Spironolactone IP/BP/USP/EP – A Comprehensive Overview of a Potassium-Sparing Diuretic API

 

Spironolactone IP/BP/USP/EP – A Comprehensive Overview of a Potassium-Sparing Diuretic API

By Swapnroop Drugs & Pharmaceuticals

Introduction

Spironolactone is a synthetic steroidal compound widely used as a potassium-sparing diuretic and aldosterone antagonist. It plays a crucial role in the management of cardiovascular, renal, endocrine, and dermatological disorders. Due to its dual diuretic and anti-androgenic properties, Spironolactone remains an essential Active Pharmaceutical Ingredient (API) in modern therapeutics.

Spironolactone is officially recognized in major global pharmacopoeias — Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP), and European Pharmacopoeia (EP) — making it a highly regulated and globally accepted API.

At Swapnroop Drugs & Pharmaceuticals, we supply high-quality Spironolactone IP/BP/USP/EP, manufactured under stringent GMP standards to meet international regulatory and quality requirements.

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1. Chemical Identity & Characteristics

Spironolactone is a synthetic steroid derived from progesterone, structurally modified to antagonize aldosterone receptors.

Key Chemical Properties:

• Molecular Formula: C₂₄H₃₂O₄S
• Molecular Weight: ~416.57 g/mol
• Appearance: White or almost white crystalline powder
• Solubility: Practically insoluble in water; soluble in organic solvents

Its unique sulfur-containing lactone ring contributes to its pharmacological activity and metabolic profile.

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2. Pharmacopoeial Standards (IP / BP / USP / EP)

Spironolactone is listed across all major pharmacopoeias, each defining rigorous quality specifications:

Indian Pharmacopoeia (IP)

• Identification tests using IR and chromatographic methods
• Defined assay and impurity limits
• Control of residual solvents

United States Pharmacopeia (USP)

• HPLC-based assay and impurity profiling
• Strict limits on related substances
• Stability and storage requirements

British & European Pharmacopoeia (BP/EP)

• Harmonized quality parameters
• Control of degradation products
• Defined packaging and labeling standards

Swapnroop Drugs & Pharmaceuticals ensures full pharmacopoeial compliance, enabling smooth regulatory filings and global market access.

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3. Mechanism of Action

Spironolactone acts as a competitive antagonist of aldosterone at mineralocorticoid receptors in the distal renal tubules.

Its pharmacological effects include:

• Inhibition of sodium and water reabsorption
• Reduction of potassium excretion
• Lowering of blood volume and blood pressure
• Anti-androgenic activity via androgen receptor antagonism

These actions make it effective in both cardiovascular and hormonal disorders.

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4. Therapeutic Applications

Spironolactone is widely used across multiple therapeutic areas:

Cardiovascular & Renal Disorders

• Hypertension
• Congestive heart failure
• Edema associated with liver or kidney disease

Endocrine & Hormonal Conditions

• Primary hyperaldosteronism
• Polycystic ovary syndrome (PCOS)
• Hormonal acne and hirsutism

Other Clinical Uses

• Resistant hypertension
• Prevention of hypokalemia caused by other diuretics

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5. Pharmacokinetics & Safety Profile

Spironolactone is well absorbed orally and extensively metabolized to active metabolites, including canrenone.

Key Safety Considerations:

• Risk of hyperkalemia, especially in renal impairment
• Dose-dependent endocrine effects
• Well-established clinical usage guidelines

When used appropriately, Spironolactone offers a favorable benefit-risk profile.

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6. Manufacturing & Quality Assurance

The manufacturing of Spironolactone requires precise process control due to its steroidal structure.

At Swapnroop Drugs & Pharmaceuticals, quality assurance includes:

• GMP-certified manufacturing facilities
• Validated production and analytical methods
• Comprehensive impurity and stability testing
• Complete regulatory documentation (COA, MSDS, DMF support)

This ensures consistent quality and reliability in finished pharmaceutical formulations.

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Conclusion

Spironolactone remains a vital API due to its unique potassium-sparing diuretic and anti-androgenic properties. Its wide therapeutic applicability and strong pharmacopoeial acceptance make it an essential component in cardiovascular, renal, and endocrine therapies.

Swapnroop Drugs & Pharmaceuticals is a trusted global supplier of Spironolactone IP/BP/USP/EP, delivering high-purity APIs that support safe, effective, and compliant pharmaceutical products worldwide.

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About Swapnroop Drugs & Pharmaceuticals

Swapnroop Drugs & Pharmaceuticals specializes in the supply of high-quality Active Pharmaceutical Ingredients (APIs), manufactured in compliance with international GMP and regulatory standards. Our focus on quality, consistency, and customer satisfaction enables long-term partnerships with pharmaceutical manufacturers across the globe.