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CAS No: 202189-76-2 refers to the chemical compound known as 2-[4-[1-(4,4-dimethyl-5H-oxazol-2-yl)-1-methyl-ethyl]phenyl]ethyl 4-methylbenzenesulfonate. It is widely recognized in the pharmaceutical industry as a key intermediate used in the synthesis of Bilastine, a non-sedating antihistamine prescribed for allergic rhinitis and chronic urticaria. As a vital building block in the final steps of Bilastine production, this compound plays a significant role in ensuring both the efficacy and safety of the end pharmaceutical product.

Due to its critical application and complex structure, the manufacturing of this compound demands advanced chemical synthesis techniques, strict quality standards, and regulatory compliance. The compound is generally produced and supplied by specialized chemical manufacturers, particularly those that focus on active pharmaceutical ingredient (API) intermediates. In this article, we explore the manufacturing aspects, quality standards, and supply chain considerations for CAS 202189-76-2, without emphasizing any individual company or brand.

Chemical Overview

Before delving into the manufacturing domain, it's important to understand the chemical profile of this compound:

• Chemical Name: 2-[4-[1-(4,4-dimethyl-5H-oxazol-2-yl)-1-methyl-ethyl]phenyl]ethyl 4-methylbenzenesulfonate
  
  

• Molecular Formula: C₂₃H₂₉NO₄S
  
  

• Molecular Weight: 415.55 g/mol
  
  

• Appearance: White to off-white crystalline powder
  
  

• Use: Intermediate in the synthesis of Bilastine
  
  

Due to its precise structural requirements and role in drug synthesis, this compound is produced under controlled environments to ensure it meets pharmaceutical-grade standards.

The Role in Pharmaceutical Manufacturing

This compound serves as an essential intermediate in the production of Bilastine, a widely used second-generation antihistamine. Intermediates like this one are not active themselves but are crucial for building the final API molecule. The purity, stability, and structural integrity of the intermediate directly impact the quality and effectiveness of the final drug.

Because Bilastine is marketed in many countries under various brand names, the demand for its intermediates remains steady and globally distributed. This consistent demand has led to an active manufacturing ecosystem focused on intermediates like CAS 202189-76-2.

Manufacturing Challenges

The synthesis of CAS 202189-76-2 involves multiple steps of organic chemical transformations, which require precise control over reaction conditions. Manufacturers must address the following challenges:

1. Purity Requirements: The pharmaceutical industry typically requires intermediates to exceed 96% purity, with some applications demanding ≥98% purity to ensure the quality of the final API.
   
   

2. Analytical Testing: Each batch undergoes rigorous testing, often using High-Performance Liquid Chromatography (HPLC), to quantify assay values and identify impurities.
   
   

3. Regulatory Compliance: Facilities producing this compound must adhere to Good Manufacturing Practices (GMP) and often need to provide Certificates of Analysis (CoA), stability data, and other documentation for regulatory submissions.
   
   

4. Scale-Up and Reproducibility: Manufacturers must ensure that lab-scale synthesis can be reliably scaled to pilot and commercial batches without compromising yield or quality.
   
   

Production Capacities and Purity Standards

Manufacturers typically offer CAS 202189-76-2 in purity levels ranging between 96% and 99%, depending on the intended use. These purity grades are determined through analytical testing and are crucial for compliance with international pharmacopoeial standards.

The compound is generally available in small research quantities (grams to kilograms) and large-scale commercial lots (hundreds of kilograms to metric tons). Research and development institutions might source small batches for formulation studies, while API producers order in bulk for continuous production.

Supply Chain and Sourcing Considerations

The global supply chain for pharmaceutical intermediates is robust yet sensitive to changes in demand, raw material availability, and international trade policies. Sourcing CAS 202189-76-2 involves several critical factors:

1. Regulatory Requirements

Buyers must ensure that the supplier follows relevant guidelines such as ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients). Intermediates used in regulated markets (e.g., U.S., EU) may require documentation that proves the absence of harmful impurities or residual solvents.

2. Lead Time and Logistics

The average lead time can range from 2 to 6 weeks depending on the production batch size and location. Because most manufacturers are based in Asia, particularly in China and India, shipping regulations, port availability, and customs clearance processes must be considered.

3. Packaging and Storage

This compound must be stored in airtight, light-resistant containers to prevent degradation. Standard packaging options include HDPE drums and aluminum foil pouches with desiccants. Shelf life typically extends up to two years if stored under recommended conditions.

Quality Control and Documentation

A critical component of intermediate manufacturing is documentation. The following documents are commonly supplied with each shipment:

• Certificate of Analysis (CoA): Details assay, impurities, appearance, moisture content, and more.
  
  

• Stability Data: For certain regulated markets, long-term and accelerated stability data may be requested.
  
  

• Analytical Method Validation: Details on HPLC or GC methods used to assess purity and related substances.
  
  

Environmental and Safety Considerations

Handling CAS 202189-76-2 requires adherence to chemical safety protocols. It is not classified as a highly hazardous substance, but due to its organic composition and potential byproducts during synthesis, manufacturers must manage:

• Waste disposal in line with local and international environmental regulations.
  
  

• Air emissions and solvent recovery where applicable.
  
  

• Worker protection via proper use of PPE and ventilation.
  
  

As environmental standards grow stricter, many manufacturers are investing in green chemistry approaches and improved effluent treatment systems to reduce their ecological footprint.

Market Outlook

The market demand for CAS No: 202189-76-2 is projected to grow steadily in line with increased production and prescription of Bilastine. The prevalence of allergies, urban pollution, and the global shift toward second-generation antihistamines without sedative effects contribute to sustained interest in this compound.

As more generic drug producers enter the market, the competition for high-purity intermediates at competitive prices will intensify. Manufacturers able to balance cost, compliance, and quality will likely be preferred partners for pharmaceutical firms worldwide.

Conclusion

CAS No: 202189-76-2 is a crucial pharmaceutical intermediate with high relevance in the synthesis of Bilastine. Its manufacture requires expertise in chemical synthesis, quality control, regulatory compliance, and environmental safety. As demand for Bilastine continues to grow globally, so too will the importance of reliable, high-purity intermediate suppliers.

Whether for research or large-scale production, sourcing this compound requires thorough evaluation of technical specifications, certifications, and delivery timelines. Manufacturers who meet these expectations play a key role in ensuring the smooth functioning of the pharmaceutical supply chain and the availability of effective medications worldwide.