Duloxetine Hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) supplied as a bulk active pharmaceutical ingredient for secondary pharmaceutical processing. Synthesized via stereoselective routes to ensure high enantiomeric purity, the substance functions as the active pharmaceutical constituent in oral solid dosage forms targeting central nervous system disorders. Production adheres strictly to current Good Manufacturing Practice (cGMP) standards, ensuring strict control over chiral purity, residual solvents, and elemental impurities to meet global pharmacopeial requirements.
Product Information
|
Parameter |
Specification Details |
|
International Nonproprietary Name (INN) |
Duloxetine Hydrochloride |
|
Chemical Name |
(3S)-N-methyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propan-1-amine hydrochloride |
|
CAS Registry Number |
136434-34-9 |
|
Molecular Formula |
C18H20ClNOS |
|
Molecular Weight |
333.88 g/mol |
|
Structural Formula |
Organic salt containing naphthalene and thiophene rings |
|
Therapeutic Category |
Antidepressant / Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) |
Quality & Specification
|
Test Parameter |
Acceptance Criteria (USP / EP / BP) |
Analytical Method |
|
Appearance |
White to off-white solid |
Visual Inspection |
|
Identification (IR / HPLC) |
Conforms to reference standard |
Infrared Absorption / HPLC |
|
Assay (Calculated on dried basis) |
99.0% – 101.0% |
High-Performance Liquid Chromatography (HPLC) |
|
Chiral Purity (Enantiomeric Excess) |
Single enantiomer, $\ge 99.5\%$ |
Chiral HPLC |
|
Loss on Drying |
$\le 0.5\%$ |
Gravimetric Analysis $\left(105^\circ\text{C}\right)$ |
|
Residue on Ignition |
$\le 0.1\%$ |
Platinum Crucible Incineration |
|
Heavy Metals |
$\le 10\text{ ppm}$ |
Inductively Coupled Plasma Mass Spectrometry (ICP-MS) |
|
Individual Unknown Impurity |
$\le 0.10\%$ |
Gradient HPLC |
|
Total Impurities |
$\le 0.5\%$ |
Gradient HPLC |
|
Residual Solvents (Class 2 / 3) |
Complies with ICH Q3C limits |
Headspace Gas Chromatography (HS-GC) |
Manufacturing & Supply
|
Operational Parameter |
Technical Standard / Control Measure |
|
Production Scale |
Commercial multi-ton manufacturing capacity with dedicated reaction trains |
|
Synthesis Route |
Advanced chiral reduction followed by salt formation, minimizing toxic intermediates |
|
Cleanroom Classification |
ISO Class 8 (D Grade) cleanrooms for crystallization, isolation, and drying |
|
Containment Systems |
Closed-system filtration and vacuum drying to prevent cross-contamination and moisture exposure |
|
In-Process Controls (IPCs) |
Real-time temperature, pressure, and pH logging during chemical synthesis stages |
|
Batch Size & Traceability |
Standardized commercial batch sizes with full raw material backward traceability |
Documentation
|
Regulatory Document Type |
Availability & Scope |
|
Drug Master File (DMF) |
Open/Closed part DMF available for regulatory submission across multiple jurisdictions |
|
Certificate of Analysis (CoA) |
Provided with every commercial batch, detailing full analytical testing results |
|
Certificate of Suitability (CEP) |
Available upon request for European regulatory filings |
|
ICH Q3D Elemental Impurities Report |
Complete risk assessment and batch testing data package |
|
ICH Q3C Residual Solvents Declaration |
Certified compliance statement verifying absence of prohibited solvents |
|
TSE/BSE Statement |
Guaranteed free from animal-derived raw materials |
|
Genotoxic Impurity Assessment |
Comprehensive toxicological evaluation and routine screening data |
Packaging
|
Packaging Layer |
Material Specification & Protection |
|
Primary Packaging |
Food-grade double low-density polyethylene (LDPE) bags, heat-sealed under inert nitrogen purge |
|
Secondary Packaging |
Moisture-barrier aluminum foil liner bag safeguarding against humidity and air exposure |
|
Outer Packaging |
Rigid fiber drum or UN-certified corrugated cardboard box with tamper-evident seals |
|
Standard Batch Quantity |
25 kg net weight per drum (customizable packaging sizes available for clinical or commercial scale) |
|
Storage Conditions |
Store below 25℃, protected from direct light and atmospheric moisture |
Pharmaceutical Application
Major Depressive Disorder (MDD): Formulated into solid oral delayed-release capsules to manage acute and maintenance phases of major depressive episodes. Restores neurotransmitter balance within central synaptic clefts.
Generalized Anxiety Disorder (GAD): Used as the active pharmaceutical ingredient for chronic anxiety management formulations. Alleviates persistent psychological tension and somatic symptoms.
Diabetic Peripheral Neuropathic Pain (DPNP): Applied in neuro-pathic pain attenuation medications targeting persistent peripheral nerve discomfort. Modulates descending inhibitory pain pathways in the central nervous system.
Fibromyalgia Management: Utilized in multi-symptom chronic pain treatment regimens. Reduces widespread musculoskeletal pain intensity and improves patient physical functioning scores.
FAQ
Q: What is the standard commercial batch size for Duloxetine Hydrochloride?
A: Standard commercial production runs yield uniform lots packaged at 25 kg net weight per fiber drum, with custom packaging configurations accessible upon formal agreement.
Q: Is a Drug Master File (DMF) accessible for regulatory review?
A: Yes, a comprehensive Drug Master File is maintained and available for cross-referencing to support abbreviated new drug applications (ANDAs) and marketing authorizations.
Q: How is chiral purity verified during batch release?
A: Chiral high-performance liquid chromatography (HPLC) is employed on every production lot to guarantee enantiomeric excess above 99.5% and prevent optical isomer contamination.
Q: What storage conditions are required to maintain stability?
A: The material must be stored in airtight containers below 25°C, protected from direct light and high humidity, supported by real-time and accelerated stability study data.
Q: Are genotoxic impurities routinely tested in finished lots?
A: Yes, sensitive analytical methods such as LC-MS/MS are utilized to screen and quantify potential process-related impurities in compliance with ICH M7 guidelines.
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