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(2S,5R)-5-Fluoro Cytosine-1-Yl-[1,3]-Oxathiolane-2-Carboxylic Acid Menthyl Ester (Fcme) BP EP USP Pharma Grade

What is (2S,5R)-5-Fluoro Cytosine-1-Yl-[1,3]-Oxathiolane-2-Carboxylic Acid Menthyl Ester (Fcme)?

(2S,5R)-5-Fluoro Cytosine-1-Yl-[1,3]-Oxathiolane-2-Carboxylic Acid Menthyl Ester, often abbreviated as Fcme, belongs to the growing field of advanced pharmaceutical raw materials. This compound finds its main use in research and development work, especially where nucleoside analogs play a pivotal role. The importance of Fcme links directly to the construction of key intermediates in the synthesis of active pharmaceutical ingredients (APIs) that have established benefits for patients and researchers alike. Fcme is recognized under several pharmacopoeia standards, including BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia), speaking to its purity and compliance demanded by the industry.

Physical and Chemical Properties

People looking at Fcme should focus on its physical form, molecular characteristics, and handling requirements. In appearance, Fcme can occur as a fine crystalline solid, flecked with the subtle shine of high-purity materials. The solid form is essential in the handling and measurement for precise dosages, though batch forms may include flakes or powder, which aids solubility studies. As a raw material, the compound’s exact density and melting point serve as crucial data both for formulation scientists and for those in quality assurance. The density tells chemists and engineers how Fcme behaves under different conditions, preventing costly errors during scale-up or transport. Molar mass and molecular formula form the basis of any raw material overview: for Fcme, this is C16H21FN3O4S, a mouthful on paper but a clear code to process chemists.

Molecular Structure and Specifications

A well-defined structure sets Fcme apart from less sophisticated raw materials. The oxathiolane ring system with an exactly configured (2S,5R)-stereochemistry forms the backbone that imparts selectivity in downstream synthesis. The presence of a 5-fluorocytosine base not only boosts its application spectrum but also introduces fluorine — a sought-after element in medicinal chemistry for tweaking metabolic pathways and improving bioavailability. One cannot ignore the menthyl ester moiety that uniquely supports lipophilicity and, by extension, possible membrane permeability advantages in research settings. These features support the compound’s value and dictate strict control on specifications such as purity (often at or above 99%), moisture content (to prevent degradative side reactions), specific optical rotation, and structural homogeneity checked by NMR and HPLC.

HS Code and Regulatory Considerations

Correctly using the Harmonized System (HS) Code matters in a global supply chain where customs entries decide efficiency and legal compliance. Fcme, classified as a pharmaceutical intermediate, typically falls under an HS Code starting with 293499—reserved for heterocyclic compounds with nitrogen heteroatoms. The accuracy in code assignment saves time and aligns with international regulatory requirements, reducing delays at ports or borders.

Handling, Safety, and Environmental Hazards

Every chemist knows respect for hazardous potential separates safe labs from incident reports. Fcme, though not widely labeled as harmful in small quantities, demands standard laboratory PPE — gloves, goggles, lab coats — on every shift. Fine solids can irritate respiratory pathways and must not become airborne in unventilated areas. SDS documentation advises rinsing after skin contact and mandates spill containment with inert absorbents. Waste routes follow chemical waste protocols, not domestic drainage, based on Fcme’s persistence under environmental conditions. Those with responsibilities for purchasing or storing this compound should maintain proper segregation and record-keeping: this preserves both research integrity and legal compliance, especially given the international movement across labs and countries.

Material Forms and Solubility

Researchers work with Fcme in multiple presentations — from tightly packed solid flakes to free-flowing powders. Paste-like consistency may show up during humid months, and this can impact weighing accuracy. In solution form, Fcme provides stability in select organic solvents, like dichloromethane or acetonitrile, important for reaction set-up and analysis. Given its delicate nature, the compound stores best in cool, dry places, sealed from atmospheric moisture and light. The choice between flakes, powders, and crystalline form depends on the downstream requirements: some processes need rapid dissolution, while others count on slow release. Understanding the morphologies lets manufacturers and laboratories pick the most efficient and least wasteful application path.

Why Fcme Matters

Engagement with Fcme connects back to medicinal chemistry advances, especially in nucleoside and nucleotide chemistry. Developers need intermediates like this, ones that carry the right balance of stability and reactivity. Supplies of raw chemicals such as Fcme shape the timelines and costs of drug development projects. Without access to high-purity, well-characterized raw materials, entire research teams slow down, and the path from discovery to patient bedside grows longer. By focusing on the details — from HS Code to density, from solid form to safe handling — researchers and suppliers keep progress steady and risks low. Confidence in Fcme means confidence in the next research step, whether that’s a first batch in the lab or a scale-up destined for regulatory approval.