Diethylpropion API Manufacturer in India | Diethylpropion Supplier

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

Diethylpropion API Manufacturer and Supplier in India

Diethylpropion is a sympathomimetic pharmaceutical active ingredient belonging to the anorectic agent class. It has been used as a short-term adjunct to dietary and behavioral measures for weight management in selected patients with obesity.

Diethylpropion API

Diethylpropion, also known as Amfepramone, is a synthetic phenethylamine derivative with central nervous system stimulant and appetite-suppressing activity. It is commonly encountered pharmaceutically as diethylpropion hydrochloride.

Diethylpropion is identified by CAS No. 90-84-6. It has the molecular formula C13H19NO and a molecular weight of approximately 205.30 g/mol.

Pharmacological Properties

Diethylpropion primarily acts as a sympathomimetic amine and produces appetite-suppressing effects through activity involving central catecholaminergic neurotransmission.

Its pharmacological effects can include increased alertness and reduced appetite, which contribute to its historical use in short-term weight-management therapy.

Mechanism of Action

Diethylpropion and its active metabolites influence central nervous system catecholamine pathways, particularly norepinephrine signaling. Increased catecholaminergic activity in appetite-regulating regions of the brain is associated with reduced hunger and food intake.

Pharmaceutical Applications

Diethylpropion has been used as a short-term adjunct in the management of exogenous obesity, generally in conjunction with caloric restriction and lifestyle measures.

Its approved indications, availability and regulatory status vary by country and jurisdiction.

Diethylpropion Hydrochloride

The pharmaceutical form commonly encountered is Diethylpropion Hydrochloride. When creating a CMS product record, the free base and hydrochloride salt should be clearly distinguished because their CAS numbers, molecular formulas and molecular weights differ.

Quality Control

Diethylpropion API quality evaluation may include:

  • Appearance
  • Identification
  • Assay
  • Related substances
  • Residual solvents
  • Loss on drying
  • Water content
  • Residue on ignition
  • Elemental impurities
  • Melting point
  • Solubility
  • Other applicable pharmaceutical quality attributes

Final acceptance criteria should be based on the approved specification and applicable pharmacopoeial requirements.

Manufacturing and Regulatory Considerations

Diethylpropion intended for pharmaceutical manufacturing should comply with applicable GMP, quality-control and regulatory requirements. Because regulatory controls for sympathomimetic/anorectic substances can differ between jurisdictions, the intended market and applicable regulatory status should be verified before commercial use.

A batch-specific Certificate of Analysis (CoA) should provide applicable analytical results and acceptance criteria.

Storage and Handling

Diethylpropion API should be stored in appropriately sealed packaging under the manufacturer's specified conditions. Protection from excessive moisture, heat and unsuitable environmental exposure should be maintained.

Diethylpropion API Supplier in India

Diethylpropion is relevant to pharmaceutical manufacturers and formulation-development organizations working with appetite-suppressant and weight-management pharmaceutical products, subject to applicable regulatory requirements.

For commercial applications, customers should verify the API form, grade, assay, impurity profile, specification, regulatory documentation and batch-specific CoA before use.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) NLT 98.0% by HPLC
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 1.0%
Total Impurities NMT 2.0%
Water Content NMT 1.0%
Melting Point 150°C – 154°C
Get Bulk Quote via WhatsApp