Fezolinetant Powder CAS 1629229-37-3｜High Purity ≥99% for Menopausal Hot Flushes Research
Core Benefits:
● Non-hormonal API for hot flashes and night sweats drug R&D
● High chiral purity, low impurities and stable batch consistency
● GMP-compliant with full set of standard test documents
● Ideal for global formulation development and scientific research procurement
Product Overview
Fezolinetant Powder for research-grade, preclinical, and clinical oral formulation development (CAS: 1627710-34-8) is a targeted NK3 receptor antagonist API widely used in non-hormonal menopause vasomotor symptom R&D. As a selective neurokinin 3 (NK3) receptor antagonist, it has a stable chemical structure, single chiral configuration, and physicochemical properties compliant with oral formulation development standards.
Fezolinetant Powder serves global pharmaceutical companies, CROs, academic laboratories, and cross-border pharmaceutical trade. With mature chemical synthesis, chiral separation, and recrystallization processes, it meets ICH API quality standards. The powder can be used in early-stage preclinical and pilot studies, oral formulation screening, pharmacology, toxicology, and pharmacokinetics research, providing a stable and traceable research-grade raw material for non-hormonal menopause vasomotor symptom drug development.
COA
| Item | Specification | Result | |
| Appearance | White or off-white powder. | White powder | |
| Solubility | Report | Soluble in acetonitrile,very slightly soluble in water. | |
| NMR | The'HNMR and¹³C NMR spectra should be concordant with the structure | The'HNMR and¹³C NMR spectra are concordant with the structure. | |
| IR | The IR spectrum should be concordant with the structure. | The IR spectrum is concordant with the structure. | |
| MS | The MS spectrum should be concordant with the structure. | The MS spectrum is concordant with the structure. | |
| Any other individual impurity≤0.10% | 0.05% | ||
| Total impurities≤1.0% | 0.09% | ||
| Enantiomer | ≤0.15% | Not detected | |
| Residue on Ignition | ≤0.1%. | Not detected | |
| Water | ≤0.5% | 0.31% | |
| Crystal Form | The XRD spectrum of sample should correspond to that of crystal Form. | The XRD spectrum of sample corresponds to that of crystal Form | |
| Tapped Density | Report | 0.66 g/mL | |
| Microbial Limits | Report | TAMC<100 cfu/g | |
| TYMC<10 cfu/g | |||
| Pseudomonas aeruginosa:absent in 1g Staphylococcus aureus:absent in 1g |
|||
| Salmonella spp:absent in 1g | |||
| Escherichia coli:absent in 1g | |||
| Assay | 98.0%-102.0% | 99.60% | |
| Conclusion | The product conforms to the specification. | ||
Mechanism of Action
The core mechanism of Fezolinetant Powder is selective antagonism of NK3 receptors. During menopause, estrogen decline disrupts hypothalamic-pituitary-ovarian axis regulation, causing excessive neurokinin B secretion and overactivation of central NK3 receptors. This sensitizes the thermoregulatory center, triggering hot flashes, night sweats, and palpitations. Fezolinetant Powder for research-grade oral formulation and preclinical R&D binds specifically to NK3 receptors, blocking neurokinin B signaling, stabilizing thermoregulatory sensitivity, and improving menopause vasomotor symptoms. Unlike hormone therapies, it acts on neural signaling pathways rather than supplementing hormones, providing a novel non-hormonal raw material for drug development.
Product Applications
Fezolinetant Powder for research-grade, non-hormonal oral formulation development can be used for:
￭ Preclinical and pilot-scale development of non-hormonal oral formulations for menopause vasomotor symptoms.
￭ Toxicology, pharmacokinetics, and pharmacology research on NK3 receptor pathways and female endocrine health.
￭ Research and development of innovative non-hormonal drug candidates for menopause.
￭ Pharmaceutical intermediate for cross-border trade, supporting regulatory-compliant global R&D projects.
￭ Academic research on neural receptor pharmacology and menopause pathology mechanisms.
Benifits of Fezolinetant Powder
￭ Potent Anti-Vasomotor Effect: Blocks abnormal neurokinin B signaling, reducing hypersensitivity in the hypothalamic thermoregulatory center, lowering hot flash and night sweat frequency, and supporting effective non-hormonal menopause symptom management.
￭ High Target Specificity: Acts precisely on central nervous system targets, minimizing off-target CNS adverse effects.
￭ Stable Bioavailability: Optimized molecular structure enhances intestinal absorption, reduces plasma concentration fluctuations, ensures consistent pharmacological effects, and lowers experimental or formulation development risks.
￭ Chemical and Physical Stability: Resistant to hydrolysis and oxidation, suitable for long-term research and scalable production.
Core Advantages
￭ Mature Target Mechanism: NK3 receptor antagonism is clinically validated and aligns with global trends in non-hormonal menopause therapy.
￭ Stable Chiral and Purity Profile: Standardized chiral separation ensures low batch-to-batch variability.
￭ Flexible Supply: Multiple packaging options, supporting sample, small, and mid-scale orders.
￭ Mature Cross-Border Delivery: Full export compliance for smooth international shipping.
￭ Reliable Long-Term Supply: Scalable production ensures sufficient stock, avoiding disruption in R&D timelines.
Quality Assurance
￭ Full-Process GMP Control: From raw materials, synthesis, chiral separation, to final packaging, each batch undergoes HPLC, chiral purity, moisture, impurity, and appearance testing.
￭ Strict Impurity Management: Organic impurities, residual solvents, heavy metals, and isomers comply with ICH limits.
￭ Complete Batch Traceability: Each batch is uniquely numbered, traceable across production, testing, and shipping.
￭ Professional Storage: Low temperature, light-protected, moisture-proof storage maintains physicochemical properties.
￭ After-Sales Support: Raw material application consulting, specification interpretation, and process guidance.
FAQ
Q1: What is Fezolinetant Powder?
A: A selective NK3 receptor antagonist for menopause vasomotor symptoms such as hot flashes and night sweats.
Q2: How does it work?
A: Blocks NK3 receptors on hypothalamic GnRH neurons to regulate luteinizing hormone secretion, mitigating vasomotor symptoms caused by estrogen fluctuations.
Q3: Can Fezolinetant Powder be directly used for commercial formulations?
A: It is a research-grade API suitable for early-stage trials and pharmacology studies. Commercial use requires regulatory-compliant API and documentation.
Q4: Can purity or chiral specification be customized?
A: Yes, specifications can be tailored to project needs, supporting differentiated formulation development.
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Fezolinetant Powder for research-grade, non-hormonal oral formulation development supports stable physicochemical properties, rigorous quality control, complete documentation, and flexible supply, enabling efficient global menopause vasomotor symptom R&D. Contact us for pricing, sample requests, COA files, or custom supply solutions.Available for global shipment with competitive pricing, GMP certification and traceable batches for research labs worldwide.
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