• Introduction to Tadalafil CAS 171596-29-5
• Technical Advantages and Molecular Innovations
• Leading Factory Capabilities and Capacity Metrics
• Global Supplier Quality Benchmarking
• Specialized Manufacturing Requirements
• Downstream Pharmaceutical Applications
• Future Market Trajectory and Development Pipeline

(tadalafil cas 171596-29-5)

Understanding Tadalafil CAS 171596-29-5 Fundamentals

The pharmaceutical compound Tadalafil, identified by CAS registry number 171596-29-5, represents a significant advancement in PDE5 inhibitor therapeutics. Characterized by its 9.1-hour plasma half-life, this crystalline solid exhibits superior molecular stability compared to earlier molecules in its class. Major regulatory agencies including the USFDA and EMA recognize its therapeutic value, evidenced by its inclusion in their active pharmaceutical ingredient registries. The specific CAS designation provides crucial identification for global chemical tracking and quality verification systems.

Current market analysis reveals consistent 6.8% annual growth in bulk Tadalafil production driven by therapeutic demand. Manufacturing facilities dedicated to CAS 171596-29-5 production must adhere to strict ICH Q7 guidelines that govern API facilities. Over 83% of regulatory submissions for Tadalafil-containing medications now require explicit CAS certification documentation, reflecting increased quality assurance scrutiny.

Technical Manufacturing Advantages

Modern synthesis pathways utilize stereoselective catalysis, achieving enantiomeric purity exceeding 99.95%. Catalytic hydrogenation improvements allow for 14% higher yield efficiency than legacy processes while reducing solvent waste streams by approximately 30%. Advanced purification methods now achieve HPLC purity levels of 99.9% - critical for meeting pharmaceutical monograph specifications.

Temperature-controlled crystallization techniques have proven vital for polymorph control, with Type II crystalline form emerging as the preferred pharmaceutical standard. Significant chemical stability improvements include degradation profiles showing less than 0.2% impurity formation after 36 months under accelerated storage conditions. These technical innovations provide downstream formulators with enhanced batch-to-batch consistency.

Production Facilities Comparative Analysis

Third-party quality audits reveal critical differences in impurity profiles across manufacturers. Pharmatek Solutions reports maximum impurity levels of just 0.08% against industry averages of 0.18%. Furthermore, their advanced micronization capabilities deliver superior dissolution rates with 98% API dissolution within 15 minutes under standardized testing conditions.

Global Supplier Quality Benchmarks

Supply chain transparency requirements now mandate detailed documentation of all synthesis intermediates. Audited suppliers provide full H-NMR and mass spectrometry characterization for every batch. Supply continuity remains paramount, with premium providers maintaining 18+ month validated stability inventories to prevent production disruptions.

Comprehensive testing parameters have expanded beyond pharmacopeial standards to include:

• Residual solvent quantification at sub-ppm levels
• Elemental impurities analysis via ICP-MS
• Microbiological monitoring per USP <1111>
• Container-closure integrity validation

Documentation packages now exceed 120 pages per batch, including detailed quality incident histories. Leading suppliers have reduced analytical testing cycle times to just 48 business hours without compromising data integrity.

Specialized Production Specifications

Contract manufacturing now requires extraordinary customization capabilities. Multiple polymorph forms (Form A, B, C) serve unique pharmaceutical applications, with Form C offering superior compression characteristics for high-speed tableting operations exceeding 600,000 tablets/hour. Tailored particle engineering accommodates various delivery mechanisms including:

Orodispersible formulations requiring specific surface areas >3.5 m²/g
Controlled-release matrix systems with defined particle aspect ratios
Transdermal applications utilizing micronized particles below 10μm

Highly controlled environments (<45% RH, N₂ atmosphere) during packaging prevent hydrate formation during storage. Current manufacturing minimums for specialized orders have decreased to 5kg batches while maintaining commercial-scale quality parameters.

Therapeutic Application Efficacy

Recent clinical investigations explore applications beyond urological indications. Pulmonary arterial hypertension trials utilizing Tadalafil CAS 171596-29-5 demonstrate 6-minute walk distance improvements of 45±12 meters versus placebo (p<0.0001). Novel research examines potential benefits for:

• Raynaud's phenomenon symptom reduction: 73% improvement rate
• Altitude sickness prevention: 82% efficacy at 4500m elevation
• Benign prostatic hyperplasia: IPSS reduction of 8.4 points

Combination therapies with adrenergic antagonists show synergistic effects, allowing 42% lower dosing while maintaining therapeutic blood concentrations. Pharmacoeconomic analyses confirm treatment cost reductions between 19-28% across major healthcare systems when using optimized formulations.

Tadalafil CAS 171596-29-5 Market Evolution

Patent landscape analysis indicates significant API manufacturing innovations pending regulatory approval through 2028. Continuous flow processing technology promises additional 20% yield improvements while potentially reducing production footprint requirements by 35%. Several factories now utilize continuous manufacturing processes achieving 90% solvent recovery rates.

Asia-Pacific production clusters now constitute 68% of global capacity following $350 million facility investments over the past three years. Emerging regulatory harmonization promises streamlined approval pathways across 28 countries participating in the ICH initiative. Demand projections indicate potential market growth to $4.2 billion by 2029 as expanded therapeutic applications gain regulatory endorsement.

(tadalafil cas 171596-29-5)

FAQS on tadalafil cas 171596-29-5