Hydroxycitronellal API Manufacturers & Suppliers
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Hydroxycitronellal | CAS No: 107-75-5 | GMP-certified suppliers
A medication that serves as a standardized chemical allergen for FDA-approved patch testing to aid diagnosis of allergic contact dermatitis in individuals aged six years and older.
Therapeutic categories
Primary indications
- Hydroxycitronellal is approved by the FDA for use within allergenic epicutaneous patch tests which are indicated for use as an aid in the diagnosis of allergic contact dermatitis (ACD) in persons 6 years of age and older
Product Snapshot
- Hydroxycitronellal is formulated as a cutaneous kit designed for epicutaneous patch testing
- It is primarily used as a diagnostic aid for allergic contact dermatitis in patients aged 6 years and older
- This product holds FDA approval for use within the US market and is considered experimentally approved for this indication
Clinical Overview
From a clinical perspective, hydroxycitronellal has regulatory approval for use as a standardized chemical allergen in allergenic epicutaneous patch testing. The US Food and Drug Administration (FDA) specifically authorizes its application in dermatologic testing for allergic contact dermatitis (ACD) in individuals aged six years and older. Patch testing with hydroxycitronellal aids in the identification of sensitization to this compound, enabling diagnostic clarification when allergic contact dermatitis is suspected. Sensitivity to hydroxycitronellal is identified by a clinical patch test, where a localized immune response is observed.
Pharmacodynamic and detailed mechanistic data on hydroxycitronellal are not extensively characterized. It is understood to contribute to cell-mediated immunity through the induction of contact allergens and is associated with an increased histamine release relating to skin hypersensitivity reactions. Its categorization includes classification as a standardized chemical allergen and involvement in immune-mediated dermal responses.
Regarding absorption, distribution, metabolism, and excretion (ADME), specific human pharmacokinetic profiles of hydroxycitronellal are not well documented in the literature. Safety concerns primarily focus on its potential for sensitization and allergenicity rather than systemic toxicity.
For pharmaceutical and cosmetic manufacturers sourcing hydroxycitronellal as an active ingredient or fragrance compound, stringent quality controls are essential. Suppliers should provide material compliant with established purity specifications and regulatory standards, including limits on allergenic potential. Ensuring traceability, batch consistency, and adherence to IFRA and other relevant guidelines is critical to minimize adverse dermatologic events and to maintain regulatory compliance in global markets.
Identification & chemistry
| Generic name | Hydroxycitronellal |
|---|---|
| Molecule type | Small molecule |
| CAS | 107-75-5 |
| UNII | 8SQ0VA4YUR |
| DrugBank ID | DB14187 |
ADME / PK
| Half-life | The mean elimination half-life has been found to be 3.3 h . |
|---|---|
| Metabolism | Studies in rabbits have shown that hydroxycitronellal is converted to two primary metabolites: reduction to the alcohol 7-hydroxycitronellol and oxidation to the carboxylic acid 7-hydroxycitronellylic acid . On average, about 50% of hydroxycitronellal is excreted as 7-hydroxycitronellylic acid which is therefore regarded as the major metabolite . |
| Volume of distribution | Tmax was found to be 2.70 ± 1.36 |
Formulation & handling
- Hydroxycitronellal is a small molecule suitable for cutaneous formulations, not intended for oral or injectable use.
- Its moderate logP and low water solubility suggest consideration of solubilizing agents or appropriate solvents in topical formulations.
- Stability and handling should focus on maintaining integrity during topical application, with no significant food interaction concerns.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) for this product is approaching patent expiry in the US, indicating a transition phase from exclusive market protection toward increased generic competition and wider market availability. |
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| Markets | US |
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Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Hydroxycitronellal includes originator companies that provide branded products predominantly in the US market, exemplified by applications such as the T.R.U.E. Test Thin-Layer Rapid Use Patch Test. Branded products have a limited global presence, primarily centered in the US with minimal or no representation in the EU or other regions. Available patent information suggests existing generic competition is likely, reflecting either expired or near-expiry patents. |
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Hydroxycitronellal is a type of Antimetabolites
Antimetabolites are a prominent category of pharmaceutical active pharmaceutical ingredients (APIs) utilized in the treatment of various diseases, particularly cancer. These compounds are structurally similar to naturally occurring metabolites essential for cellular processes such as DNA and RNA synthesis. By mimicking these metabolites, antimetabolites interfere with the normal functioning of cellular pathways, leading to inhibition of cancer cell growth and proliferation.
One of the widely used antimetabolites is methotrexate, a folic acid antagonist that inhibits the enzyme dihydrofolate reductase, disrupting the production of DNA and RNA. This disruption impedes the growth of rapidly dividing cancer cells. Another common antimetabolite is 5-fluorouracil (5-FU), which inhibits the enzyme thymidylate synthase, thereby interfering with DNA synthesis and inhibiting cancer cell proliferation.
Antimetabolites can be classified into several subcategories based on their mechanism of action and chemical structure. These include purine and pyrimidine analogs, folic acid antagonists, and pyrimidine synthesis inhibitors. Examples of antimetabolites in these subcategories include azathioprine, cytarabine, and gemcitabine.
Despite their effectiveness, antimetabolites can exhibit certain side effects due to their interference with normal cellular processes. These side effects may include gastrointestinal disturbances, myelosuppression (reduced production of blood cells), and hepatotoxicity.
In conclusion, antimetabolites are a vital category of pharmaceutical APIs used in the treatment of various diseases, especially cancer. By mimicking natural metabolites and disrupting crucial cellular processes, these compounds effectively inhibit cancer cell growth and proliferation. However, their usage should be carefully monitored due to potential side effects.
