Active Pharmaceutical Ingredient

Fludrocortisone

Also known as: Florinef (brand)

CAS: 127-31-1 Corticosteroid / Mineralocorticoid IP / BP / EP / USP Bulk Supply Available
Fludrocortisone API Manufacturer India | Mediocon Inc
Fludrocortisone — Pharmaceutical Grade API

Product Overview

CAS No: 127-31-1  |  MF: C₂₁H₂₉FO₅  |  MW: 380.45 g/mol

Fludrocortisone is a synthetic corticosteroid with potent mineralocorticoid activity used to treat adrenocortical insufficiency (Addison's disease), salt-losing adrenogenital syndrome, and orthostatic hypotension. It acts on mineralocorticoid receptors to enhance sodium retention.

Mediocon Inc supplies Fludrocortisone IP/BP/EP/USP as a pharmaceutical-grade active ingredient for endocrinology and adrenal disorder formulations worldwide. Our facility adheres to strict GMP guidelines, ensuring consistent quality, purity, and regulatory compliance.

Key Features

  • Potent mineralocorticoid activity
  • Multi-pharmacopoeial compliance (IP/BP/EP/USP)
  • Strict GMP manufacturing
  • Full quality documentation

Applications

  • Addison's disease (adrenal insufficiency) therapy
  • Salt-losing adrenogenital syndrome
  • Orthostatic hypotension management
  • Endocrinology formulation manufacturing

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 NameFludrocortisone
CAS Number127-31-1
Molecular FormulaC₂₁H₂₉FO₅
Molecular Weight380.45 g/mol
CategoryCorticosteroid / Mineralocorticoid
AppearanceWhite to Off-White Crystalline Powder
GradeIP / BP / EP / USP
Packaging25 kg HDPE Drums / Aluminium Bags
StorageCool, Dry & Ventilated Place

Analytical Specifications

ParameterSpecification
AssayNLT 97.0% & NMT 103.0%
Loss on DryingNMT 1.0%
Heavy MetalsNMT 10 ppm
Specific Rotation+155° to +165°
Microbial LimitsComplies
IdentificationIR & TLC Compliant
Related SubstancesComplies USP
Packing25 kg HDPE drums / as per requirement
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