include risk of respiratory depression, paradoxical agitation in some patients, cardiac arrhythmias, gastrointestinal irritation, and hepatotoxic or nephrotoxic effects with excessive or prolonged exposure. Drug interactions may arise with other CNS depressants or substances affecting alcohol dehydrogenase activity. Overdose can result in profound CNS depression and requires supportive management.
Notable legacy brand names have existed, but contemporary use is limited and varies by region due to safer alternatives. For API procurement, suppliers should provide documentation verifying identity, impurity profile, stability data, and compliance with pharmacopeial or regional regulatory specifications to ensure suitability for formulation development.
Pharmacologically, chloral hydrate is a central nervous system depressant belonging to the chlorohydrin class of organic compounds. After administration, it is rapidly metabolized, mainly by hepatic alcohol dehydrogenase, to trichloroethanol, which is considered the primary active moiety. Trichloroethanol enhances inhibitory neurotransmission through potentiation of GABA‑A receptor activity, producing sedation and hypnosis. A further oxidative metabolite, trichloroacetic acid, is pharmacologically inactive but contributes to the overall elimination profile.
Absorption after oral dosing is rapid, with onset of sedative effects occurring within 30 to 60 minutes. Distribution is widespread, and both chloral hydrate and trichloroethanol cross the placenta and enter breast milk. Metabolites are primarily renally excreted, with elimination half‑lives influenced by hepatic function, renal clearance, and age. Accumulation can occur with repeated dosing due to slower elimination of trichloroacetic acid.
Safety considerations include risk of respiratory depression, paradoxical agitation in some patients, cardiac arrhythmias, gastrointestinal irritation, and hepatotoxic or nephrotoxic effects with excessive or prolonged exposure. Drug interactions may arise with other CNS depressants or substances affecting alcohol dehydrogenase activity. Overdose can result in profound CNS depression and requires supportive management.
Notable legacy brand names have existed, but contemporary use is limited and varies by region due to safer alternatives. For API procurement, suppliers should provide documentation verifying identity, impurity profile, stability data, and compliance with pharmacopeial or regional regulatory specifications to ensure suitability for formulation development.
Identification & chemistry
| Generic name | Chloral hydrate |
|---|---|
| Molecule type | Small molecule |
| CAS | 302-17-0 |
| UNII | 418M5916WG |
| DrugBank ID | DB01563 |
ADME / PK
| Absorption | Rapidly absorbed in the GI tract following oral or rectal administration. Chloral hydrate and its active metabolite, trichloroethanol, have been detected in CSF, umbilical cord blood, fetal blood, and amniotic fluid. |
|---|---|
| Metabolism | Metabolized by the liver and erythrocytes to form trichloroethanol, an active metabolite. This reaction is catalyzed by alcohol dehydrogenase and other enzymes. Oxidation of chloral hydrate and trichloroethanol to trichloroacetic acid in the liver and kidneys also occurs to a lesser extent. Trichloroethanol also undergoes glucuronidation to produce an inactive metabolism. |
| Route of elimination | Trichloroethanol, trichloroethanol glucuronide, and trichloroacetic acid are excreted in the urine. Some trichloroethanol glucuronide may be secreted into bile and excreted in the feces. |
Formulation & handling
- Highly water‑soluble small molecule suitable for simple aqueous oral solutions and syrups, with attention to its hygroscopic solid-state handling.
- Formulations should minimize exposure to heat and moisture to limit decomposition and maintain hydrate integrity.
- Topical and oral products require consideration of its reactivity with alcohol-containing excipients to avoid undesired interactions.
Regulatory status
| Lifecycle | Patent protection for the API has lapsed in both the United States and Canada, placing the product in a mature, largely genericized market. Commercial activity is characterized by established competition and limited remaining exclusivity drivers. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Chloral hydrate is an older sedative‑hypnotic with no active originator presence, and the supply landscape is dominated by numerous packagers and generic manufacturers. Branded and non‑brand products are marketed primarily in the US and Canada, with limited evidence of broader global distribution. Patent expiry long ago enables established generic competition, reflected in the wide range of suppliers. |
|---|
Chloral hydrate is a type of Hypnotics
Hypnotics belong to the pharmaceutical API category, which refers to a class of drugs primarily used to induce sleep or alleviate insomnia. These substances act on the central nervous system (CNS) to promote sedation and relaxation, aiding individuals in falling asleep and maintaining a healthy sleep pattern.
Hypnotics work through various mechanisms, targeting receptors and neurotransmitters involved in regulating sleep-wake cycles. They can enhance the activity of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter that reduces brain activity and induces sedation. By increasing GABAergic signaling, hypnotics help reduce anxiety, calm the mind, and facilitate sleep onset.
Commonly prescribed hypnotics include benzodiazepines, non-benzodiazepine receptor agonists, and melatonin receptor agonists. Benzodiazepines, such as diazepam and temazepam, bind to GABA receptors, intensifying the inhibitory effects of GABA. Non-benzodiazepine receptor agonists like zolpidem and zopiclone act selectively on certain GABA receptors, inducing sleep without causing significant muscle relaxation or antianxiety effects. Melatonin receptor agonists like ramelteon mimic the effects of melatonin, a hormone that regulates the sleep-wake cycle.
Hypnotics are widely prescribed for individuals experiencing sleep disturbances due to various conditions, including insomnia, jet lag, shift work disorder, or other sleep-related disorders. These APIs are manufactured by pharmaceutical companies and can be formulated into different dosage forms, including tablets, capsules, or liquid preparations.
It's essential to note that the use of hypnotics should be carefully monitored, as prolonged or excessive use may lead to dependence, tolerance, or adverse effects. Therefore, consultation with a healthcare professional is necessary to ensure safe and appropriate use of hypnotics for optimal sleep management.
Chloral hydrate API manufacturers & distributors
Compare qualified Chloral hydrate API suppliers worldwide. We currently have 3 companies offering Chloral hydrate API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Chemische Fabrik Berg | Producer | Germany | Germany | CoA, GMP | 20 products |
| Hänseler AG | Distributor | Switzerland | Germany | CoA, GMP | 174 products |
When sending a request, specify which Chloral hydrate API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Chloral hydrate API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Chloral hydrate API
Sourcing
What matters most when sourcing GMP-grade Chloral hydrate?
Key considerations include confirming full GMP compliance and verifying that the supplier meets US and Canadian regulatory requirements. Given the fragmented market of packagers and generic manufacturers, qualification of the supplier’s quality systems and supply chain is essential. Ensuring consistent quality and traceability is especially important due to the absence of an originator and the broad range of competing sources.
Which documents are typically required when sourcing Chloral hydrate API?
Request the core API documentation set: GMP (3 companies), CoA (3 companies), MSDS (1 company), BSE/TSE (1 company), ISO9001 (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Chloral hydrate API?
Known or reported manufacturers for Chloral hydrate: Caesar & Loretz GmbH (CAELO), Hänseler AG. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Chloral hydrate API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Chloral hydrate manufacturers?
Audit reports may be requested for Chloral hydrate: 1 GMP audit report available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Chloral hydrate API on Pharmaoffer?
Reported supplier count for Chloral hydrate: 3 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Chloral hydrate API?
Production countries reported for Chloral hydrate: Germany (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Chloral hydrate usually hold?
Common certifications for Chloral hydrate suppliers: GMP (3 companies), CoA (3 companies), MSDS (1 company), BSE/TSE (1 company), ISO9001 (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Chloral hydrate (CAS 302-17-0) used for?
Chloral hydrate is used as a sedative–hypnotic for short‑term management of insomnia and for procedural sedation requiring controlled depression of consciousness. It is employed in settings such as sleep initiation or preoperative sedation, with use restricted due to its narrow therapeutic index and risk of respiratory depression. In research settings, it may also serve as an anesthetic agent in animals.
Which therapeutic class does Chloral hydrate fall into?
Chloral hydrate belongs to the following therapeutic categories: Alcohols, Central Nervous System Agents, Central Nervous System Depressants, Drugs that are Mainly Renally Excreted, Ethylene Glycols. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Chloral hydrate mainly prescribed for?
The primary indications for Chloral hydrate: Mainly used as a hypnotic in the treatment of insomnia, However, it is only effective as a hypnotic for short-term use, May be used as a routine sedative preoperatively to decrease anxiety and cause sedation and/or sleep with respiration depression or cough reflex. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
What should someone know about the safety or toxicity profile of Chloral hydrate?
Chloral hydrate has a narrow therapeutic index, and adverse effects are primarily related to dose‑dependent central nervous system and respiratory depression. Additional safety concerns include paradoxical agitation, cardiac arrhythmias, gastrointestinal irritation, and potential hepatic or renal toxicity with excessive or prolonged exposure. It crosses the placenta and enters breast milk, and accumulation of metabolites can occur with repeated dosing. Concomitant use with other CNS depressants or agents affecting alcohol dehydrogenase can increase toxicity risk, and overdose may produce profound CNS depression requiring supportive care.
What are important formulation and handling considerations for Chloral hydrate as an API?
Chloral hydrate is highly water‑soluble and is typically formulated as simple aqueous oral solutions or syrups, but its hygroscopic nature requires controlled handling to limit moisture uptake. Exposure to heat and humidity should be minimized to maintain hydrate integrity and reduce decomposition. Alcohol‑containing excipients should be avoided because of potential reactivity. Careful control of storage conditions helps preserve stability during manufacturing and use.
Is Chloral hydrate a small molecule?
Chloral hydrate is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Chloral hydrate?
Oral Chloral hydrate is sensitive to heat and moisture, which can promote decomposition and affect maintenance of the hydrate form. Because the solid is hygroscopic, handling and storage should limit humidity exposure. Aqueous solutions and syrups should avoid alcohol‑containing excipients to prevent undesirable reactions. Formulations typically use simple aqueous vehicles while controlling these conditions to preserve stability.
Regulatory
Where is Chloral hydrate approved or in use globally?
Chloral hydrate is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Chloral hydrate procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Chloral hydrate. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Chloral hydrate included in the PRO Data Insights coverage?
PRO Data Insights coverage for Chloral hydrate: 348 verified transactions across 75 suppliers and 60 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Chloral hydrate?
Market report availability for Chloral hydrate: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
