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Views: 0 Author: Site Editor Publish Time: 2025-03-19 Origin: Site
In the intricate world of pharmaceutical intermediates, CAS 4271-96-9—known as 1,2-Dimethyl-1,4,5,6-tetrahydropyrimidine (DMTHP)—stands out as a vital compound with significant applications in drug synthesis. As EASTFINE, a B2B pharmaceutical intermediates factory with over 30 years of experience specializing in exporting, we understand the importance of supplying high-quality intermediates like DMTHP to meet the demands of global pharmaceutical manufacturers. This comprehensive guide explores the compound’s chemistry, production, applications, regulatory landscape, market trends, and future potential, providing an in-depth resource for businesses seeking reliable intermediates.
CAS 4271-96-9 is a heterocyclic organic compound that plays a pivotal role in pharmaceutical synthesis. Its unique structure and reactivity make it a sought-after intermediate in the production of active pharmaceutical ingredients (APIs).
1,2-Dimethyl-1,4,5,6-tetrahydropyrimidine has the molecular formula C6H12N2 and a molecular weight of 112.17 g/mol. Structurally, it features a six-membered pyrimidine ring with two nitrogen atoms at positions 1 and 3, partially saturated (tetrahydropyrimidine), and substituted with methyl groups at positions 1 and 2. This configuration distinguishes it from fully aromatic pyrimidines, offering greater flexibility in chemical reactions.
DMTHP is typically a colorless to pale yellow liquid with a boiling point of approximately 170-175°C at standard pressure. It exhibits solubility in organic solvents like ethanol, acetone, and chloroform, but limited solubility in water. Its density is around 0.95 g/cm³, and it has a mild amine-like odor, typical of nitrogen-containing heterocycles.
In pharmaceutical manufacturing, intermediates like CAS 4271-96-9 bridge the gap between basic raw materials and complex APIs. DMTHP’s heterocyclic nature and reactive sites make it an ideal precursor for synthesizing compounds with biological activity, particularly in the anthelmintic drug category.
The primary utility of CAS 4271-96-9 lies in its role as a building block for APIs, with a strong foothold in antiparasitic drug production. Its versatility also hints at broader potential.
DMTHP is a critical intermediate in the synthesis of anthelmintic drugs, which combat parasitic worm infections in humans and animals.
Beyond anthelmintics, DMTHP’s pyrimidine scaffold suggests potential in other therapeutic areas. Researchers are exploring tetrahydropyrimidine derivatives for antimicrobial, antiviral, or even neurological applications, where heterocyclic compounds often excel. For a B2B supplier, this opens doors to custom synthesis projects tailored to innovative drug pipelines.
Producing CAS 4271-96-9 is a sophisticated process requiring expertise in heterocyclic chemistry and industrial-scale optimization—hallmarks of a top-tier pharmaceutical intermediates factory like EASTFINE.
The production of DMTHP typically involves a multi-step synthesis starting with readily available precursors. A common route includes:
Ring Formation: Reaction of 1,3-diaminopropane with a carbonyl compound (e.g., acetaldehyde) to form the pyrimidine ring via cyclization.
Methylation: Introduction of methyl groups using agents like dimethyl sulfate or formaldehyde with a reducing agent (e.g., formic acid).
Partial Hydrogenation: Controlled reduction of the pyrimidine ring to achieve the tetrahydropyrimidine structure, often using a metal catalyst like palladium on carbon.
The process requires precise control of temperature (typically 50-100°C), pressure, and pH to optimize yield and minimize byproducts. Acidic or basic catalysts may be employed, depending on the methylation step.
Factories use stainless steel reactors, distillation columns, and filtration systems to produce DMTHP at scale. High-pressure hydrogenation units are essential for the reduction step, while analytical tools like Gas Chromatography-Mass Spectrometry (GC-MS) ensure product purity.
Key challenges include avoiding over-reduction (which could fully saturate the ring) and managing side reactions that produce unwanted isomers. For export-oriented businesses, achieving batch-to-batch consistency is paramount, requiring robust quality control systems.
Pharmaceutical-grade DMTHP typically requires ≥98% purity. Impurities like unreacted diamines or over-methylated derivatives must be minimized, often through recrystallization or advanced distillation techniques.
Exporting CAS 4271-96-9 demands compliance with international regulations and rigorous safety protocols, reflecting its pharmaceutical significance.
In regulated markets, intermediates must adhere to Good Manufacturing Practices (GMP) as outlined by the ICH Q7 guidelines. For APIs like pyrantel, suppliers may need to file Drug Master Files (DMFs) detailing DMTHP’s production and quality. As Pyrantel Impurity D, it falls under pharmacopeial standards (e.g., USP, EP), with specific limits on its presence in finished drugs.
Exporting requires a Safety Data Sheet (SDS), Certificate of Analysis (CoA), and compliance with the Harmonized System (HS) code 2933.39 (heterocyclic compounds with nitrogen). For hazardous shipments, UN packaging and labeling are mandatory.
DMTHP is flammable (flash point ~60°C) and may cause skin or respiratory irritation. Production facilities must implement safety measures like explosion-proof equipment, proper ventilation, and personal protective gear. Spills or leaks require immediate containment to prevent environmental harm.
Waste streams from DMTHP synthesis—such as excess solvents or catalysts—must be treated per regulations like REACH (Europe) or TSCA (U.S.). Green chemistry approaches, like solvent recycling, are increasingly adopted to reduce ecological footprints.
As a B2B exporter, understanding the global market for CAS 4271-96-9 is essential for strategic positioning and meeting client needs.
Demand for DMTHP is propelled by the global need for anthelmintics. Human parasitic infections remain prevalent in tropical regions, while veterinary use grows in livestock-heavy markets like Brazil, India, and China. The compound’s role in R&D for new drugs further boosts its market potential.
India, a hub for generic drug production, is a major importer of intermediates like DMTHP. Europe and North America, with stringent quality requirements, offer high-value opportunities for GMP-certified suppliers. Emerging markets in Africa and Southeast Asia present untapped growth potential.
China dominates intermediates production with cost advantages, but quality-focused exporters can compete by emphasizing purity, regulatory compliance, and customer service. Differentiation through custom synthesis or faster delivery times is a key strategy.
As a flammable liquid, DMTHP requires specialized transport under Dangerous Goods regulations (e.g., IATA Class 3). Temperature-controlled containers ensure stability during long-haul exports, critical for maintaining quality to distant markets.
At EASTFINE, we bring over 30 years of experience in manufacturing pharmaceutical intermediates to the table, making us a trusted partner for sourcing CAS 4271-96-9. Our expertise, reliability, and global reach set us apart in the B2B landscape.
With more than three decades in the industry, EASTFINE has honed its skills in fine chemistry, ensuring top-tier production of DMTHP. Our experienced team optimizes synthesis processes to deliver consistent, high-purity intermediates that meet your exact specifications.
Whether you need a 10 kg trial batch or metric tons for commercial production, EASTFINE scales seamlessly to your requirements. Our R&D capabilities also enable us to customize DMTHP or develop related intermediates, supporting your innovative drug pipelines.
As an export-focused company, EASTFINE has a proven track record of delivering intermediates worldwide—from North America to Asia. Our expertise in international shipping, customs compliance, and regulatory documentation ensures your DMTHP arrives on time and meets local standards.
Quality is at the core of EASTFINE’s operations. With certified facilities, full traceability, we guarantee pharmaceutical-grade DMTHP (≥98% purity). Our commitment to excellence has earned us trust across the globe for over 30 years.
Looking ahead, CAS 4271-96-9 holds promise as a cornerstone intermediate, shaped by industry trends and innovation.
Green chemistry could transform DMTHP production, using bio-based precursors or catalytic processes to reduce waste. This aligns with client demands for sustainable supply chains.
Automation and AI-driven process optimization may enhance efficiency, lowering costs and improving yields. Continuous flow reactors, for instance, could streamline synthesis for exporters.
Research into pyrimidine derivatives may unlock new applications for DMTHP, such as in antiviral agents or cancer therapies. B2B suppliers investing in R&D can lead this evolution.
Post-pandemic, supply chain robustness is critical. Exporters of CAS 4271-96-9 can strengthen their role by diversifying sourcing and ensuring uninterrupted supply, even in crises.
CAS 4271-96-9, or 1,2-Dimethyl-1,4,5,6-tetrahydropyrimidine, is more than just a chemical—it’s a linchpin in pharmaceutical innovation. From its pivotal role in anthelmintic drugs like pyrantel and morantel to its potential in emerging therapies, DMTHP exemplifies the value of intermediates in modern medicine. At EASTFINE, with over 30 years of experience as a B2B pharmaceutical intermediates factory specializing in exporting, we’re proud to deliver this compound with the quality, consistency, and global reach our clients deserve. Whether you’re scaling up API production or exploring new drug candidates, CAS 4271-96-9 is a compound to watch—and EASTFINE is your partner to supply it.
