Mirtazapine — API | CAS 85650-52-8

TCS Industries Limited (China-sourced API supplier) supplies Mirtazapine — API CAS 85650-52-8 for pharmaceutical B2B procurement — COA, MSDS, and technical documentation available on request.

> Overview

Product Name Mirtazapine
Structural Formula Mirtazapine CAS 85650-52-8 structural formula
CAS Number 85650-52-8
Molecular Formula C₁₇H₁₉N₃
Molecular Weight 265.35 g/mol
InChIKey RONZAEMNMFQXRA-UHFFFAOYSA-N
SMILES Available on request where applicable
Appearance White to off-white crystalline powder
Purity / Grade By agreed specification and batch COA
Storage Room temperature, protect from light and moisture

Mirtazapine (CAS 85650-52-8) is a noradrenergic and specific serotonergic antidepressant (NaSSA) with the formula C₁₇H₁₉N₃ (MW 265.35). It enhances noradrenergic and serotonergic neurotransmission by blocking α₂-adrenergic autoreceptors and heteroreceptors, and selectively antagonizes 5-HT₂ and 5-HT₃ serotonin receptors. Mirtazapine is used for major depressive disorder, particularly with insomnia and appetite loss.

TCS Industries Limited, a Hong Kong-based trading and sourcing company, supplies Mirtazapine API in pharmaceutical grade for global procurement programs.

> Applications

Antidepressant with sedative properties

Mirtazapine 15–45 mg once daily at bedtime is used for major depressive disorder. Its dual mechanism (α₂ blockade + 5-HT₂/5-HT₃ antagonism) provides antidepressant, anxiolytic, sedative, and appetite-stimulating effects. Paradoxically, it is more sedating at 15 mg than at 45 mg due to antihistamine (H₁) receptor blockade that is overcome by noradrenergic activation at higher doses. De Boer et al. (J Clin Psychiatry, 1996, 57 Suppl 4:19–25) described the pharmacological profile of mirtazapine and its unique mechanism of action as a NaSSA antidepressant.

Off-label uses

Mirtazapine is used off-label for insomnia, appetite stimulation in cancer cachexia, PTSD-related nightmares, nausea (5-HT₃ antagonism), and as augmentation strategy in treatment-resistant depression. Its 5-HT₃ antagonism provides antiemetic properties similar to ondansetron.

> Sourcing & Supply

TCS Industries Limited supports development, qualification and commercial purchasing discussions for Mirtazapine with buyers in Australia, New Zealand, Canada and South Korea.

  • Evaluation and commercial quantities: 500 g samples for formulation development; 5 kg and 25 kg for production. Pharmaceutical (USP/Ph.Eur.) grade crystalline powder. DMF reference letters available.
  • Pallet quantities and production campaigns: repeat supply is coordinated against packaging, lead time, annual demand and destination-market import requirements.

> Quality & Documentation

Key specification parameters include assay (≥99.0%), related substances (individual ≤0.15%, total ≤0.5%), loss on drying, residual solvents, heavy metals, particle size distribution, and microbial limits. White to off-white crystalline powder. Slightly soluble in water, soluble in methanol. Identity by HPLC and IR. Meets USP (Mirtazapine) and Ph.Eur. (Mirtazapinum). COA and MSDS are standard.

> Packaging

Mirtazapine is a white to off-white crystalline powder. Standard packaging includes double PE-lined foil bags in fibre drums (1 kg, 5 kg, or 25 kg). Store at controlled room temperature (15–25 °C). Protect from light and moisture. Shelf life is typically 36 months. Labels and documents are checked before dispatch.

> Pricing & MOQ

Pricing is quoted by specification, packaging and destination. Common commercial discussions use 25 kg bag/drum formats, pallet quantities and production-campaign planning; smaller samples may be reviewed for qualified formulation teams.

> Regulatory & Compounding Context

Mirtazapine is monographed in USP and Ph.Eur. FDA-approved in 1996 (Remeron). EMA-authorized. Off-patent with multiple generic approvals. Orally disintegrating tablet (Remeron SolTab) also approved. DMF support available from qualified manufacturers.

> Alias Index

  • INN: Mirtazapine
  • CAS Number: 85650-52-8
  • Formula: C₁₇H₁₉N₃ (MW 265.35)
  • Brand name: Remeron (Organon/Merck)
  • ATC code: N06AX11
  • Pharmacological class: NaSSA (noradrenergic and specific serotonergic antidepressant)
  • Commercial request terms: mirtazapine API, Remeron generic, NaSSA antidepressant, sedating antidepressant API, TCS Industries Limited

> FAQ

Why is Mirtazapine more sedating at lower doses?

At 15 mg, mirtazapine primarily blocks H₁ histamine receptors (sedation) and 5-HT₂ receptors. At 30–45 mg, additional noradrenergic activation (from α₂ blockade) counteracts the H₁ sedation. This dose-dependent shift in receptor occupancy profile creates the paradox of less sedation at higher doses. Start at 15 mg for insomnia benefit; titrate up if sedation becomes problematic.

What documents are available for Mirtazapine orders?

COA and MSDS are standard for commercial discussions. COO, packing list, invoice and other import-support documents can be arranged according to order scope.

Do you supply Mirtazapine to Australia and Canada?

Yes. We support B2B buyers in Australia, New Zealand, Canada and South Korea, subject to route and document review.

Do you supply New Zealand and South Korea?

Yes. We review Australia, New Zealand, Canada and South Korea for project supply, import documents, packaging and logistics planning before quotation.

Does Mirtazapine cause weight gain?

Yes. Mirtazapine frequently causes weight gain (average 2–4 kg over 6–8 weeks) due to H₁ antihistamine-mediated appetite stimulation and 5-HT₂C antagonism. This is therapeutically useful in depressed patients with appetite loss, cachexia, or underweight. It is a limitation for patients with obesity concerns.

What is the orally disintegrating tablet?

Remeron SolTab (mirtazapine ODT) dissolves on the tongue without water. It uses lyophilized tablet technology with rapid disintegration. ODT formulation is useful for patients with difficulty swallowing, medication compliance concerns, or nausea (the 5-HT₃ antagonism provides antiemetic benefit).

Can you arrange samples before commercial purchasing?

Samples or evaluation quantities may be reviewed for qualified buyers after target specification, application and destination-market requirements are clarified.

How is Mirtazapine packaged for export?

Packaging is confirmed by quantity and material properties. Typical options include foil bags, HDPE containers, fibre drums, 25 kg bags or palletized export packaging.

Can buyer-defined specifications be reviewed?

Yes. Send the specification, methods, impurity limits and required documents. TCS can review feasibility before confirming quotation and lead time.

What payment terms are normally used?

Standard payment is 100% T/T before dispatch unless a different arrangement has been approved for an established commercial account.

What lead time should buyers expect?

Lead time depends on stock, batch size, document scope and destination. Available stock can move faster; made-to-order or pallet programs require longer planning.

Is a DMF available?

Yes. TCS sources mirtazapine from manufacturers who maintain active DMFs with the FDA and ASMF/CEP with EMA. Off-patent with extensive generic competition. COA, stability data, and DMF reference letters are provided.

Last reviewed: June 2026

Evaluation and research orders (≤10 kg) are shipped with COA, MSDS, and certificate of origin. Bulk commercial orders (>10 kg) qualify for volume pricing with a full technical documentation package available on request.

> Request a Quote

If your team already has a target application, estimated quantity, destination market, or documentation requirements, send those details so the commercial response can be prepared more efficiently.

Contact the Commercial Team

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