Details | Specifications |
|---|---|
CAS Number |
163451-81-8 |
Molecular Formula |
C12H9F3N2O2 |
Molecular Weight |
270.2 |
Synonyms |
(Z)-2-cyano-N-(4-(trifluoromethyl)phenyl)-3-hydroxybut-2-enamide |
Chemical Name |
(Z)-2-cyano-N-(4-(trifluoromethyl)phenyl)-3-hydroxybut-2-enamide |
Grade |
API (EP/USP) |
Polymorph |
NA |
GTI and NI |
Available |
DMF Availability |
Available |
Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*Â
Disclaimer:Â
The information provided on this webpage is based on the best available knowledge at the time of publication; however, accuracy and completeness are not guaranteed. Product specifications may change without notice. It is the responsibility of the purchaser or user to verify suitability and compliance. This product is intended for research use only and is not approved for human consumption.
Terifluonamide, identified by its IUPAC name (Z)-2-cyano-N-(4-(trifluoromethyl)phenyl)-3-hydroxybut-2-enamide and CAS number 163451-81-8, represents a critical active pharmaceutical ingredient (API) in modern therapeutics. This molecule is characterized by its distinctive cyano-enamide core and a trifluoromethylphenyl substituent, contributing to its unique pharmacological profile. As an API, Terifluonamide functions as an immunomodulator, primarily through the reversible inhibition of dihydroorotate dehydrogenase (DHODH), a crucial mitochondrial enzyme involved in the de novo pyrimidine synthesis pathway. This specific mechanism of action disrupts the proliferation of rapidly dividing cells, particularly activated lymphocytes, without causing generalized immunosuppression, making it a highly targeted therapeutic agent. The strategic importance of high-quality Terifluonamide for pharmaceutical manufacturers globally cannot be overstated, as it forms the foundation for developing and producing essential drug products. Shilpa Pharma, a globally recognized GMP-certified manufacturer headquartered in India, is exceptionally positioned to supply Terifluonamide API, meeting stringent pharmacopoeial standards such as the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP). Our manufacturing processes are meticulously designed to ensure the highest purity and consistent quality, making our Terifluonamide API suitable for pharmaceutical applications in highly regulated markets including North America and Europe. This commitment to excellence, combined with our competitive operational efficiencies, ensures a reliable and compliant supply chain for our global clientele seeking Terifluonamide with CAS number 163451-81-8.
The industrial and pharmaceutical formulation applications of Terifluonamide API are primarily centered on its incorporation into finished drug products, predominantly in oral solid dosage forms such as tablets and capsules. Its physicochemical properties, including solubility characteristics, are carefully considered during formulation development. Terifluonamide is generally sparingly soluble in water, necessitating specific formulation strategies to optimize bioavailability, such as micronization to increase surface area or the use of solid dispersion technologies. Formulation scientists also evaluate its compatibility with various pharmaceutical excipients, ensuring stability and preventing undesirable interactions throughout the product’s shelf life. Physical attributes such as particle size distribution, bulk density, and flowability are critical for efficient processing, especially in high-speed tablet compression or capsule filling operations. Shilpa Pharma offers Terifluonamide with controlled particle size specifications to facilitate optimal processing characteristics. Furthermore, its suitability for modified-release or combination products is often explored, depending on specific therapeutic requirements. As a comprehensive CDMO, Shilpa Pharma extends beyond mere API supply by supporting clients through the entire product development lifecycle. Our expertise encompasses pre-formulation studies, formulation development, analytical method validation, process scale-up from pilot to commercial batches, and seamless technology transfer, ensuring that the Terifluonamide API is optimally integrated into the client’s final drug product design and manufacturing process.
Ensuring the industrial and regulatory safety of Terifluonamide API is paramount throughout its manufacturing, storage, and handling. Recommended storage conditions typically involve maintaining the material in a tightly sealed container at controlled room temperature, generally between 15°C and 30°C, protected from light and excessive humidity. Primary packaging requirements often include hermetically sealed, double-bagged polyethylene liners within high-density polyethylene (HDPE) drums or fiber drums to preserve product purity and prevent contamination or degradation. The shelf life and retest period for Terifluonamide are established through comprehensive stability studies conducted under ICH-compliant conditions, with detailed data provided in the Certificate of Analysis (CoA). Personnel handling guidelines emphasize the use of appropriate personal protective equipment (PPE), including chemical-resistant gloves, eye protection, and respiratory protection (e.g., N95 respirators) in areas with potential for airborne dust. Adequate local exhaust ventilation and dust containment measures are essential to minimize occupational exposure. Known incompatibilities or stability-sensitive conditions for Terifluonamide include strong oxidizing agents, strong acids, and strong bases, which can compromise its chemical integrity. Shilpa Pharma ensures compliance with global regulatory classifications such as REACH for exports to the European Union and rigorously adheres to ICH Q3D guidelines for elemental impurities, providing comprehensive impurity profiling and residual solvent analysis. Our quality documentation package includes a detailed Certificate of Analysis, Certificate of Conformance, and a comprehensive Safety Data Sheet (SDS) to guide safe handling and regulatory compliance for industrial manufacturing personnel.
The pricing structure for pharmaceutical APIs like Terifluonamide is influenced by a multifaceted array of commercial and procurement factors. Key determinants include the required purity specification, the batch size ordered, the availability of comprehensive regulatory documentation such as a US-DMF or CEP/EDMF, the origin and integrity of the supply chain, prevailing raw material costs, and global currency exchange rates. Shilpa Pharma, as a GMP-certified manufacturer based in India, offers a highly competitive pricing model without compromising on the uncompromising quality demanded by the pharmaceutical industry. This cost-effectiveness stems from our vertically integrated manufacturing operations, which provide greater control over the entire production process, from key intermediates to the final API, thereby optimizing efficiency and reducing overall production costs. Sourcing from a vertically integrated manufacturer like Shilpa Pharma offers a significant advantage over trading intermediaries, ensuring consistent product quality, enhanced supply chain security, and greater transparency. We accommodate all order sizes, from small research quantities essential for early-stage development to large commercial volumes, offering flexible minimum order quantities (MOQs) to meet diverse client needs. Typical lead times are communicated transparently and depend on batch size, current production schedules, and shipping logistics. Furthermore, Shilpa Pharma encourages long-term supply agreements, which provide our clients with significant benefits, including predictable pricing, guaranteed supply, and enhanced supply chain stability, facilitating better inventory management and production planning.
Pharmaceutical manufacturers, generic drug companies, CDMOs, and research organizations worldwide consistently choose Shilpa Pharma for their Terifluonamide API requirements due to our unwavering commitment to quality, regulatory excellence, and comprehensive client support. Our state-of-the-art, GMP-certified manufacturing infrastructure in India adheres to the highest international standards, ensuring that every batch of Terifluonamide API is produced under meticulously controlled conditions, guaranteeing purity and consistency. Shilpa Pharma provides robust regulatory dossier capabilities, including readily available US-DMFs, CEP/EDMFs, and Certificates of Pharmaceutical Product (COPPs), which significantly expedite our clients’ drug product registration processes across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa. Our in-house analytical capabilities are extensive, featuring advanced instrumentation for HPLC, GC, Karl Fischer, ICP-MS for elemental impurities, and particle size analysis, ensuring thorough impurity profiling and adherence to stringent specifications. Beyond API supply, our integrated CDMO services offer end-to-end support, from custom synthesis of complex intermediates to process development, scale-up, and seamless technology transfer for Terifluonamide and other specialty chemicals. With decades of worldwide export experience, we possess a deep understanding of international logistics and regulatory nuances, ensuring timely and compliant delivery. Clients benefit from dedicated technical support, addressing formulation queries and providing expert guidance. Our supply chain is fully auditable, offering complete transparency and traceability from raw material sourcing to final product delivery, instilling confidence and security in every transaction. The procurement process with Shilpa Pharma is designed to be straightforward and efficient, from initial inquiry to final delivery, making us a trusted partner for critical API sourcing.
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
