Active Pharmaceutical Ingredient

Spironolactone

Also known as: Aldactone; Spiractin; CaroSpir

CAS: 52-01-7 Aldosterone Antagonist BP / EP / USP / INH / FCC / NF GMP Certified Aurangabad, Maharashtra, India
Spironolactone API — Mediocon Inc
Spironolactone — Pharmaceutical Grade API

Product Overview

CAS No: 52-01-7  |  MF: C₂₄H₃₂O₄S  |  MW: 416.57 g/mol

Spironolactone is a synthetic steroidal aldosterone antagonist used as an active pharmaceutical ingredient. Mediocon Inc supplies high-purity Spironolactone API conforming to BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Spironolactone competitively blocks aldosterone receptors in the distal nephron, causing sodium excretion and potassium retention. It is used for heart failure, primary hyperaldosteronism, resistant hypertension, oedema, and as an antiandrogen in acne and hirsutism.

Key Features

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

Applications

  • Heart failure and oedema treatment
  • Primary hyperaldosteronism
  • Resistant hypertension
  • Acne and hirsutism (antiandrogen use)

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 NameSpironolactone
Also Known AsAldactone; Spiractin; CaroSpir
CAS Number52-01-7
Molecular FormulaC₂₄H₃₂O₄S
Molecular Weight416.57 g/mol
CategoryAldosterone Antagonist — Diuretic
AppearanceLight cream to light tan crystalline powder
SolubilityPractically insoluble in water; soluble in ethanol and chloroform
GradeBP / EP / USP / INH / FCC / NF

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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