Mirtazapine Powder (CAS 85650-52-8)
Product Name: Mirtazapine Powder
CAS Number: 85650-52-8
Synonyms: ORG-3770, 6-Azamianserin, Org 5222
Molecular Formula: C₁₇H₁₉N₃
Molecular Weight: 265.35
1. Product Description
Mirtazapine is a potent, tetracyclic antidepressant belonging to the piperazino-azepine class of compounds. It is a noradrenergic and specific serotonergic antidepressant (NaSSA), chemically designated as 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine.
Our Mirtazapine Powder presents as a white to off-white crystalline powder, slightly soluble in water, and freely soluble in organic solvents like methanol and chloroform. It is manufactured as a racemic mixture under strict GMP conditions to ensure exceptional purity and consistency.
2. Key Specifications & Quality Standards
| Item |
Specification |
| Assay (HPLC) |
≥98.0% |
| Appearance |
White to off-white crystalline powder |
| Melting Point |
114°C – 116°C |
| Loss on Drying |
≤0.5% |
| Residue on Ignition |
≤0.1% |
| Heavy Metals |
≤10 ppm |
| Particle Size |
95% through 200 mesh |
| Microbiological Purity |
Total plate count <1000 CFU/g; Yeast & Mold <100 CFU/g |
3. Mechanism of Action
Mirtazapine exerts its therapeutic effects through a unique dual mechanism:
- Blocks α₂-adrenergic receptors: Enhances the release of norepinephrine and serotonin in the brain.
- Selectively antagonizes 5-HT₂ and 5-HT₃ receptors: Promotes specific serotonergic activity, minimizing common side effects associated with other antidepressants.
- Potent H₁ histamine receptor antagonist: Contributes to its anxiolytic and sedative properties, which are beneficial for patients with concurrent insomnia.
4. Primary Applications
- Pharmaceutical Raw Material: For the formulation of oral tablets, orally disintegrating tablets, and other finished dosage forms.
- Research & Development: For pharmacological studies, in vitro assays, and novel delivery research.
- Veterinary Use: As an appetite stimulant and anti-emetic in companion animals (under veterinary supervision).
5. Advantages of Our Product
- Superior Purity: HPLC ≥98.0%, minimizing impurities and ensuring patient safety.
- Stable Quality: Strict process control and comprehensive quality testing for every batch.
- Secure Packaging: Available in 1kg, 5kg, 25kg fiber drums with PE liners to preserve integrity during storage and shipping.
- Global Compliance: Manufactured in compliance with ICH Q7 guidelines and ready for regulatory filings (DMF available on request).
- Technical Support: Experienced R&D team provides comprehensive documentation (COA, MSDS, HPLC, NMR).
6. Storage & Handling
- Storage Conditions: Store in a cool, dry place, protected from light and moisture. Recommended temperature: 15°C – 25°C.
- Shelf Life: 2 years under proper storage conditions.
- Handling: Use in a well-ventilated area. Wear protective gloves, clothing, and eye/face protection. Avoid inhalation and contact with skin or eyes.
7. Safety & Regulatory Information
- Legal Status: Prescription Only (POM) in most jurisdictions. For industrial/manufacturing use only. Not for direct human consumption.
- UN Number: Not classified as a dangerous good for transport.
- MSDS: Available upon request for full safety details.
8. Packaging & Shipping
- Standard Packing: 25kg / Fiber Drum
- Small Packing: 1kg, 5kg / Aluminum Foil Bag
- Lead Time: In stock – Shipped within 3 working days.
- Shipping: By sea, air, or international courier (DHL, FedEx, UPS).
Why Choose Us?
We are a leading manufacturer and supplier of high-quality API (Active Pharmaceutical Ingredients) with a focus on the global pharmaceutical market. Our Mirtazapine Powder is produced in a state-of-the-art facility, guaranteeing unmatched purity, stability, and reliability. We offer
competitive pricing,
flexible MOQs, and
professional after-sales service to support your business success.
Contact us today for a quote, free sample, or more technical information.