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Duloxetine Hydrochloride API is a potent antidepressant belonging to the serotonin-norepinephrine reuptake inhibitor (SNRI) class. It is widely prescribed for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain.
At Bluepill Express, we manufacture Duloxetine Hydrochloride API using advanced synthesis technology under strict WHO-GMP, ISO 9001:2015, and cGMP guidelines. Each batch undergoes rigorous quality control testing to ensure high purity, precise assay, and consistent particle size — making it suitable for tablet, capsule, and extended-release formulations.
Duloxetine Hydrochloride enhances mood and relieves pain by inhibiting the reuptake of serotonin and norepinephrine in the central nervous system, restoring the balance of neurotransmitters associated with mood regulation and nerve pain perception.
Our API meets USP / EP / BP / IP pharmacopoeial standards and is available with complete documentation support — COA, MSDS, and DMF. Bluepill Express is globally recognized for its quality-driven API manufacturing and timely export services.
Therapeutic Applications:
- Major Depressive Disorder (MDD)
- Generalized Anxiety Disorder (GAD)
- Diabetic Peripheral Neuropathic Pain
- Fibromyalgia and Chronic Pain Syndromes
- Chronic Musculoskeletal and Low Back Pain
Mechanism of Action:
Duloxetine Hydrochloride works as a dual reuptake inhibitor of serotonin (5-HT) and norepinephrine (NE). By blocking their reabsorption into presynaptic neurons, it increases their availability in the synaptic cleft, enhancing neurotransmission and mood regulation.
Additionally, its analgesic effect is due to the modulation of descending pain pathways in the spinal cord, which helps alleviate neuropathic and chronic pain conditions.
Technical Specifications:
- Chemical Name: Duloxetine Hydrochloride
- Molecular Formula: C₁₈H₁₉NOS·HCl
- Molecular Weight: 333.87 g/mol
- CAS Number: 136434-34-9
- Description: White to slightly brown crystalline powder
- Assay (on dried basis): NLT 98.0%
- Melting Point: 170°C – 175°C
- Solubility: Soluble in methanol and ethanol; slightly soluble in water
- Optical Rotation: +50° to +58°
- Storage: Store in a tightly closed container below 25°C, protected from light and moisture
Pharmacological Classification:
- Therapeutic Class: Antidepressant / SNRI (Serotonin-Norepinephrine Reuptake Inhibitor)
- Pharmacopoeial Standards: USP / BP / IP / EP
- Dosage Form Applications:
- Tablets (20 mg, 30 mg, 60 mg)
- Capsules (Delayed/Extended Release)
Manufacturing & Quality Standards – Bluepill Express:
- Manufactured under WHO-GMP, ISO, and cGMP certifications
- Meets USP/BP/IP/EP quality and purity standards
- Controlled particle size for improved solubility and stability
- Advanced analytical validation via HPLC and UV spectrophotometry
- Supplied with full regulatory documentation (COA, MSDS, DMF)
- Complies with ICH Q7 and FDA guidelines for API production
Advantages of Bluepill Express Duloxetine Hydrochloride API:
- High assay and low impurity profile
- Global regulatory and pharmacopoeial compliance
- Available in bulk quantities for international export
- Custom packaging and labeling per regional standards
- Technical and formulation support for manufacturers
Packaging & Export Information:
- Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE container with double LDPE liner
- Labeling: In compliance with international export norms
- Shelf Life: 3 years under recommended storage conditions
- Export Regions: Africa, Middle East, Asia-Pacific, Europe, and Latin America
- Documents Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Drug Master File (DMF) – on request
- BSE/TSE & Non-GMO Declarations
