Mianserin API Manufacturer in India

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Mianserin API

Mianserin is a tetracyclic antidepressant belonging to the piperazinoazepine class of compounds. It acts primarily by modulating central monoaminergic neurotransmission and is classified pharmacologically as a noradrenergic and specific serotonergic antidepressant (NaSSA)-related compound.

Mianserin has been used in the treatment of depressive disorders and is also associated with sedative and anxiolytic effects. It is a specialized CNS pharmaceutical API used in pharmaceutical development and research.

Mianserin API Manufacturer in India

Mianserin API is a specialized antidepressant pharmaceutical ingredient used in the development and manufacture of CNS formulations.

For the product page, it is important to distinguish Mianserin free base from Mianserin Hydrochloride. Mianserin free base has CAS 24219-97-4, while Mianserin Hydrochloride has CAS 21535-47-7.

Chemical Information

Product: Mianserin
CAS Number: 24219-97-4
Molecular Formula: C18H20N2
Molecular Weight: 264.36 g/mol
Hydrochloride CAS: 21535-47-7
Hydrochloride Formula: C18H21ClN2
Hydrochloride Molecular Weight: 300.80 g/mol

Drug Class: Tetracyclic Antidepressant
Therapeutic Class: Antidepressant
Therapeutic Area: Psychiatry / CNS
Molecule Type: Synthetic Small Molecule

Mechanism of Action

Mianserin acts on several central neurotransmitter systems. Its pharmacological profile includes antagonism at central α2-adrenergic receptors and activity at several serotonin receptors.

The resulting pharmacological effects include:

  • Modulation of noradrenergic neurotransmission
  • Modulation of serotonergic signaling
  • Antidepressant activity
  • Sedative effects
  • Anxiolytic activity

Pharmaceutical Applications

Mianserin API is associated with:

  • Depressive disorders
  • Antidepressant drug development
  • CNS pharmacology
  • Serotonergic receptor research
  • Noradrenergic receptor research
  • Tetracyclic antidepressant research

The current BP description identifies Mianserin Hydrochloride as a monoamine reuptake inhibitor and tetracyclic antidepressant.

Dosage Form Applications

Mianserin Hydrochloride has been used in oral pharmaceutical formulations, particularly tablets.

Physical Characteristics

Mianserin free base is a crystalline solid. For the hydrochloride form, the British Pharmacopoeia monograph specifies the substance as Mianserin Hydrochloride with CAS 21535-47-7 and molecular mass 300.8.

Manufacturing Process

A controlled Mianserin API manufacturing process may involve:

  1. Selection and qualification of starting materials
  2. Preparation of dibenzopyrazinoazepine intermediates
  3. Controlled chemical synthesis
  4. Formation of the piperazine-containing ring system
  5. Purification
  6. Hydrochloride salt formation where applicable
  7. Crystallization
  8. Filtration
  9. Controlled drying
  10. Final analytical testing
  11. Pharmaceutical-grade packaging

Quality Control Testing

For Mianserin Hydrochloride, the BP/Ph. Eur. monograph includes testing for:

  • Identification
  • pH
  • Related substances
  • Loss on drying
  • Sulfated ash
  • Assay

The published BP 2025 monograph specifies pH 4.0–5.5, loss on drying NMT 0.5%, and sulfated ash NMT 0.1%.

Storage

Mianserin Hydrochloride should be protected from light according to the BP monograph.

Pharmaceutical Research

Mianserin is relevant to research involving:

  • Depression
  • Tetracyclic antidepressants
  • Serotonin receptors
  • α2-adrenergic receptors
  • Noradrenergic neurotransmission
  • CNS pharmacology
  • Antidepressant drug development

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.5%
pH (1% Solution) 4.0 – 5.5
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 0.5%
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