Sildenafil Citrate

Sildenafil Citrate is a selective phosphodiesterase type 5 (PDE5) inhibitor supplied as a high-purity white to off-white crystalline powder, manufactured via validated organic synthesis routes and optimized for downstream oral solid dosage formulation.

Molecular Identity: C22H30N6O4S * C6H8O7, molecular weight of 666.70 g/mol, verified CAS registry number 171599-83-0.

Solubility Parameters: Slightly soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol and anhydrous ether.

Crystalline Habit: Exhibits a sharp melting range between 187°C and 192°C with consistent Form I crystal lattice confirmed via XRPD.

Aqueous pH Profile: Maintains a stable 3.5 to 4.5 pH range in a 1% aqueous solution at 25°C.

Impurities Control: Monitored against stringent pharmacopeial monographs, keeping specified related substances below the 0.10% threshold.

Particle Size Distribution: Controlled via jet-milling parameters to achieve a targeted $D_{90}$ of less than 15 micrometers for optimal powder flow.

Stability Kinetics: Long-term data confirms stability under ICH climatic zone IVb conditions (30°C / 65% RH) for 36 months.

Compression Compatibility: Fully compatible with standard excipients including microcrystalline cellulose, lactose monohydrate, and croscarmellose sodium.

Hygroscopic Behavior: Demonstrates non-hygroscopic properties under standard ambient manufacturing environments, preventing hopper caking.

Dissolution Performance: Micronized structure promotes rapid disintegration matching reference listed drug dissolution profiles across pH 1.2, 4.5, and 6.8 media.

Excipient Interaction: Displays zero chemical incompatibility during accelerated forced degradation studies.

Prescription Tablets: Active pharmaceutical ingredient for standard oral film-coated tablets ranging from 25 mg to 100 mg strengths.

Orally Disintegrating Systems: Fine particle grade utilized in fast-melting formulations requiring rapid active substance dispersion.

Clinical R&D: Reference-grade material utilized by generic drug manufacturers for bioequivalence and pharmacokinetic evaluations.

Chromatographic Purity: Tested through gradient elution HPLC equipped with diode array detection to quantify degradation products.

Microbial Limits: Assayed for total aerobic count, yeasts, molds, and specific pathogen absence per harmonized guidelines.

Batch Traceability: Full electronic batch records maintained from starting material synthesis to final sealing for audit readiness.

Regulatory Dossiers: Comprehensive Drug Master File (DMF) available for cross-reference supporting regulatory filings.

Analytical Documentation: Each commercial shipment includes an original Certificate of Analysis (COA) detailing all instrumental test outcomes.

Supply Chain Transparency: Complete supply chain mapping available for raw material origin verification and adherence to ICH Q7 guidelines.

Temperature Control: Store tightly closed in a cool, dry, and well-ventilated area, maintaining ambient storage between 15°C and 25°C.

Light Protection: Stored within double polyethylene liners housed inside fiber drums to prevent ultraviolet radiation exposure.

Shelf Life: Verified 36-month shelf life from the manufacturing date when unopened under recommended parameters.

Primary Packaging: Food-grade, double-layer low-density polyethylene bags heat-sealed under nitrogen purge to eliminate residual oxygen.

Secondary Packaging: Rigid moisture-resistant fiber drums secured with tamper-evident locking rings and external safety seals.

Unit Configuration: Standard 25 kg net weight drum configurations, with custom packaging increments available upon agreement.

Minimum Order Quantity (MOQ): Standard commercial MOQ starts at 25 kg (1 standard drum); pilot/evaluation quantities available upon formal request.

Transport Conditions: Shipped via temperature-monitored freight carriers under non-hazardous chemical classification rules.

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