Mometasone Furoate IP/USP/BP/EP — A Comprehensive Pharmaceutical Insight

 

Mometasone Furoate IP/USP/BP/EP — A Comprehensive Pharmaceutical Insight

By Swapnroop Drugs and Pharmaceuticals

Introduction

Mometasone Furoate is a highly potent synthetic corticosteroid widely used in dermatological, nasal, and respiratory formulations. Due to its strong anti-inflammatory activity combined with minimal systemic absorption, it is considered a preferred Active Pharmaceutical Ingredient (API) in modern therapy.

Recognized by major global pharmacopoeias — Indian Pharmacopoeia (IP), United States Pharmacopeia (USP), British Pharmacopoeia (BP), and European Pharmacopoeia (EP) — Mometasone Furoate plays a critical role in regulated pharmaceutical markets worldwide.

At Swapnroop Drugs and Pharmaceuticals, we supply high-quality Mometasone Furoate API manufactured in compliance with international pharmacopoeial and GMP standards, supporting safe and effective finished dosage formulations.

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1. Chemical Identity and Structure

Mometasone Furoate is the furoate ester of mometasone, a synthetic glucocorticoid. Its chemical structure is specifically designed to enhance lipophilicity and receptor binding while reducing systemic exposure.

Key Characteristics:

• Molecular Formula: C₂₇H₃₀Cl₂O₆
• Molecular Weight: ~521.43 g/mol
• Appearance: White to off-white crystalline powder
• Solubility: Practically insoluble in water, soluble in organic solvents

The presence of halogenated substitutions and the furoate ester group significantly improves its topical and localized activity, making it ideal for nasal sprays, inhalers, and dermatological formulations.

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

Mometasone Furoate is officially listed in multiple pharmacopoeias, each defining strict quality and analytical requirements.

Indian Pharmacopoeia (IP)

• Identification by IR and chromatographic methods
• Assay and related substances limits
• Control of residual solvents and impurities

United States Pharmacopeia (USP)

• High-precision HPLC assay requirements
• Tight impurity profiling
• Compliance with stability and storage guidelines

British & European Pharmacopoeia (BP/EP)

• Harmonized testing protocols
• Strict purity and stereochemical controls
• Defined limits for degradation products

Swapnroop Drugs and Pharmaceuticals ensures that every batch of Mometasone Furoate API meets or exceeds these pharmacopoeial specifications, enabling seamless regulatory submissions across global markets.

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3. Mechanism of Action

Mometasone Furoate functions as a glucocorticoid receptor agonist, exerting its therapeutic effect by:

• Inhibiting inflammatory mediator release
• Suppressing cytokine and chemokine production
• Reducing capillary permeability and tissue edema

Its strong receptor affinity allows effective symptom control at low doses, minimizing systemic corticosteroid-related adverse effects.

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4. Therapeutic Applications

Mometasone Furoate is used in a wide range of corticosteroid-responsive conditions:

Dermatological Applications

• Eczema
• Psoriasis
• Atopic and contact dermatitis
• Other inflammatory skin disorders

Nasal Formulations

• Seasonal and perennial allergic rhinitis
• Nasal polyps
• Chronic nasal inflammation

Inhalation Therapy

• Maintenance treatment of asthma
• Prevention of inflammatory airway responses

Its versatility across multiple dosage forms makes it a highly valuable API for pharmaceutical manufacturers.

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5. Pharmacokinetics and Safety Profile

One of the most important advantages of Mometasone Furoate is its low systemic bioavailability, especially when administered topically or intranasally.

Key Safety Attributes:

• Minimal absorption into systemic circulation
• Extensive first-pass metabolism when absorbed
• Low risk of hypothalamic-pituitary-adrenal (HPA) axis suppression

Common side effects are usually mild and localized, such as irritation or dryness at the site of application when used as recommended.

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6. Manufacturing & Quality Assurance

The manufacture of Mometasone Furoate requires advanced process control due to its potency and sensitivity.

At Swapnroop Drugs and Pharmaceuticals, quality assurance includes:

• GMP-compliant manufacturing processes
• Validated analytical methods
• Batch-to-batch consistency
• Comprehensive documentation including COA, MSDS, and regulatory support

Our commitment to quality ensures reliable performance in finished pharmaceutical formulations.

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Conclusion

Mometasone Furoate remains a cornerstone corticosteroid API due to its high efficacy, excellent safety profile, and global pharmacopoeial acceptance. Its role in dermatological, nasal, and respiratory therapies continues to expand across regulated and emerging markets.

Swapnroop Drugs and Pharmaceuticals stands as a trusted partner for pharmaceutical companies seeking high-quality Mometasone Furoate IP/USP/BP/EP, backed by regulatory compliance, technical expertise, and consistent supply.

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About Swapnroop Drugs and Pharmaceuticals

Swapnroop Drugs and Pharmaceuticals is a quality-driven pharmaceutical company specializing in Active Pharmaceutical Ingredients. With a strong focus on compliance, reliability, and customer satisfaction, we support formulation development across global markets.