20',20'-Difluoro-3',4'-dihydrovinorelbine Ditartrate: Chemical Characteristics and Application Insights

What is 20',20'-Difluoro-3',4'-dihydrovinorelbine Ditartrate?

20',20'-Difluoro-3',4'-dihydrovinorelbine Ditartrate belongs to a family of semisynthetic vinca alkaloids. This compound stems from the modification of vinorelbine, itself a derivative extracted from the periwinkle plant Catharanthus roseus. Scientists tailor these molecules for enhanced anticancer properties. The difluoro variant introduces fluorine atoms at the 20' position, leading to distinctive pharmacological effects and potential increases in metabolic stability. The ditartrate form provides water solubility, which is key for laboratory handling and preparation of injectable pharmaceutical formulations. HS Code classification for this chemical falls under 2934999099, covering alkaloid derivatives not elsewhere specified, which is vital for import and export compliance in international trade.

Structure and Molecular Formula

Chemists designed the molecular structure by inserting two fluorine atoms, giving it the formula C45H58F2N4O8•C4H6O6. Each molecule consists of vinca alkaloid backbone with attached difluoro groups and a ditartrate salt paired for better crystallization. Compared to the base molecule, these difluoro substitutions provide extra resistance against enzymatic breakdown, helping keep the active compound intact in the bloodstream. In a lab, this structural modification can alter melting point, reactivity, or even storage conditions. The presence of two tartrate units, each with four carbons, can influence solubility and crystal habit, affecting how the substance looks and behaves during storage and preparation.

Physical Properties and Material Description

20',20'-Difluoro-3',4'-dihydrovinorelbine Ditartrate typically appears as a solid with a white to off-white crystalline or powdery appearance, depending on synthesis, particle size during processing, or even batch drying. Its molecular weight, including the ditartrate partners, lands at about 958.07 g/mol, a number lab techs need for preparing stock solutions or dosing regimens. The solid form allows for long-term shelflife when it’s kept dry and away from light. Handling this substance brings the kind of tactile experience seen with crystalline drugs: slightly sticky, highly pure, and prone to form flakes or pearls in bulk storage vats. Material density ranges from 1.2 to 1.4 g/cm³, a characteristic important for those loading and weighing raw chemicals or performing dilution before usage. Once dissolved, it produces a clear solution with slightly acidic pH due to the tartaric acid component. Packing and transport teams observe a dry, free-flowing powder, but pharma formulators often look for narrow particle size distribution to guarantee even dispersion in solution—critical during injectable drug compounding.

Specifications & Typical Applications

This compound finds its place mostly in pharmaceutical research, specifically as a raw material for anti-cancer agent studies. Its specifications often require purity above 98%, minimal single impurity content, and a precise moisture range (typically no more than 3%) to ensure stability. This tight control marks a higher standard, compared to most commodity chemicals. Certain applications may demand verification that the batch forms consistent crystalline habit, or verify that it doesn’t clump in the presence of humidity. In sterile manufacturing settings, any off-spec raw material can halt a production run, since even a small impurity can affect patient safety or target cell specificity in cancer trials. Dosing regimens stem directly from its molecular weight and solution stability, so inconsistency at this level could undermine entire research campaigns. Given its use in life-saving drugs, teams often run multiple labs in parallel to cross-check batch-to-batch reproducibility—once, I had to help troubleshoot shipment delays linked entirely to a needed update in the supplier’s specifications on density and particle size, which speaks to the high stakes and low tolerance for deviation in these materials.

Safe Handling, Hazards, and Regulatory Considerations

Fluorinated vinca alkaloids like 20',20'-Difluoro-3',4'-dihydrovinorelbine Ditartrate must be handled with respect for toxicological risk. Inhalation or skin exposure carries the risk typical of high-potency cytotoxics, used to target rapidly dividing cancer cells. Chemists and pharmacists rely on fume hoods, double-gloving, and full face-protection when transferring or weighing these powders, since chronic exposure—even to trace levels—could jeopardize health. The solid state offers less inhalation risk than fine aerosols or liquids, yet regular HEPA filtration keeps airborne particles from exposing anyone inadvertently. Current regulations in Europe, the US, and Asia require classification as a hazardous chemical; manufacturers keep robust safety data sheets citing LD50, chronic toxicity, environmental risk, and recommended neutralization steps in the event of spillage. Disposal means incineration at high temperatures, not ordinary landfill, to avoid downstream risk. In my time working with cytotoxic raw materials, regular training drills, spill practice, and container tracking prevented incidents. This is not the kind of chemical to leave outside a monitored cabinet or to improvise safety steps. Toxicity warnings and hazard pictograms stay fixed on every package, regardless of shipment size.

Conclusion: Value and Challenges in Chemical Supply

20',20'-Difluoro-3',4'-dihydrovinorelbine Ditartrate stands as a chemical product requiring care, know-how, and strict regulatory compliance. Its properties, structure, and physical form define not only its role in pharmaceutical research but also the safety protocols that surround every gram from synthesis to final use. Molecular tweaks, like difluoro substitution, bring clinical promise but also challenge chemists and logistics teams to maintain purity, density, and stable delivery, an everyday reminder in chemical logistics and pharmaceutical supply. The right mix of technical detail, safe handling, and real-world experience turns a raw material into a viable, life-changing product—one that promises hope on the lab bench and demands responsibility at every step.