(2'R)-2'-Deoxy-2'-Fluoro-2'-Methyl-Uridine: Pharma Grade Substance Profile

What is (2'R)-2'-Deoxy-2'-Fluoro-2'-Methyl-Uridine?

(2'R)-2'-Deoxy-2'-Fluoro-2'-Methyl-Uridine stands out as a specialized nucleoside designed for modern pharmaceutical synthesis. This compound falls under the BP, EP, USP pharma grade, meaning it gets manufactured under tight standards established by the British, European, and United States Pharmacopeias. Strict specifications back every batch, making it viable for direct API or intermediate use in several key therapeutic classes. Manufactured for environments that value purity and traceability, this uridine analog delivers consistency in high-stakes pharmaceutical operations.

Physical Properties and Appearance

By all accounts, this compound usually appears as a white to off-white solid. It can come in forms like flakes, fine powder, small crystalline pearls, or occasionally a granular solid, depending on processing and manufacturer specifications. Industrial settings often store and handle the material as a powder for easy transfer and measurement, though some advanced synthesis steps may dissolve it in suitable solvents. The molecular formula is C10H13FN2O5, tying it closely to natural nucleosides but with that crucial fluoro and methyl tweak. Packing density hovers around 1.5 g/cm³, typical for nucleoside analogs, which aligns with handling norms for these solid-state raw materials.

Molecular Structure

Chemists can break down its structure like this: a uridine backbone sits at the core, but at the 2’ position on the deoxyribose, a fluorine and a methyl group replace their usual hydrogen partners. Molecularly, this creates a balance of hydrophilic and hydrophobic character that impacts melting point, crystal habit, and solubility. While the standard nucleoside structure supports base pairing, the chemical modifications restrict or alter those interactions, making this variant important for next-generation medicinal research, especially in RNA-centric therapies and antivirals.

Specs and Safety

Pharma grade guidelines set tight specification limits on impurities (often less than 0.1%), heavy metals (often less than 10 ppm), and residual solvents. High-performance liquid chromatography (HPLC) and nuclear magnetic resonance (NMR) methods confirm identity and purity. The HS Code, used for customs and trade, usually falls under 2934999090 for research chemicals and pharmaceutical raw materials. Every manufacturer’s COA (certificate of analysis) must show full transparency, documenting water content (usually under 1.0% by Karl Fischer titration) and particle size distribution.

Handling and Storage

(2'R)-2'-Deoxy-2'-Fluoro-2'-Methyl-Uridine, in its dry powder or solid state, holds up best in amber glass or sealed polyethylene containers out of direct sunlight. Storage at room temperature below 25°C with minimal humidity preserves both its crystalline structure and chemical activity. Solubility can depend on pH and solvent polarity; common solvents include dimethyl sulfoxide (DMSO) or sterile water for injection. Safe handling demands gloves, protective eyewear, and well-ventilated lab environments. This substance isn’t volatile nor particularly reactive, but dust inhalation and repeated dermal contact still require basic industrial hygiene, as with all cytidine or uridine analogs.

Material Hazards

While not outright dangerous for short-term handling, this compound can disrupt normal enzyme function in cellular machinery if inhaled or ingested over time. Classified as potentially harmful in GHS safety hierarchies, exposure limits should never be exceeded. Spills require immediate cleanup with HEPA-filtered vacuums or wet methods; dry sweeping can aerosolize fine powder. Waste generated from synthesis or expired material routes out as hazardous chemical waste, as outlined by environmental health and safety protocols for all pharma-grade nucleoside analogs.

Role as a Raw Material

Pioneers in biotech and pharma turn to (2'R)-2'-Deoxy-2'-Fluoro-2'-Methyl-Uridine for more than just its structural quirks. In antiviral drug synthesis, the fluorine at the 2' position imparts viral resistance and metabolic stability, opening new doors for precision RNA drugs or selective molecular diagnostics. In my experience, seeing research teams scale from bench to kilo-lab scale, the quality and batch consistency of such raw materials directly affect reproducibility and regulatory clearance. Cost, accessibility, and lead times on these specialty chemicals often dictate the pace of early-phase trials and pilot toxicology studies. Getting the handling right minimizes cross-contamination and batch loss, two setbacks that slow innovation across the sector.

Solutions and Best Practices

To tackle the risks and maximize its potential, I’ve seen life sciences teams double down on process SOPs and supplier qualification. This means sourcing only from manufacturers with ISO, GMP, or equivalent certifications; random lot sampling for independent lab validation; and digital tracking of each consignment using barcoded HS codes. On the research side, toolkits for powder handling—think gloveboxes, dust extractors, and proper labeling—reduce accidental exposures and streamline compliance audits. For waste management, dedicated bins and regular hazardous waste pickups make sure leftovers don’t turn up somewhere they shouldn’t. Teams that train every new technician on the particulars of these nucleoside derivatives see far fewer safety incidents and less lost product.