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Dichloralphenazone | CAS No: 480-30-8 | GMP-certified suppliers
A medication that provides sedative and analgesic effects for symptomatic relief of tension-type and vascular headaches, including migraines, primarily in combination formulations.
Therapeutic categories
Product Snapshot
- Dichloralphenazone is available as oral gelatin-coated capsules
- It is primarily used as a sedative and muscle relaxant agent
- The compound holds approval status in the US market but is also noted for illicit use
Clinical Overview
As a central nervous system depressant, dichloralphenazone’s pharmacological action is related to its sedative properties, although specific detailed mechanism of action data is not well characterized in the literature. Chloral hydrate, one component, is known for its hypnotic and sedative effects, metabolizing in vivo to trichloroethanol, which modulates GABA receptors. Phenazone, another component, has analgesic and anti-inflammatory properties which contribute to the overall efficacy of the combination products in headache relief.
Dichloralphenazone is classified as a Schedule IV controlled substance in the United States, reflecting its limited clinical usage due to potential for abuse or dependence. Its safety profile mandates caution, especially regarding central nervous system depression, which can be compounded by concomitant use of other sedatives or alcohol. Specific toxicological data for dichloralphenazone itself are limited, but components like chloral hydrate have established risks including respiratory depression and hepatic toxicity at higher doses or prolonged use.
Pharmacokinetic data including absorption, distribution, metabolism, and elimination parameters are insufficiently described in the public domain, limiting detailed ADME characterization. The clinical utility of dichloralphenazone is largely confined to its use as part of multi-ingredient formulations rather than as a standalone agent.
From an API sourcing and quality perspective, procurement should prioritize compliance with applicable regulatory standards for controlled substances. Suppliers must provide evidence of consistent purity, identity (e.g., matching CAS 480-30-8), and absence of significant impurities. The controlled status necessitates robust supply chain controls and documentation to ensure legal and regulatory compliance globally.
Identification & chemistry
| Generic name | Dichloralphenazone |
|---|---|
| Molecule type | Small molecule |
| CAS | 480-30-8 |
| UNII | YYX637R279 |
| DrugBank ID | DB01495 |
Formulation & handling
- Dichloralphenazone is a small molecule intended for oral administration, typically formulated in gelatin-coated capsules.
- Its moderate water solubility (47.4 g/L) supports oral bioavailability but may require attention to excipient compatibility.
- Avoidance of alcohol is advised due to potential interaction, relevant during formulation and patient counseling.
Regulatory status
| Lifecycle | The API has patent protection recently expired in the US, leading to increasing availability of generic products. The market is transitioning from exclusive brand availability to a more competitive, mature phase. |
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| Markets | US |
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Supply Chain
| Supply chain summary | The manufacturing landscape for Dichloralphenazone involves multiple originator companies offering combination branded products primarily in the US market. These branded formulations typically include Isometheptene Mucate, Dichloralphenazone, and Acetaminophen. Patent expirations have allowed for existing generic competition within this segment. |
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Dichloralphenazone is a type of Hypnotics and sedatives
Hypnotics and sedatives belong to the pharmaceutical API category that plays a crucial role in the field of medicine. These compounds are specifically designed to induce sleep, reduce anxiety, and promote relaxation in patients. With their sedative properties, hypnotics and sedatives are commonly prescribed to treat sleep disorders, insomnia, and certain psychiatric conditions.
Pharmaceutical companies produce hypnotics and sedatives as active pharmaceutical ingredients (APIs), which are the key components responsible for the desired therapeutic effects. These APIs are carefully synthesized and formulated to ensure optimal efficacy and safety in patients. Common examples of hypnotics and sedatives include benzodiazepines, barbiturates, and non-benzodiazepine sedative-hypnotics.
The development of hypnotics and sedatives involves rigorous research and testing to ensure their effectiveness and minimize potential side effects. These APIs work by targeting specific receptors in the central nervous system (CNS), such as GABA receptors, which help regulate neuronal activity and promote sedation. By modulating these receptors, hypnotics and sedatives can produce a calming effect, induce sleep, and alleviate symptoms of anxiety and restlessness.
It is important to note that the use of hypnotics and sedatives should be carefully monitored by healthcare professionals, as they can have potential side effects, such as drowsiness, impaired coordination, and dependence. Additionally, these medications may interact with other drugs, necessitating caution and proper dosage adjustments.
In summary, hypnotics and sedatives are a vital category of pharmaceutical APIs used to promote sleep, reduce anxiety, and induce relaxation. Their precise mechanisms of action on the CNS receptors contribute to their therapeutic effects, making them valuable tools in managing sleep disorders and certain psychiatric conditions.
Dichloralphenazone API manufacturers & distributors
Compare qualified Dichloralphenazone API suppliers worldwide. We currently have 1 companies offering Dichloralphenazone API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Chemische Fabrik Berg | Producer | Germany | Germany | CoA, GMP | 20 products |
When sending a request, specify which Dichloralphenazone 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 Dichloralphenazone 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.
