O-Desmethyl Venlafaxine API Manufacturer in India

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O-Desmethyl Venlafaxine API

O-Desmethyl Venlafaxine, also known as Desvenlafaxine or ODV, is the major active O-demethylated metabolite of venlafaxine. It belongs to the serotonin-norepinephrine reuptake inhibitor (SNRI) class and is associated with inhibition of serotonin and norepinephrine reuptake. The free-base substance has the molecular formula C₁₆H₂₅NO₂ and a molecular weight of approximately 263.38 g/mol. Its CAS Registry Number is 93413-62-8.

Chemical and Pharmaceutical Profile

  • Product Name: O-Desmethyl Venlafaxine
  • Synonym: Desvenlafaxine
  • Common Abbreviation: ODV
  • CAS Number: 93413-62-8
  • Molecular Formula: C₁₆H₂₅NO₂
  • Molecular Weight: 263.38 g/mol
  • Chemical Class: Tertiary amino compound / cyclohexanol / phenol
  • Therapeutic Class: Serotonin-norepinephrine reuptake inhibitor
  • Physical Form: White to off-white crystalline powder or solid

PubChem identifies O-desmethylvenlafaxine as the active metabolite of venlafaxine and lists CAS 93413-62-8 for the free-base substance.

Pharmaceutical Applications

Desvenlafaxine is an active pharmaceutical ingredient used in the development and manufacture of pharmaceutical products intended for the management of major depressive disorder. The compound acts primarily through inhibition of serotonin and norepinephrine reuptake, increasing the availability of these neurotransmitters in the central nervous system.

O-Desmethyl Venlafaxine is also an important analytical and reference compound because it is the principal active metabolite formed from venlafaxine. It is used in pharmaceutical analytical development, impurity profiling, bioanalytical testing and research involving venlafaxine metabolism.

Quality and Pharmacopoeial Information

A USP-NF monograph exists for Desvenlafaxine free base, defining the substance as containing 98.0%–102.0% desvenlafaxine on the dried basis. USP identification includes infrared spectroscopy and chromatographic retention-time comparison. The USP monograph also specifies loss on drying NMT 0.50% and residue on ignition NMT 0.20%.

The USP organic-impurity procedure specifies limits for desvenlafaxine related compound A, venlafaxine and unspecified impurities, with a total impurity limit of NMT 0.50% in the published USP 2025 text.

Physical Properties

O-Desmethyl Venlafaxine is reported as a white to light-yellow powder or crystalline solid. TCI reports an HPLC purity specification of NLT 98.0 area% for its research-grade material and a melting-point specification of 221–225°C. A pharmaceutical product monograph describes desvenlafaxine as a white to off-white crystalline powder and notes that its solubility is pH dependent.

Important API Form Distinction

O-Desmethyl Venlafaxine free base must be distinguished from Desvenlafaxine Succinate. Desvenlafaxine succinate is a separate salt form with different CAS numbers, molecular weight and water-content requirements. USP lists the monohydrate as CAS 386750-22-7 and the anhydrous form as CAS 448904-47-0.

For pharmaceutical manufacturing, analytical testing should therefore be performed against the specification applicable to the exact API form supplied, including identity, assay, related substances, residual solvents, water and other applicable quality attributes.

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 0.50%
Residue on Ignition NMT 0.20%
Individual Impurity NMT 0.15%
Total Impurities NMT 0.50%
Water Content NMT 0.50%
Melting Point 221–225°C
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