(S)-Alpha,Alpha-Diphenyl-3-Pyrrolidineacetamide-L-tartrate, known as Darifenacin, stands out as a highly specialized compound in medical and chemical industries. Its reputation comes from its value in pharmaceutical formulations, mainly in managing overactive bladder symptoms. The name itself hints at a blend of chirality, aromatic rings, and complex organic structuring. Experience in handling such compounds often arrives in research labs where understanding fine chemical differences spells out product effectiveness.
Darifenacin’s molecular structure packs a punch with two large phenyl groups, a pyrrolidine ring, and attachment to the tartaric acid counterion. This arrangement, featuring stereospecific positions, means it resists many metabolic changes, demonstrating stability. Chemically, the formula reads C28H33NO7, driven by the unique presence of both aromaticity and chirality. The substance typically comes as a solid: off-white or pale yellow flakes, sometimes forming fine powder or small crystalline grains. Researchers often look for density readings hovering close to 1.24 g/cm³, which helps separate it physically from other inactive bulk excipients.
In the pharmaceutical world, Darifenacin turns into extended-release tablets or capsules. Its main role targets the muscarinic M3 receptor, which makes it effective for patients dealing with urinary urgency and frequency. Hospitals and pharmacies recognize it regularly under branded names. For anyone working in chemical supply, raw materials for Darifenacin often come in sealed, opaque containers to prevent both moisture and photodegradation. The material’s solid form, whether as pearl-like granules or fine powder, requires careful weighing due to its chemical potency. Under normal laboratory conditions, it stays stable; any contact with acid, strong alkali, or excessive humidity can begin decomposition. Those tasked with formulation must account for its moderate solubility in water, higher affinity for organic solvents, and safe storage below standard laboratory temperatures.
Darifenacin’s physical traits show how nuanced chemical identity can get. Its flakes or crystalline powder stick to a specific melting point, typically registering between 151°C and 155°C, making impurity detection straightforward. Moisture content stays low, below 1.5% in raw batches, guaranteeing less breakdown during manufacturing. The compound dissolves better in ethanol and acetone than in water, showing how pharmaceutical engineers must design delivery routes that maximize absorption in the human gut. From direct experience, static charge can build up in dry climates, so antistatic surfaces and tools stay essential in production spaces.
Darifenacin’s crystalline forms can be hygroscopic, drawing water from ambient air. This trait pushes storage in desiccant-packed vials. Material comes clearly labeled with the HS Code 2933399090, sorting it with organic nitrogen compounds. Landed shipments need chemical verification for identity and purity, using methods like NMR or HPLC, since even small error margins reduce its clinical effect and could raise toxicity.
Each molecule of Darifenacin’s L-tartrate displays defined stereochemistry. The S-enantiomer demonstrates maximum biological activity, most apparent in in vitro receptor-binding trials. Reputable suppliers present full spectral data, confirming three-dimensional organization, and batch specifications highlight clarity, absence of visible contamination, and assay purity not dropping below 98%.
Density checks usually sit at 1.24 g/cm³, so packaging managers plan drum or bottle labels with this in mind. Powder forms compress readily but resist caking if handled right. As a solid, flowability rates as good in standard granulators, while some operations elect to process it as a slurry in chilled, controlled atmospheres. Flakes or pearls, often generated post-recrystallization, can simplify scaling for pilot or commercial runs without significant loss during transfers.
Darifenacin, like many high-potency pharmaceutical compounds, brings both benefits and hazards. In the raw form, dust or fine powder calls for gloves, goggles, and, in some cases, a respirator due to its possible skin and mucous membrane irritation. Strong chemical safety training helps reduce the risk of accidental exposure. Material safety data recommends room-temperature storage away from strong acids and bases. Spills require HEPA-filtered vacuums, not broom sweeping. Inhalation, ingestion, or inappropriate contact could introduce harmful side effects. Waste disposal follows local and national hazardous chemical rules, often classified under organic pharmaceutical waste.
Commercial shipping and labeling stick to strict rules. The HS Code 293399090 slots it as an organic nitrogen compound, ensuring customs officials and handlers treat it with due caution. Each container features hazard pictograms, and manufacturing zones limit direct access to trained personnel, minimizing workplace incidents.
Raw materials for Darifenacin synthesis span multiple chemical intermediates: aromatic benzene derivatives, pyrrolidine intermediates, and tartaric acid. Reliable supply chains make all the difference here. Tartaric acid ensures salt formation, improving stability and bioavailability. Every batch receives testing for heavy metals, residual solvents, and microbial load, so downstream pharmaceutical use passes regulatory inspection. Most active pharmaceutical ingredient (API) manufacturers keep strict documentation to trace every gram from origin to finished tablet, recognizing the hard lessons learned across decades of regulatory oversight.
Choices in sourcing affect final cost, quality, and sustainability. Preference keeps swinging toward greener synthetic steps, using solvents and reagents less likely to pollute or risk health. Transparent supply partnerships cut down the chance of adulterants, especially for minor but crucial excipients. Finished Darifenacin salt, whether used in research lots or mass-market formulation, owes its reliability to upstream quality and attention to both purity and process safety.
Molecularly, Darifenacin combines hydrophobic and hydrophilic domains, which shapes interactions within delivery vehicles. Its formula, C28H33NO7, reflects the presence of multiple aromatic rings and polar groups, contributing to balanced solubility. Each batch undergoes quantitative purity checks, identified by precise melting points and consistent NMR peaks.
In daily laboratory and production use, staff encounter powder forms most often. In high-humidity regions, material readily absorbs water, turning sticky over time. Proper material management keeps inventory fresh and compliant with the strict shelf life demands attached to pharmaceutical ingredients. Some researchers tested new packaging designs, such as single-use ampules, to limit unnecessary exposure and cross-contamination. Large plants often opt for bulk solid dosing systems, cutting down operator contact and improving occupational safety records.
Darifenacin matters in the world of therapeutics for those living with bladder dysfunction. Chemical reliability in manufacturing underpins these benefits. Product recalls from contaminant presence show that even minor lapses leave real-world health impacts. Simple design changes in facility layout, air handling, and operator training bring higher compliance. Enhanced automation, better real-time analytical controls, and transparent reporting around raw material origin all drive future improvements in this sector. For end users, packaging that carries concise instructions, clear hazard pictograms, and emergency handling numbers makes a difference.
From raw chemical lot to finished product, everything boils down to accuracy, purity, and a culture of safety. Molecules like Darifenacin remind everyone involved—from bench scientists to plant operators—how much small details matter in chemical production. Future steps toward even safer, more sustainable synthesis pay off for both industry and patients.
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