Methyprylon API Manufacturer in India

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Methyprylon API

Methyprylon is a piperidinedione-class sedative-hypnotic compound that was historically used for the treatment of insomnia. It is also known by names including Metiprilon, Metiprilone, Noludar and Dimerin. NIST identifies Methyprylon with the molecular formula C10H17NO2, molecular weight 183.2475 g/mol, and CAS Number 125-64-4.

Methyprylon is a historical CNS depressant rather than a commonly marketed modern pharmaceutical. PubChem reports that it was withdrawn from the U.S. market in 1965 and from the Canadian market in 1990.

Methyprylon API Manufacturer in India

Methyprylon is a specialized CNS pharmaceutical compound relevant to pharmaceutical research, analytical reference applications and historical drug research. Its regulatory status should be assessed before commercial use in any specific market.

Chemical Information

CAS Number: 125-64-4
Molecular Formula: C10H17NO2
Molecular Weight: 183.2475 g/mol
IUPAC Name: 3,3-Diethyl-5-methylpiperidine-2,4-dione
Synonyms: Metiprilon, Metiprilone, Noludar, Dimerin
Drug Class: Piperidinedione Sedative-Hypnotic
Therapeutic Area: CNS / Sleep Disorders
Molecule Type: Synthetic Small Molecule

These chemical identifiers are reported by NIST and PubChem.

Mechanism of Action

Methyprylon is a central nervous system depressant. As a historical sedative-hypnotic, its pharmacological action reduces CNS activity and produces sedative and hypnotic effects.

Pharmaceutical Applications

Historically, Methyprylon was associated with:

  • Insomnia
  • Sedative-hypnotic therapy
  • CNS depressant research
  • Historical pharmaceutical research
  • Piperidinedione pharmacology

Physical Characteristics

NIST records Methyprylon as a solid. An evaluated infrared reference spectrum from the Coblentz Society reports a melting point of 74–77 °C.

Manufacturing Process

A controlled Methyprylon API manufacturing process may involve:

  1. Qualified starting materials
  2. Preparation of suitable synthetic intermediates
  3. Controlled chemical synthesis
  4. Formation of the piperidinedione structure
  5. Purification
  6. Crystallization
  7. Filtration
  8. Controlled drying
  9. Milling or sieving where applicable
  10. Final analytical testing
  11. Pharmaceutical-grade packaging

Quality Control Testing

Typical testing may include:

  • Identification by IR
  • HPLC identification
  • Assay
  • Related substances
  • Water content
  • Residual solvents
  • Elemental impurities
  • Melting point
  • Stability testing

Storage

Store Methyprylon in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.

Regulatory Consideration

Methyprylon has significant historical regulatory considerations. PubChem identifies it as a DEA Schedule III controlled substance and notes its withdrawal from the U.S. and Canadian markets.

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
Melting Point 74–77 °C
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