Pirlindole API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Pirlindole is a pharmaceutical active ingredient belonging to the class of reversible monoamine oxidase-A (MAO-A) inhibitors. It is a tetracyclic compound also known by the synonym Pyrazidol and is associated with antidepressant pharmacological activity. Pirlindole acts as a selective and reversible inhibitor of MAO-A, an enzyme involved in the metabolism of neurotransmitters including serotonin and noradrenaline.

Pirlindole has the CAS Number 60762-57-4, molecular formula C15H18N2, and molecular weight 226.32 g/mol. The substance is registered in the FDA Global Substance Registration System (GSRS) under UNII V39YPH45FZ. PubChem also identifies 16154-78-2 as the related CAS number for the hydrochloride salt, which should not be confused with the free-base API.

Pirlindole API

Pirlindole is a well-characterized small-molecule pharmaceutical substance with activity primarily associated with selective, reversible inhibition of monoamine oxidase type A (MAO-A). Its pharmacological profile has been investigated extensively in relation to antidepressant activity and monoamine neurotransmitter regulation.

The API is chemically characterized by a tetracyclic pyrazino-carbazole structure. Pirlindole is available as the free-base substance as well as in salt forms, including Pirlindole Hydrochloride. For pharmaceutical manufacturing and documentation, the exact chemical form should always be specified because the free base and hydrochloride have different CAS numbers and molecular weights.

Chemical and Pharmaceutical Profile

Pirlindole has the molecular formula C15H18N2 and molecular weight 226.32 g/mol. PubChem reports an exact mass of 226.146998583 Da, one hydrogen-bond donor, one hydrogen-bond acceptor and a topological polar surface area of 17 Ų.

The compound is reported as a crystalline solid. Current analytical-reference sources report Pirlindole purity values of ≥98%, while one analytical-standard batch reports 99.98% assay/purity. These are reference-material/commercial analytical values and should not be represented as a universal pharmacopoeial release specification.

Key chemical information includes:

  • CAS Number: 60762-57-4
  • Molecular Formula: C15H18N2
  • Molecular Weight: 226.32 g/mol
  • Exact Mass: 226.146998583 Da
  • FDA GSRS UNII: V39YPH45FZ
  • PubChem CID: 68802
  • ChEBI ID: CHEBI:91755
  • Active Moiety: Pirlindole
  • Physical Form: Crystalline solid
  • Stereochemical Form: Racemic parent substance 

Pharmaceutical Applications

Pirlindole is primarily associated with pharmaceutical applications involving antidepressant and MAO-A inhibitor research. It is a selective and reversible inhibitor of MAO-A and has been investigated for its effects on monoamine neurotransmitter metabolism.

Potential pharmaceutical and research applications include:

  • Antidepressant drug development
  • MAO-A inhibitor research
  • Pharmaceutical research and development
  • API characterization
  • Analytical method development
  • Quality-control testing
  • Reference-standard applications
  • Formulation development research

Pirlindole analytical standards are used in HPLC, GC and MS applications for qualitative, quantitative and methodological research.

Quality and Analytical Testing

Pirlindole can be characterized using established analytical techniques to confirm its identity, purity and chemical properties. Typical analytical approaches include HPLC, mass spectrometry, NMR and chromatographic analysis.

Current commercial analytical references report Pirlindole purity at ≥98%, while a dedicated analytical-standard product reports 99.98% purity/assay. These values represent specific reference-material batches rather than a universal official API specification.

For pharmaceutical API applications, final testing should be performed against the applicable approved specification using validated analytical methods. Batch-specific quality should be confirmed through the relevant Certificate of Analysis (CoA).

Pirlindole API Manufacturer in India

As a Pirlindole API Manufacturer in India, pharmaceutical manufacturers can support research, development, analytical and commercial API requirements for this selective reversible MAO-A inhibitor.

Pirlindole API can be characterized and supplied according to applicable pharmaceutical quality requirements, with appropriate technical documentation and batch-specific analytical information.

Important product identifiers include:

  • CAS Number: 60762-57-4
  • Molecular Formula: C15H18N2
  • Molecular Weight: 226.32 g/mol
  • Active Moiety: Pirlindole
  • Chemical Form: Free base
  • Therapeutic Area: Neuropsychiatric/antidepressant
  • Pharmacological Class: Reversible MAO-A inhibitor
  • FDA GSRS UNII: V39YPH45FZ 

Packaging and Storage

Pirlindole API should be stored in suitable, tightly closed pharmaceutical packaging under controlled conditions that protect the material from excessive moisture, heat and other unsuitable environmental exposure.

Commercial storage conditions should be established according to the approved product specification, stability data and manufacturer documentation. Current analytical-reference sources recommend storage under controlled conditions, including −20°C for certain research-grade materials.

Packaging may be selected according to the intended application and quantity and may include:

  • Pharmaceutical-grade inner packaging
  • Moisture-protective containers
  • Sealed outer packaging
  • Bulk API packaging
  • Customized packaging for research and development requirements

Documentation

Depending on the intended pharmaceutical application, documentation for Pirlindole API may include:

  • Certificate of Analysis (CoA)
  • Product specification
  • Safety Data Sheet (SDS)
  • Batch analytical data
  • Stability information, where applicable
  • Technical documentation
  • Regulatory documentation, subject to availability
  • Analytical test reports

The applicable batch specification should always be used for final quality assessment rather than relying solely on values reported for research-grade reference materials.

Why Choose Pirlindole API

Pirlindole is a well-characterized small-molecule active ingredient with an established chemical identity and documented pharmacological activity as a selective and reversible MAO-A inhibitor. Its defined CAS Number 60762-57-4, molecular formula C15H18N2, and molecular weight 226.32 g/mol provide clear identifiers for pharmaceutical research, analytical characterization and API development.

For pharmaceutical applications, Pirlindole should be specified using the correct free-base form, CAS number, analytical specification and applicable quality requirements. The free base should also be clearly distinguished from Pirlindole Hydrochloride (CAS 16154-78-2) to prevent errors in pharmaceutical documentation, analytical testing and material identification.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Water Content NMT 0.5%
Melting Point 145°C
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