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Zavegepant Hydrochloride (CAS 1414976-20-7) is a highly selective calcitonin gene-related peptide (CGRP) receptor antagonist (active pharmaceutical ingredient, API). It is synthesized from 2,6-dimethylaniline and other raw materials through a multi-step process involving condensation, asymmetric hydrogenation, and chiral construction.
As the world's first nasal spray API for the treatment of migraine, it can rapidly relieve headache and associated symptoms. The core of its manufacturing process lies in chiral control; the product exhibits excellent stability, and market demand continues to grow.
Technical Specifications
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Product Name |
Zavegepant Hydrochloride |
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Synonyms |
Zavegepant HCl API, Zavegepant HCL |
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Characteristics |
A white or off-white powder. |
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CAS Number |
1414976-20-7 |
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Assay |
≥99.0% (HPLC, Subject to the COA) |
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Formula |
C36H47CIN8O3 |
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Package |
Standard Packaging: 1kg/Aluminum Foil Bag, 5kg/Aluminum Drum, 25kg/Fiber Drum (with double polyethylene liners)Custom Packaging: Available upon request, strictly sealed under inert gas to prevent moisture and oxidation |
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Storage |
Short-term / Routine storage: Refrigerate at 2–8 °C, sealed, dry, light‑protected, under inert gas protection. Long-term / Inventory storage: Freeze at −20 °C, stable for 3 years. Solution storage: Store at −80 °C for up to 1 year or at −20 °C for approximately 1 month; avoid repeated freeze-thaw cycles. |
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Structure |
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Our Zavegepant HCl powder is produced with Zavegepant HCl powder featuring precise control over batch-to-batch consistency. With superior quality uniformity and batch controllability, it is perfectly suitable for the whole process scenarios such as nasal spray formulation development, pharmacodynamic studies, and clinical-grade applications.
Product Features
With its unique CGRP receptor antagonistic mechanism, CAS 1414976-20-7 precisely targets the acute treatment of migraine, providing a highly effective solution for unmet clinical needs. The innovative nature of its nasal spray delivery route not only enables faster onset of action and more convenient administration, but also opens up a differentiated competitive landscape for formulation development, helping customers develop migraine treatment products with greater clinical advantages.
As professional China manufacturers of Zavegepant Hydrochloride (CAS 1414976-20-7), we offer products with excellent physicochemical properties, exceptional water solubility and solid-state stability.They not only satisfy the stringent requirements of nasal spray formulations for dissolution, absorption and stability, but also provide ample room for the development of subsequent dosage forms such as oral preparations.With high purity and controllable impurities, our products can significantly reduce the difficulty of formulation screening, minimize formulation rework and stability risks caused by raw material issues, and greatly shorten the formulation R&D cycle.
Relying on our mature large‑scale production system and based on stable and repeatable processes, we achieve high uniformity in batch‑to‑batch quality, avoiding quality fluctuations caused by inconsistencies between laboratory-scale data and commercial production.Our stable supply capacity and traceable production system effectively support customers' full‑cycle raw material needs from early research and clinical trials to commercial launch, while mitigating the risk of supply chain disruptions.
We provide comprehensive and systematic quality research documentation supporting our Zavegepant HCL API (active pharmaceutical ingredient), covering key testing items including assay, related substances, residual solvents, moisture content and elemental impurities. With standardized data and complete structural information, these documents can directly support the preparation of pharmaceutical dossiers as well as domestic and overseas registration filings.The product is manufactured in strict accordance with GMP principles, and its impurity control meets the requirements of ICH guidelines and major pharmacopoeias.
Full-Cycle Quality Control & Consistent Quality
Quality is the core competitiveness of Zavegepant HCL API. We have established a full-process quality control system covering from raw materials to finished product delivery, supporting pharmaceutical R&D and registration applications with stable and reliable quality.
Synthetic Process Control
CAS 1414976-20-7 is manufactured via an optimized directed synthetic route with closed-loop monitoring of reaction parameters. Feeding ratio, reaction temperature range and conversion time are precisely controlled to suppress the formation of process impurities and isomers at the production stage, ensuring stable and controllable intermediate quality.
Refining and Purification
Zavegepant Hydrochloride undergoes multi-stage recrystallization, precision filtration, vacuum drying and other purification steps to effectively remove residual impurities and solvents. Its crystal form and particle size distribution are strictly controlled, ensuring that product purity and physicochemical properties fully comply with pharmacopoeial standards and ICH guidelines.
Testing and Release Management
A complete Certificate of Analysis (COA) is issued for each batch of Zavegepant Hydrochloride (CAS 1414976-20-7), covering all indicators including related substances, assay, residual solvents, moisture, melting point and appearance. Testing data are fully traceable with consistent batch-to-batch performance, meeting the stringent quality control standards for pharmaceutical R&D, pilot production and registration filings.
Product Stability and Batch Consistency: We have established a long-term stability monitoring program and real-time batch comparison mechanism. Scientific accelerated testing, long-term storage monitoring, and stability studies under light, humidity and heat conditions fully verify the quality stability of Zavegepant HCL under routine storage and transportation conditions, effectively reducing degradation risks and ensuring no significant fluctuations in product indicators throughout its shelf life.
Application Scenarios
The core applications of Zavegepant HCl focus on R&D, production and scientific research related to the acute treatment of migraine, with specific scenarios as follows:
Formulation Development:
It is mainly used for formulation screening, process optimization and compatibility research of novel dosage forms such as nasal sprays and oral preparations. It focuses on supporting the stability investigation and bioavailability optimization of fast-onset, mucosal absorption preparations, and provides key raw material support for the development of differentiated migraine therapeutic drugs with Customized Zavegepant HCl API.
Registration & Preclinical Research
It can be used in pharmacological and efficacy evaluation, pharmacokinetic studies and safety assessment tests, meeting the demand of pharmaceutical companies for high-quality reference standards and test APIs in IND filings and clinical research stages, facilitating the completion of research dossiers and smooth registration progress.
Commercial Production:
Relying on stable large-scale production capacity, we provide pharmaceutical enterprises with Zavegepant Hydrochloride made in China that meets pharmaceutical standards. We support pilot-scale verification and commercial large-scale production, ensure continuous and stable supply of multiple batches, and adapt to the long-term production and market supply demands of marketed drugs.
Scientific Research
It is provided to research institutions for cutting-edge academic studies on CGRP receptor mechanisms and migraine treatment strategies, supporting technological advancement in the industry.
Packaging and Transportation
Considering that Zavegepant HCl API is prone to changes in appearance under the influence of temperature, humidity and light, we have developed a customized full-process packaging and transportation protection plan to comprehensively ensure product quality stability from production to delivery.
Precise Temperature & Humidity Control and Traceability
In view of the hygroscopic and temperature-sensitive nature of Zavegepant Hydrochloride, constant-temperature cold-chain transportation is adopted throughout the whole process, equipped with real-time temperature and humidity monitoring devices with automatic over-temperature alarms. Full-process data are recorded and a temperature control report is provided with the shipment. The storage and transportation temperature is strictly controlled at 2–8℃ to prevent fluctuations in temperature and humidity from affecting product purity and stability.
Light Protection and Enhanced Packaging
Considering the photosensitivity of the product, outer packaging uses double-layer light-proof aluminum foil bags plus light-proof transit cases, with food-grade desiccants inside to provide double isolation from light and moisture. Clear warning labels such as "Protect from Light, Moisture , Cold Storage" are marked on the exterior to avoid product degradation caused by light exposure or moisture absorption during transportation and storage, thus maintaining intact quality.
Standardized Storage and Shelf-Life Management
As a China Zavegepant Hydrochloride factory, our storage environment strictly complies with GMP requirements, equipped with constant temperature and humidity warehouses, classified storage and dedicated personnel management, following the first-in first-out principle. We conduct regular stability sampling inspections on inventory products and establish a shelf-life early warning mechanism to remind customers of the stocking cycle in advance, so as to avoid impact on use due to shelf-life expiration and meet the needs of R&D and commercial production.
Compliant Transportation and Carrier Management
We select carriers with GSP certification and pharmaceutical cold-chain transportation qualifications, and verify their cold-chain equipment calibration records and personnel professional credentials. For international transportation, we adapt to the regulatory requirements of destination countries in advance, complete customs declaration, quarantine and UN transport-related documentation to avoid cargo detention risks, ensuring global compliant delivery of products.
Full-Chain Traceability and Emergency Response
We have established a full-chain traceability system covering production, warehousing, transportation and delivery, enabling each batch of Bulk Zavegepant HCl API to be traced back to its raw materials, manufacturing and testing processes. Contingency plans are formulated for abnormalities in transportation and storage, allowing rapid response to issues such as packaging damage and temperature control deviations. Products will be replaced promptly with synchronized testing to minimize risks for our customers.
Our Advantages
Compliant Production Process & Standardized Control
The production of Zavegepant Hydrochloride is fully compliant with GMP standards. Standardized synthesis processes are adopted to strictly control impurities, and dual-certified suppliers are carefully selected for raw material management to ensure batch consistency, which fully meets the requirements of R&D, registration and commercial production.
Precise Impurity Control & Purity Guarantee
We focus on purity and impurity control, adopting high-precision testing equipment to conduct full-process detection in accordance with pharmacopoeial and international standards. The product purity is guaranteed to be ≥99%, and traceable COA and test reports are provided for each batch to meet the requirements of R&D, clinical research and registration.
Storage Guidance & Quality Maintenance
Professional storage guidance and shelf-life recommendations are provided. In light of the product's hygroscopic and photosensitive properties, customized light-proof, moisture-proof and sealed packaging is adopted, with full cold-chain monitoring and shockproof protection during transportation to ensure the intact quality of the product upon delivery.
Compliance Qualification & Global Access Support
We hold complete compliance qualifications and can provide all documents required for registration in various countries, along with a full set of technical documents. We offer 24-hour after-sales response and personalized solutions, and our products are exported to multiple regions, gaining high recognition from global customers.
Efficient Supply Chain & Fast Delivery Guarantee
We have established a mature, stable large-scale production system and a global warehousing network to ensure that our core raw material Zavegepant HCl API in stock, which significantly shortens order response and delivery cycles. A highly efficient end-to-end performance mechanism has been put in place to flexibly meet urgent orders and large-volume procurement demands, ensuring the efficient progress of customer R&D and production projects. Relying on a sound global logistics network, we guarantee fast and safe product delivery to destinations worldwide, helping customers seize market opportunities.
FAQ
If you are already familiar with migraine-related formulations, high-quality Zavegepant HCI API and professional supporting services, and are interested in them, please feel free to contact us for negotiation. We can provide accurate and real-time product quotes, one-on-one technical support, as well as customized cooperation plans from R&D laboratory trials to commercial supply, providing stable and reliable raw material guarantee for the advancement of your projects.
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