Active Pharmaceutical Ingredient

Raloxifene

Also known as: Evista; Raloxifene HCl; Keoxifene

CAS: 84449-90-1 SERM IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Raloxifene API — Mediocon Inc
Raloxifene — Pharmaceutical Grade API

Product Overview

CAS No: 84449-90-1  |  MF: C₂₈H₂₇NO₄S  |  MW: 473.58 g/mol

Raloxifene is a pharmaceutical-grade active ingredient classified as a Selective Estrogen Receptor Modulator (SERM). Mediocon Inc supplies high-purity Raloxifene API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Raloxifene is a second-generation SERM that acts as an estrogen agonist in bone and cardiovascular tissues while acting as an estrogen antagonist in breast and uterine tissues. It is FDA-approved for the prevention and treatment of osteoporosis in postmenopausal women and for reducing the risk of invasive breast cancer.

Key Features

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

Applications

  • Osteoporosis prevention and treatment in postmenopausal women
  • Breast cancer risk reduction
  • Bone density maintenance in HRT
  • Cardiovascular risk profile improvement

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 NameRaloxifene
Also Known AsEvista; Raloxifene HCl; Keoxifene
CAS Number84449-90-1
Molecular FormulaC₂₈H₂₇NO₄S
Molecular Weight473.58 g/mol
CategorySERM — Selective Estrogen Receptor Modulator
AppearanceWhite to pale yellow crystalline powder
SolubilityInsoluble in water; freely soluble in DMSO and methanol
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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