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3',5'-Di-O-Benzoyl-2',2'-Difluoro-2'-Deoxy Cytidine BP EP USP Pharma Grade: Detailed Reference Guide

What is 3',5'-Di-O-Benzoyl-2',2'-Difluoro-2'-Deoxy Cytidine?

3',5'-Di-O-Benzoyl-2',2'-Difluoro-2'-Deoxy Cytidine stands out as a critical pharmaceutical intermediate, often encountered in advanced research facilities and pharmaceutical manufacturing setups. This compound represents a fine marriage of synthetic chemistry and applied pharmacology, bridging lab-based innovation and the robust demands of regulated manufacturing. To many in the field, its name signals a commitment to deep molecular engineering, supporting both innovation and safe medicine production.

With its precise chemical design, the structure involves a cytidine backbone where two fluorine atoms replace hydrogens on the sugar ring, and a benzoyl group attaches at the 3' and 5' positions. Researchers and manufacturers alike recognize the value of these modifications—they bring improvements in metabolic stability and bioavailability. This is not just a theoretical benefit. Data from published pharmaceutical studies show analogues like this can deliver higher efficacy and longer action when used as raw materials or intermediates in antiviral or anticancer drug synthesis.

Physical and Chemical Properties

Looking at the substance, those who handle the raw material describe it as a crystalline solid, often presenting in white to off-white flakes or powder. Visual cues like these help verify its purity before any advanced tests start. The appearance as flakes or crystalline powder signals consistent process control in both synthesis and purification. Density measures typically range from about 1.3 to 1.5 g/cm3, a direct result of its benzoate and difluoro modifications. This density impacts how you store, transport, and dissolve the compound—practical matters that anyone working with scale-up operations or formulation will respect.

Molecular formula comes in as C21H15F2N3O6. The molecular weight measures approximately 443.36 g/mol. Both numbers matter in real-world settings; dosing, handling, safety documentation, and quality control all depend on them. Solubility sits on the lower end in water, but many organic solvents offer much higher dissolution, something every laboratory technician considers essential for rapid process transitions. The structure, bracketing benzoyl protection and difluoro substitution, fixes the compound’s stability window and influences reactivity in downstream steps.

Those in manufacturing note the compound’s melting point usually appears between 144-150°C based on literature and technical sheets. Handling characteristics like powder flow and static tendency draw attention in GMP settings, as these affect yield, safety, and clean-up routines. The form—flakes, powder, or crystalline solid—dictates everything from how the material packs in drums to how much time workers spend getting it into solution.

Specifications and Regulatory Identifiers

Pharma grade 3',5'-Di-O-Benzoyl-2',2'-Difluoro-2'-Deoxy Cytidine meets several recognized standards, including British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP). Each system offers guidelines that shape purity, allowable impurity profile, and traceable batch manufacturing. These grades function as more than labels; anyone who’s been part of facility audits or regulatory submissions knows the pressure that comes with them. Certificates of analysis report heavy metals, moisture, residual solvents, and related compounds—all before a batch leaves the factory.

The HS Code for this chemical sits under 29349900. Those importing or exporting at scale watch this classification; it directs how customs inspections happen, impacts tariffs, and determines required documentation. More than a technicality, this numeric handle can speed movement across borders—a crucial point in a market where delays reduce competitiveness and disrupt supply chains serving patient needs.

Applications and Use in Advanced Pharmaceuticals

In the real world of pharmaceutical R&D, the adoption of this di-benzoyl, difluoro cytidine variant helps scientists create next-generation nucleoside analogues—critical for treating viral infections or certain cancers. The difluoro substitution enhances the molecule’s ability to evade breakdown by metabolic enzymes, extending its effective shelf life in biological systems. Benzoyl protection shields sensitive parts of the molecule through demanding chemical transformations, allowing for cleaner synthesis and improved yields.

Production lines, from small academic labs to high-throughput pharmaceutical plants, rely on these properties. Staff know from day-to-day experience that having a raw material with consistent appearance, reactivity, and documented purity isn’t about ticking regulatory boxes; it means fewer failed batches, smoother production cycles, and more confidence when moving to late-stage or commercial manufacturing.

Handling, Safety, and Environmental Concerns

Experience in chemical storerooms and formulation suites brings a healthy respect for safety and material management. 3',5'-Di-O-Benzoyl-2',2'-Difluoro-2'-Deoxy Cytidine, like many fine chemicals, calls for secure storage—cool, dry, with minimal light exposure. Packaging often consists of double-bagging inside sealed HDPE or glass containers to limit moisture ingress and cross-contamination. Each drum or jar comes tagged with batch numbers, supplier details, and safety instructions reflecting its hazardous status.

Material Safety Data Sheets for this compound note typical risks, such as eye or skin irritation on contact. Those who work with it wear gloves, safety glasses, and lab coats—protection learned by experience rather than just compliance. If a spill occurs, cleanup uses inert absorbents and prompt reporting, putting health before hurry. Waste routes must comply with regulations for pharmaceuticals and fluorinated organics, a fact that lab managers and waste contractors confirm during every routine audit.

Addressing Challenges: Authenticity, Safety, and Sustainability

Counterfeit and substandard raw materials threaten not just production timelines but patient safety. In my experience, reliance on trusted suppliers and rigorous quality checks reduces these risks. Traceable documentation and batch retention improve transparency. Industry news tells stories about the dangers of shortcuts—once burnt, most never risk it again. Regular staff training supports safe handling, and well-designed facilities sustain material quality over months or years.

Sustainability keeps growing as a concern, especially when dealing with fluorinated compounds. Teams in progressive facilities explore greener syntheses, solvent recovery, and energy-efficient drying, because the pharmaceutical sector faces increasing regulation and societal expectation to reduce environmental impact. These efforts serve more than image; they bring cost savings and reduce the number of regulatory headaches, helping companies survive and adapt in a quickly changing world.

Conclusion

Working with 3',5'-Di-O-Benzoyl-2',2'-Difluoro-2'-Deoxy Cytidine means working at the crossroads of chemical engineering, regulatory science, and practical safety. The substance’s precise properties—solid, dense, visually stable, with fine-tuned solubility and trustworthy documentation—don’t just serve technical purposes; they anchor the reliability and efficiency of medicinal chemistry innovations. In pharmaceutical manufacturing, the experience of handling, adapting, and complying with every detail brings the industry closer to delivering life-saving products with speed and safety.