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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).
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.
Company Details
Bronze Gleitlager
,
Bronze Sleeve Bushings
and
Graphite Plugged Bushings
from Quality China Factory
Business Type:
Manufacturer,Distributor/Wholesaler,Exporter
Year Established:
2016
Total Annual:
5000000-6000000
Employee Number:
50~100
Ecer Certification：
Verified Supplier
About Us
Founded in Fangshan District, Beijing, Bovita is a forward-thinking biotech startup specializing in high-purity peptide products and premium dietary supplement raw materials. Rooted in the rigorous standards of China’s pharmaceutical and chemical industry, we are dedicated to b...
About Us
Founded in Fangshan District, Beijing, Bovita is a forward-thinking biotech startup specializing in high-purity peptide products and premium dietary supplement raw materials. Rooted in the rigorous standards of China’s pharmaceutical and chemical industry, we are dedicated to b...
