Active Pharmaceutical Ingredient

Dydrogesterone

Also known as: Duphaston; Dufaston

CAS: 152-62-5 Progestogen IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Dydrogesterone API — Mediocon Inc
Dydrogesterone — Pharmaceutical Grade API

Product Overview

CAS No: 152-62-5  |  MF: C₂₁H₂₈O₂  |  MW: 312.45 g/mol

Dydrogesterone is a synthetic progestogen used as an active pharmaceutical ingredient in hormonal therapy. Mediocon Inc supplies high-purity Dydrogesterone API conforming to IP / BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Dydrogesterone is indicated for the treatment of endometriosis, dysmenorrhoea, irregular cycles, premenstrual syndrome, and is widely used in assisted reproductive technology (ART) as luteal phase support.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Hormone replacement therapy
  • Endometriosis and dysmenorrhoea
  • Luteal phase support in ART
  • Premenstrual syndrome treatment

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameDydrogesterone
Also Known AsDuphaston; Dufaston
CAS Number152-62-5
Molecular FormulaC₂₁H₂₈O₂
Molecular Weight312.45 g/mol
CategoryProgestogen — Hormonal Agent
AppearanceWhite to off-white crystalline powder
SolubilityPractically insoluble in water; slightly soluble in ethanol
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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