Dapoxetine Hydrochloride is a selective serotonin reuptake inhibitor synthesized as a high-purity active pharmaceutical ingredient for solid oral dosage manufacturing. Optimized via advanced crystallization and controlled purification pathways, this API delivers consistent assay values, defined particle morphology, and rigorous control over impurity profiles to support reproducible downstream processing, regulatory compliance, and scalable commercial production.
Key Specifications
|
Parameter |
Specification Standard |
Test Method / Note |
|
CAS Registry Number |
129938-20-1 |
Chemical Identity |
|
Molecular Formula |
C21H24FNO * HCl |
Stoichiometric Formula |
|
Molecular Weight |
357.89 g/mol |
Mass per Mole |
|
Appearance |
White to off-white crystalline powder |
Visual Inspection |
|
Assay (Dried Basis) |
99.0% to 101.0% |
HPLC |
|
Water Content |
Less than or equal to 0.5% |
Karl Fischer |
|
Residue on Ignition |
Less than or equal to 0.1% |
Pharmacopeial Standard |
|
Specified Impurity |
Less than or equal to 0.10% |
Individual Maximum |
|
Unspecified Impurity |
Less than or equal to 0.05% |
Individual Maximum |
|
Total Impurities |
Less than or equal to 0.30% |
Cumulative Limit |
|
Residual Solvents |
ICH Q3C Compliant (Ethanol less than or equal to 5000 ppm, Dichloromethane less than or equal to 600 ppm) |
GC Headspace |
Chemical & Functional Characteristics
Solubility & Phase Behavior
Freely soluble in methanol and ethanol; sparingly soluble in water, influencing binder selection and wet granulation strategies.
Polymorphism & Stability
Single, stable polymorphic form manufactured via validated crystallization parameters to prevent phase transformation during storage and compression.
Hygroscopic Performance
Low moisture affinity under ambient conditions, preventing caking and maintaining mass constancy during high-speed blending.
Technical Focus & Critical Parameters
Particle Size Distribution (PSD)
Precision jet-milled to achieve D10 less than or equal to 5 micrometers, D50 between 15 and 25 micrometers, and D90 less than or equal to 60 micrometers for optimized powder flow and content uniformity.
Chiral Integrity
Synthesized via stereoselective pathways ensuring high enantiomeric excess and strict pharmacological fidelity.
Elemental Impurity Control
Quantified via ICP-MS under ICH Q3D guidelines, keeping heavy metals safely below toxicological thresholds.
Formulation & Process Integration
Direct Compression Suitability
Optimized crystal habit reduces glidant demand while supporting stable tablet hardness and rapid disintegration.
Excipient Compatibility
Inert interaction profile with standard excipients including microcrystalline cellulose, lactose monohydrate, and magnesium stearate.
Dissolution Optimization
Tailored particle sizing supports immediate-release profiles for consistent in-vivo bioavailability.
Commercial Applications
Immediate-Release Tablets
Primary active ingredient for core oral tablets engineered for fast gastrointestinal absorption.
Clinical Trial Materials
Supplied in phase-appropriate batch sizes for bioequivalence and stability protocol validation.
Combination Drug Research
Validated active component for advanced urological development initiatives.
Quality Assurance & Testing
Analytical Methodologies
Released using validated HPLC, GC-MS, LC-MS/MS, and FTIR procedures.
In-Process Monitoring
Real-time tracking of reaction kinetics, thermal gradients, and centrifugation parameters.
Reference Traceability
Calibrated against primary pharmacopeial standards to ensure absolute data integrity.
Technical Documentation & Regulatory Support
Comprehensive Dossier Deliverables
Supplied with complete technical data packages containing Certificates of Analysis for registration, pilot, and commercial validation batches.
Safety & Analytical Protocols
Includes fully compliant GHS-standard Safety Data Sheets alongside detailed Product Specifications, Analytical Methods, and Synthesis Routes.
Regulatory Compliance Declarations
Backed by formal BSE/TSE-Free certificates, Non-GMO statements, and comprehensive allergen documentation.
Global Regulatory Support
Full coordination for Drug Master Files and Certificate of Suitability requirements to support filings with major international health authorities.
Storage & Stability Protocol
Temperature Control
Store between 15 degrees Celsius and 25 degrees Celsius, with permissible excursions up to 30 degrees Celsius.
Environmental Protection
Sealed in moisture-resistant containers protected from direct light and humidity.
Shelf Life
36-month re-test window established from the date of manufacture in unopened original packaging.
Packaging & Logistics
Primary Containment
Double-layer food-grade LDPE bags heat-sealed under nitrogen purge to eliminate oxidation.
Secondary Protection
High-density fiber drums featuring tamper-evident seals to prevent mechanical and light exposure.
Transit Security
Shipped under secured, climate-monitored ambient logistics channels.
Frequently Asked Questions
Q: What is the standard commercial order quantity?
A: Supplied in 25 kg fiber drum configurations, with custom bulk packaging available.
Q: Are validated test methods provided for lab verification?
A: HPLC test protocols and chromatograms are included in the documentation package.
Q: How are residual solvents managed?
A: Synthetic routes use Class 3 or controlled Class 2 solvents verified via headspace GC.
Q: What is the standard replenishment lead time?
A: Routine orders ship within 10 to 15 business days following technical confirmation.
Q: Can particle size distribution be customized?
A: Yes, custom jet-milling parameters can be applied to meet specific compression profiles.
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