Active Pharmaceutical Ingredient

Promestriene — CAS 39219-28-8

Also known as: Colpotrophine (brand); 3-Propyl-17β-methyl estradiol

GMP Certified IP / BP / EP / USP Estrogen / Hormone Therapy Aurangabad, India
Promestriene API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Promestriene IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 39219-28-8

Product Overview

Promestriene is a synthetic estrogen ester used locally in the management of vaginal atrophy and associated symptoms of menopause. Mediocon Inc manufactures this high-purity API at its GMP-certified facility in Aurangabad, Maharashtra, India. It acts locally with minimal systemic absorption, making it suitable for long-term use in postmenopausal women.

Therapeutic Applications
  • Treatment of vulvovaginal atrophy in postmenopausal women
  • Relief of vaginal dryness, burning, and dyspareunia
  • Preparative treatment for vaginal and gynecological procedures
  • Local hormone therapy with minimal systemic estrogenic effects

Technical Specifications

ParameterSpecification
CAS Number39219-28-8
Molecular FormulaC21H32O2
Molecular Weight316.47 g/mol
GradeIP / BP / EP / USP
CategoryEstrogen / Hormone Therapy
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoPRO/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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