The Essential D-Enantiomer Reference Standard for Chiral Purity Control in [¹⁸F]FET PET Tracer Manufacturing and Neurological Research: D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate (CAS# 223463-90-9)

D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate (CAS# 223463-90-9), also known as D-FETFA, O-(2-fluoroethyl)-D-tyrosine trifluoroacetate, or D-FET free base trifluoroacetate salt, is a fluorinated chiral amino acid derivative with the molecular formula C₁₁H₁₄FNO₃·C₂HF₃O₂ and a molecular weight of 341.25 g/mol. Its molecular structure consists of a D-tyrosine backbone bearing a 2-fluoroethoxy substituent at the para-hydroxyl position of the aromatic ring, presented as the trifluoroacetate salt. The D-configuration at the α-carbon distinguishes this compound from its L-enantiomer counterpart and is critical for its role as the definitive chiral reference standard in [¹⁸F]FET PET tracer quality control.

As a colorless to pale yellow solid, the compound is soluble in water and polar organic solvents, with a purity of ≥95% typically available. It should be stored at −20°C in a dry, dark place under sealed conditions. The trifluoroacetate salt form provides enhanced water solubility and stability compared to the free base, facilitating its use in chiral HPLC analysis and analytical method development. This compound serves as the indispensable D-enantiomer reference standard for the radiosynthesis of O-(2-[¹⁸F]fluoroethyl)-L-tyrosine ([¹⁸F]FET), enabling the critical chiral purity assessment that ensures the absence of the D-enantiomer impurity in the final PET tracer product. Based on its chemical characteristics and biomedical significance, this article systematically analyzes the key properties, core application areas, global market structure, regulatory landscape, and future outlook of this strategically important chiral reference standard.

Key Properties and Reactivity Profile

D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate (CAS# 223463-90-9) is a D-enantiomer fluorinated chiral amino acid derivative whose value derives from its well-defined stereochemistry and analytical characteristics.

Key physicochemical parameters include:

• Molecular Formula: C₁₁H₁₄FNO₃·C₂HF₃O₂
• Molecular Weight: 341.25 g/mol (trifluoroacetate salt); 227.23 g/mol (free base)
• CAS Number: 223463-90-9
• Synonyms: D-FETFA; O-(2-Fluoroethyl)-D-tyrosine trifluoroacetate; D-FET trifluoroacetate
• IUPAC Name: (2R)-2-amino-3-[4-(2-fluoroethoxy)phenyl]propanoic acid
• Appearance: Colorless to pale yellow solid
• Purity: ≥95% (HPLC)
• Solubility: Soluble in water and polar organic solvents
• Storage: −20°C, dry, dark place, sealed conditions
• SMILES: C1=CC(=CC=C1CC@HN)OCCF
• InChIKey: QZZYPHBVOQMBAT-SECBINFHSA-N
• FDA UNII: 6D1N5F5PSR

The compound’s reactivity is defined by the D-tyrosine amino acid backbone, which enables peptide coupling and derivatization, and the fluoroethoxy substituent, which provides a site for radiolabeling with ¹⁸F. The D-configuration at the α-carbon is the defining structural feature—this stereochemistry is critical for the compound’s function as the D-enantiomer reference standard in chiral HPLC analysis, enabling the definitive identification and quantification of D-FET impurity in [¹⁸F]FET preparations. The trifluoroacetate counterion enhances water solubility and facilitates chromatographic analysis. Substituting the D-configuration with the L-enantiomer (CAS 854750-33-7) would fundamentally alter the compound’s chromatographic retention behavior and its utility as the D-FET reference standard.

Core Application Fields and Demand

Market demand for D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate (CAS# 223463-90-9) is concentrated in three primary sectors: chiral reference standards for PET tracer quality control (approximately 55–60% of global consumption), neurological research and tracer development (approximately 25–30%), and pharmaceutical quality control and analytical method validation (approximately 10–15%). Its unique D-enantiomer configuration and essential role in chiral HPLC analysis serve as the core drivers of sustained demand growth.

In chiral reference standards for PET tracer quality control, this compound is the definitive D-enantiomer reference standard for the radiosynthesis of O-(2-[¹⁸F]fluoroethyl)-L-tyrosine ([¹⁸F]FET). In automated radiochemical synthesis, the enantiomeric purity of [¹⁸F]FET is routinely assessed using chiral HPLC analysis, which requires co-injection with authentic L-FET and D-FET standards to confirm the absence of racemization and the D-enantiomer impurity. Enantiomeric purity of >99% is consistently achieved and confirmed by chiral HPLC co-injection with L-FET and D-FET authentic standards. The D-FETFA reference standard enables the definitive identification and quantification of the D-FET impurity, ensuring that the final PET tracer product meets the stringent radiochemical and enantiomeric purity requirements for clinical use. Without this D-enantiomer reference standard, regulatory-compliant chiral purity assessment of [¹⁸F]FET would be impossible, making this compound a critical component of the PET tracer manufacturing quality control chain.

In neurological research and tracer development, this compound serves as a valuable research tool for investigating the biological behavior of D-enantiomer amino acid tracers. Comparative studies of D-FET and L-FET transport across the blood-brain barrier have been conducted using PET in anesthetized piglets and patients after subtotal resection of brain tumors. In piglets, the initial brain uptake of D-FET was more than two-fold higher than that of L-FET, with the rate constant for blood-brain transfer (K₁) approximately 4-fold higher for D-FET compared to L-FET. Affinity determinations on various amino acid transporters (LAT1, LAT2, PAT1, XPCT) using unlabeled D-FET and L-FET have provided critical insights into the differential transport mechanisms of D- and L-enantiomers across the blood-brain barrier. In brain tumor patients, initial D-FET uptake was similar to that of L-FET but showed faster tracer washout, whereas L-FET uptake remained rather constant and provided a better tumor-to-background ratio. These studies have established D-FET as a valuable research tool for understanding enantioselective amino acid transport in the brain, and D-FETFA serves as the essential non-radioactive reference material for these investigations.

In pharmaceutical quality control and analytical method validation, this compound is utilized as a reference standard for the identification and quantification of related substances in pharmaceutical formulations containing fluorinated amino acid derivatives. The compound’s well-characterized structure, defined stereochemistry, and high purity make it suitable for use in analytical method development, validation, and quality control in the radiopharmaceutical industry. It enables the development of robust chiral HPLC methods for enantiomeric purity assessment, ensuring batch-to-batch consistency and regulatory compliance in PET tracer manufacturing.

Major Market Participants

The global supply system for D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate (CAS# 223463-90-9) features a pattern of “specialized radiopharmaceutical chemical suppliers, research-grade chemical distributors, and Chinese manufacturers serving distinct market segments.” As a highly specialized chiral reference standard rather than a commodity chemical, the market is characterized by a limited number of suppliers catering to the radiopharmaceutical, pharmaceutical R&D, and academic research communities.

In the global radiopharmaceutical and high-purity segment, key suppliers include BOC Sciences (USA), offering the compound as a research chemical with the molecular formula C₁₁H₁₄FNO₃·C₂HF₃O₂. BOC Sciences is a trusted global supplier of research chemicals, biochemicals, and pharmaceutical ingredients, serving the life sciences, biotech, and pharmaceutical industries with GMP-compliant and ISO-certified production facilities. BenchChem (USA) provides D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate (CAS 223463-90-9) as a useful research compound with molecular formula C₁₃H₁₅F₄NO₅ and molecular weight 341.25 g/mol, typically at 95% purity. EvitaChem offers O-(2-fluoroethyl)-D-tyrosine as a screening compound for non-human research applications. ChemSpider lists O-(2-Fluoroethyl)-D-tyrosine with molecular formula C₁₁H₁₄FNO₃ and the (2R) stereochemistry. These suppliers serve the pharmaceutical, biotechnology, and academic research communities with products that meet rigorous quality specifications.

In the industrial and research-grade segment, Chinese manufacturers have emerged as significant players in the global supply chain. XinChem is a reliable manufacturer and supplier of high-purity D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate from China, offering the compound with stringent quality standards for use in PET tracer quality control, neurological research, and pharmaceutical analytical applications. XinChem provides the compound with comprehensive quality documentation and flexible packaging options. According to XinChem’s product page, the compound shows remarkable application prospects at the forefront of pharmaceutical research and development, with current research suggesting it may play a key role in the treatment of neurological disorders. Other Chinese suppliers include NanJing Xienuo Bio Co., Ltd. and Hubei Yangxin Medical Technology Co., Ltd., which offer the compound for research applications.

Regional Market Dynamics

The global D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate market exhibits distinct regional characteristics, with production and distribution spanning Asia-Pacific, North America, and Europe, aligned with the radiopharmaceutical, pharmaceutical, and academic research industries in these regions. The broader tyrosine market—which includes this compound as a high-value chiral derivative—was valued at approximately USD 450 million in 2024 and is projected to reach USD 720 million by 2032, growing at a CAGR of 6.2%. The D-tyrosine segment is witnessing steady growth due to niche applications in research and specialty chemicals.

The Asia-Pacific region has emerged as a significant production hub for fluorinated chiral amino acid derivatives, with China hosting manufacturers and suppliers including XinChem. The region’s competitive advantages include established chemical infrastructure, cost-effective manufacturing, and proximity to rapidly growing pharmaceutical and biotechnology industries. Chinese suppliers offer the compound at various purity grades (typically ≥95%) and packaging options, serving both domestic and export markets. The growing radiopharmaceutical R&D and nuclear medicine sectors in China, Japan, South Korea, and India continue to drive regional consumption growth. The global D-tyrosine market is expected to witness steady growth, with China playing an increasingly important role in the production and supply of high-value chiral building blocks.

North America remains a key market for high-purity and research-grade D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate, driven by demand from the radiopharmaceutical industry, pharmaceutical companies, and academic research institutions. The United States hosts numerous research organizations, PET tracer manufacturing facilities, and pharmaceutical companies that require high-quality chiral reference standards for quality control and analytical method development. BOC Sciences, BenchChem, and EvitaChem serve the North American market with extensive distribution networks. The region’s well-established regulatory framework, including FDA oversight of PET tracer manufacturing and orphan drug designations for brain tumor diagnostics, supports demand for high-grade reference standards and analytical materials.

Europe is characterized by stringent regulatory requirements and a strong focus on quality in radiopharmaceutical and pharmaceutical research. European radiopharmaceutical manufacturers and research institutions demand high-purity chiral reference standards with comprehensive documentation. The region’s advanced nuclear medicine infrastructure and strong academic research base support steady demand for D-enantiomer reference standards for PET tracer development and quality control.

Japan represents a specialized market where D-FETFA is applied in advanced radiopharmaceutical research, brain tumor imaging tracer development, and chiral analytical method validation programs.

Regulatory and Safety Considerations

As a research chemical, radiopharmaceutical reference standard, and pharmaceutical analytical material, D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate (CAS# 223463-90-9) is subject to regulatory oversight in major global economies. Compliance with relevant regulations is essential for market access and trade.

Regulatory compliance: In the United States, the compound has a FDA Unique Ingredient Identifier (UNII) of 6D1N5F5PSR. The FDA Substance Registration System lists the compound under the preferred substance name D-TYROSINE, O-(2-FLUOROETHYL)-. The compound is not a controlled substance and is intended for research and development use only.

In the European Union, the compound must comply with REACH registration requirements for import and use. Manufacturers and suppliers must provide comprehensive Safety Data Sheets (SDS) and maintain appropriate documentation.

GHS classification and handling: Standard laboratory safety practices should be followed during handling, including the use of appropriate personal protective equipment (gloves, protective clothing, and eye/face protection). The compound should be stored at −20°C in a dry, dark place under sealed conditions, protected from moisture and light. The trifluoroacetate salt form is moisture-sensitive and should be handled under inert atmosphere when possible.

Transport information: D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate is not classified as hazardous material for DOT/IATA transport purposes. Proper packaging, labeling, and documentation are nevertheless required for international shipping. The compound is typically shipped with appropriate temperature control and moisture protection.

Future Outlook

The market outlook for D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate is positive, supported by several key growth drivers across its major application segments. While the compound remains a relatively specialized chiral reference standard, its essential role in [¹⁸F]FET PET tracer quality control and neurological research positions it for steady growth in the coming years. The broader tyrosine market is projected to grow from USD 450 million in 2024 to USD 720 million by 2032 at a CAGR of 6.2%.

Key growth drivers include:

1. Expansion of the PET imaging market and [¹⁸F]FET adoption: The growing global demand for PET imaging in oncology and neurology drives demand for high-quality PET tracers and their quality control reference standards. The clinical adoption of [¹⁸F]FET for brain tumor imaging—with its ability to demonstrate specific uptake only in tumor tissue while showing almost negligible uptake in normal brain tissue—supports demand for the D-FETFA reference standard for chiral purity assessment.
2. Growth in brain tumor diagnostics and neurological research: The increasing incidence of brain tumors and the need for non-invasive diagnostic tools support continued demand for [¹⁸F]FET PET imaging and the associated quality control materials. Comparative studies of D-FET and L-FET transport have established the scientific foundation for understanding enantioselective amino acid transport in the brain, supporting ongoing research demand.
3. Increasing regulatory requirements for chiral purity in radiopharmaceuticals: The growing stringency of regulatory requirements for enantiomeric purity assessment in PET tracer manufacturing drives demand for well-characterized D-enantiomer reference standards.
4. Expansion of radiopharmaceutical R&D and production: Increasing investment in the development and production of novel radiopharmaceuticals and PET tracers supports demand for high-quality chiral reference standards and analytical materials.
5. Growth in D-amino acid research: The recognition of D-amino acids’ biological significance—including D-serine as a co-agonist at NMDA receptors—supports demand for D-enantiomer research tools and reference standards.

Challenges and considerations:

• Regulatory compliance: Increasingly stringent pharmaceutical and radiopharmaceutical regulations may require ongoing investment in quality systems and documentation.
• Limited scale: As a highly specialized chiral reference standard, the market for D-FETFA is smaller than that of commodity chemicals, which may limit investment in large-scale production capacity.
• Technical complexity: The synthesis of enantiopure D-fluorinated amino acid derivatives requires specialized expertise and equipment, creating barriers to entry.
• Cold chain requirements: The compound requires storage at −20°C, which may increase handling and logistics costs.
• Competition from alternative quality control methods: The market faces competition from alternative chiral purity assessment methods, though co-injection with authentic standards remains the gold standard for enantiomeric purity confirmation.

To succeed in this evolving market landscape, suppliers must focus on product quality (particularly enantiomeric purity and batch-to-batch consistency), supply chain reliability, regulatory compliance, and responsive customer service. Companies that can offer high-purity products with comprehensive Certificates of Analysis (COA) documenting enantiomeric purity, flexible packaging options, and technical support for radiopharmaceutical and neurological research applications will be well-positioned to capture growing demand.

Shanghai XinChem Co., Ltd. (XinChem)

As a world-leading supplier of organic chemicals and pharmaceutical intermediates, Shanghai XinChem Co., Ltd. (XinChem) is dedicated to meeting the innovative needs of the radiopharmaceutical, pharmaceutical, biotechnology, and fine chemical industries. Leveraging extensive experience and advanced manufacturing capabilities, XinChem provides high-quality D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate (CAS# 223463-90-9) to customers worldwide. As a trusted manufacturer and supplier based in China, XinChem combines competitive pricing, reliable supply, and exceptional service to establish itself as a preferred partner for businesses and research institutions seeking this essential D-enantiomer chiral reference standard.

1. Technical Advantages

Advanced Synthesis and Purification Processes
XinChem utilizes state-of-the-art manufacturing facilities and rigorous quality control measures to ensure the purity, consistency, and safety of its D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate products. The production process incorporates advanced synthetic technologies—including chiral synthesis, fluoroethylation, and trifluoroacetate salt formation—enabling the delivery of products with purity ≥95% (HPLC) to meet diverse application requirements. Strict process control ensures consistent enantiomeric purity (D-configuration), minimal impurities, and batch-to-batch reproducibility, providing customers with reliable performance in chiral HPLC analysis, radiopharmaceutical quality control, and neurological research applications. According to XinChem’s product documentation, the preparation of high-purity and stable D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate requires strict adherence to precise and complex operation procedures, relying on exquisite and skilled organic synthesis technology, from careful selection of initial raw materials to precise control of temperature and pH in the reaction process, and efficient purification and fine separation of the final product.

Full-Chain Quality Control
The production process strictly adheres to international quality standards, with comprehensive quality control covering raw material sourcing, in-process monitoring, and finished product testing. Each batch is accompanied by a detailed Certificate of Analysis (COA) documenting physical and chemical properties, purity data (HPLC), enantiomeric purity, and impurity profiles. This commitment to quality ensures that XinChem’s D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate meets the stringent requirements of radiopharmaceutical quality control, pharmaceutical analytical applications, and research use.

2. Product Advantages

High Purity and Consistent Quality
XinChem offers D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate with purity ≥95% (HPLC), ensuring optimal performance in chiral HPLC analysis, PET tracer quality control, and neurological research applications. The product’s high purity and consistent enantiomeric configuration minimize the risk of analytical interference, making it suitable for demanding applications in radiopharmaceutical manufacturing quality control.

Comprehensive Specifications
Key specifications include:

• Molecular Formula: C₁₁H₁₄FNO₃·C₂HF₃O₂
• Molecular Weight: 341.25 g/mol (trifluoroacetate salt); 227.23 g/mol (free base)
• CAS Number: 223463-90-9
• Synonyms: D-FETFA; O-(2-Fluoroethyl)-D-tyrosine trifluoroacetate; D-FET trifluoroacetate
• IUPAC Name: (2R)-2-amino-3-[4-(2-fluoroethoxy)phenyl]propanoic acid
• Appearance: Colorless to pale yellow solid
• Purity: ≥95% (HPLC)
• Solubility: Soluble in water and polar organic solvents
• Storage: −20°C, dry, dark place, sealed conditions
• FDA UNII: 6D1N5F5PSR

Flexible Packaging Solutions
XinChem provides a range of packaging options to accommodate diverse customer needs, from laboratory-scale quantities (10 mg, 20 mg, 50 mg, 100 mg) to industrial-scale packaging (500 mg, 1 g, 5 g) and bulk shipments. Customized packaging solutions are available upon request, ensuring safe handling, storage, and transportation with appropriate temperature control and moisture protection.

3. Application Fields

As a versatile D-enantiomer chiral reference standard, D-Tyrosine, O-(2-fluoroethyl)-, trifluoroacetate (CAS# 223463-90-9) exhibits wide application value across multiple industries:

Chiral Reference Standards for PET Tracer Quality Control:

• Definitive D-enantiomer reference standard for [¹⁸F]FET chiral purity assessment
• Co-injection standard for chiral HPLC analysis to confirm enantiomeric purity >99%
• Quality control reference material for PET tracer manufacturing

Neurological Research and Tracer Development:

• Research tool for studying enantioselective amino acid transport across the blood-brain barrier
• Comparative studies of D-FET and L-FET transport mechanisms
• Investigation of amino acid transporter affinity (LAT1, LAT2, PAT1, XPCT)
• Tool for understanding enantioselective pharmacokinetics of fluorinated amino acid tracers

Pharmaceutical Quality Control and Analytical Method Validation:

• Reference standard for chiral HPLC and LC-MS method development
• Quality control material for radiopharmaceutical production
• Analytical standard for enantiomeric purity assessment

4. Service Support

Technical Expertise and Customized Solutions
XinChem’s team of experienced chemists and pharmaceutical scientists provides full technical support throughout the customer journey—from product selection and specification development to application guidance and troubleshooting. Whether customers require optimization of chiral HPLC methods, guidance on handling and storage, or assistance with regulatory documentation, XinChem’s technical experts are ready to help. Custom synthesis and contract manufacturing with flexible scaling from R&D to commercial quantities are available upon request.

Global Logistics and Reliable Supply
With established supply chains serving markets across Europe, North America, Asia-Pacific, and beyond, XinChem ensures timely delivery and consistent product availability. The company’s logistics team manages all aspects of international shipping, including customs clearance and documentation, with appropriate temperature control (−20°C) and moisture protection for product stability.

Regulatory Support
XinChem provides comprehensive documentation to support regulatory compliance, including Safety Data Sheets (SDS), Certificates of Analysis (COA), and other required certificates. The company stays current with evolving regulatory requirements in major markets, including FDA, EMA, REACH, and other regional regulations, helping customers navigate the complexities of global trade.

5. Reasons to Choose XinChem

• Professionalism: Extensive experience and deep expertise in fluorinated chiral compound synthesis and supply.
• Quality: Rigorous quality control, high purity (≥95%), and adherence to international standards.
• Reliability: Stable supply, competitive pricing, and timely delivery.
• Flexibility: Customized solutions to meet diverse customer needs, including custom synthesis and packaging.
• Service: Responsive technical support and comprehensive documentation.

Contact us today to start your partnership with XinChem!

Website: www.xinchem.com

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