Fezolinetant is a selective neurokinin 3 receptor antagonist supplied as a high-purity active pharmaceutical ingredient. The compound targets hypothalamic KNDy neurons to modulate neurokinin pathway activity. Engineered for advanced oral solid dosage manufacturing, the material provides consistent physicochemical properties and batch reproducibility for pharmaceutical development pipelines.
Product Information
|
Attribute |
Details |
|
International Nonproprietary Name (INN) |
Fezolinetant |
|
Development Code |
ESN-364 |
|
CAS Number |
1629229-37-3 (Free Base) |
|
Chemical Name |
(R)-(4-fluorophenyl)(8-methyl-3-(3-methyl-1,2,4-thiadiazol-5-yl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)methanone |
|
Therapeutic Category |
Neurokinin 3 Receptor Antagonist |
|
Storage Condition |
Store in tightly closed containers at 2°C to 8°C under dry conditions |
Quality & Specification
Appearance: White to off-white crystalline powder
Identification: Retention time and spectrum match reference standard via HPLC and FTIR
Assay (Purity): Greater than or equal to 99.0% on an anhydrous basis
Individual Specified Impurity: Less than or equal to 0.10%
Total Impurities: Less than or equal to 0.50%
Water Content: Less than or equal to 0.5% by Karl Fischer titration
Residue on Ignition: Less than or equal to 0.1%
Heavy Metals: Less than 10 ppm via ICP-MS
Residual Solvents: Complies with ICH guidelines for organic volatiles
Manufacturing & Supply
Stereochemical Control
Produced via stereoselective synthesis to maintain the required (R)-enantiomer configuration.
Processing Environment
Micronization and isolation executed within ISO Class 8 cleanroom facilities to prevent cross-contamination.
Supply Scale
Available from gram quantities for laboratory evaluation to multi-kilogram commercial production batches.
Documentation
Certificate of Analysis: Issued with every batch confirming complete physical and chemical test results.
Regulatory Support: Complete chemistry, manufacturing, and controls data packages available to support drug master file submissions.
Stability Data: Long-term and accelerated testing packages available for shelf-life verification.
Safety Data Sheet: Comprehensive handling, storage, and toxicological documentation supplied in accordance with global standards.
Packaging
|
Primary Container |
Double-layer medical-grade low-density polyethylene bags, vacuum-sealed. |
|
Secondary Barrier |
Moisture-resistant aluminum foil barrier bag protecting against light and atmospheric humidity. |
|
Outer Protection |
Rigid fiber drum fitted with tamper-evident seals; standard net weight options of 1 kg, 5 kg, and 25 kg. |
Pharmaceutical Application
Vasomotor Symptom Formulations: Functions as the active ingredient in solid oral dosage forms developed to alleviate menopausal hot flashes without hormonal pathways.
Neuroendocrine Research: Applied as a primary test compound in pharmacological investigations targeting neurokinin receptor mechanisms.
Controlled-Release Delivery: Incorporated into matrix tablet research to optimize pharmacokinetic absorption profiles and maintain steady plasma concentrations.
FAQ
Q: What is the stereochemical purity of the material?
A: The product is supplied as the (R)-enantiomer free base with verified chiral purity meeting pharmaceutical standards.
Q: What stability data packages are accessible?
A: Both long-term storage data at 25°C and accelerated stability packages at 40°C are available upon request.
Q: Are analytical reference standards provided?
A: Characterized reference standards can be supplied to support internal method validation and HPLC testing.
Q: What is the established retest period?
A: The standard retest period is 24 months when stored unopened under recommended refrigeration conditions.
Q: Can particle size distribution be customized?
A: Mechanical micronization is available to adjust particle size parameters according to specific formulation requirements.
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