AMITRIPTYLINE HYDROCHLORIDE

Amitriptyline Hydrochloride is a tricyclic antidepressant (TCA) widely used in the treatment of major depressive disorder, neuropathic pain, and certain anxiety disorders. It works by inhibiting the reuptake of norepinephrine and serotonin, increasing their concentration in the synaptic cleft and enhancing neurotransmission, which improves mood, sleep, and overall mental well-being.

At Bluepill Express, we manufacture and export pharmaceutical-grade Amitriptyline Hydrochloride API that complies with IP, BP, USP, and EP pharmacopeial standards. Produced under WHO-GMP, ISO, and cGMP-certified facilities, our API ensures high purity, consistent particle size, and superior stability, suitable for tablets, capsules, and oral solutions.

Each batch undergoes rigorous quality testing, including HPLC, IR spectroscopy, and microbial analysis, ensuring reliable performance for global pharmaceutical manufacturers.

Pharmacological Information:

• Therapeutic Class: Antidepressant / Tricyclic Antidepressant (TCA)
• Pharmacological Category: Norepinephrine & Serotonin Reuptake Inhibitor
• CAS Number: 50-48-6
• Molecular Formula: C20H23N·HCl
• Molecular Weight: 313.87 g/mol
• Appearance: White to off-white crystalline powder
• Solubility: Soluble in water, ethanol, and methanol
• Melting Point: 195°C – 198°C
• Storage: Store in a cool, dry place below 25°C, protected from light

Mode of Action:

Amitriptyline Hydrochloride blocks the reuptake of norepinephrine and serotonin at presynaptic neurons, enhancing their availability in the central nervous system. This modulates mood, improves sleep quality, reduces anxiety, and alleviates neuropathic pain.

Applications and Uses:

• Major Depressive Disorder (MDD) – First-line TCA therapy for mood improvement
• Neuropathic Pain – Effective in diabetic neuropathy, postherpetic neuralgia
• Anxiety Disorders – Reduces generalized anxiety and panic symptoms
• Migraine Prophylaxis (off-label) – Reduces frequency of migraine attacks
• Pharmaceutical Formulations – Tablets, capsules, oral solutions, and combination products

Technical Specifications:

• Assay (Purity): ≥ 99.0%
• Identification: IR spectrum matches reference standard
• Loss on Drying: ≤ 0.5%
• Residue on Ignition: ≤ 0.1%
• Heavy Metals: ≤ 10 ppm
• Related Substances: ≤ 0.2% (individual impurity)
• Particle Size: Optimized for uniform formulation
• Microbial Limits: Complies with pharmacopeial standards

Manufacturing & Quality Assurance – Bluepill Express:

• Manufactured under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities
• High-purity crystalline API suitable for various oral dosage forms
• COA, MSDS, and TDS provided for each batch
• HPLC-tested for purity and impurity profiling
• Pharmacopeial compliance: IP / BP / USP / EP

Packaging & Export Details:

• Available Packs: 1 kg, 5 kg, 10 kg, 25 kg HDPE drums with inner liner
• Shelf Life: 36 months from manufacturing date
• Labeling: Export-compliant with batch number and origin
• Export Markets: Africa, Asia, Europe, Middle East, Latin America
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Technical Data Sheet (TDS)
  • Stability Data (on request)
  • Non-GMO & Allergen-Free Declarations