Hydrocortisone Valerate API | Corticosteroid Pharmaceutical API Manufacturer in India

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Hydrocortisone Valerate API

Hydrocortisone Valerate is a synthetic corticosteroid and ester derivative of hydrocortisone used primarily as a topical anti-inflammatory agent. It belongs to the glucocorticoid class and helps reduce inflammation, redness, itching and other symptoms associated with corticosteroid-responsive skin conditions.

Hydrocortisone Valerate is particularly suitable for topical dermatological formulations, including creams, ointments and lotions.

Hydrocortisone Valerate API Manufacturer in India

Hydrocortisone Valerate is a specialized corticosteroid pharmaceutical API requiring controlled steroid synthesis, purification and analytical characterization. Manufacturing and quality control typically focus on chemical identity, assay, related substances, stereochemical purity, residual solvents and degradation products.

Chemical Information

CAS Number: 575-90-6
Molecular Formula: C26H36O6
Molecular Weight: 444.57 g/mol
Chemical Name: Hydrocortisone 17-valerate
Drug Class: Corticosteroid
Pharmacological Class: Glucocorticoid
Therapeutic Class: Topical Anti-inflammatory
Therapeutic Area: Dermatology

Mechanism of Action

Hydrocortisone Valerate acts through the glucocorticoid receptor in cells. After receptor binding, the corticosteroid-receptor complex influences gene expression and suppresses multiple inflammatory pathways.

This reduces the production and activity of inflammatory mediators, helping decrease erythema, edema, itching and inflammation in responsive skin conditions.

Pharmaceutical Applications

Hydrocortisone Valerate is used in topical formulations for corticosteroid-responsive dermatological conditions, including:

  • Atopic dermatitis
  • Eczema
  • Contact dermatitis
  • Allergic dermatitis
  • Other inflammatory skin disorders
  • Corticosteroid-responsive dermatoses

The specific approved indications and strengths depend on the finished pharmaceutical formulation and local regulatory requirements.

Hydrocortisone Valerate in Dermatology

Hydrocortisone Valerate provides topical glucocorticoid activity and is formulated to deliver corticosteroid action directly to affected skin. Its ester structure influences its lipophilicity, skin penetration and formulation characteristics.

Physical and Chemical Properties

Hydrocortisone Valerate is a synthetic steroid ester generally appearing as a white or almost white crystalline powder. It has very low solubility in water and is soluble in selected organic solvents.

The molecule contains the characteristic corticosteroid steroid nucleus and a valerate ester group.

Quality and Analytical Testing

Hydrocortisone Valerate API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay by HPLC
  • Related substances
  • Steroid-related impurities
  • Degradation products
  • Water content
  • Residual solvents
  • Residue on ignition
  • Elemental impurities
  • Specific optical rotation
  • Melting range

Storage

Hydrocortisone Valerate should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Storage conditions should follow validated stability data and the applicable product specification.

Pharmaceutical Research and Development

Hydrocortisone Valerate is relevant to pharmaceutical development involving topical glucocorticoids, inflammatory skin disorders, corticosteroid receptor activity and dermatological formulations.

Hydrocortisone Valerate API Summary

Hydrocortisone Valerate is a synthetic topical glucocorticoid corticosteroid with CAS Number 575-90-6, molecular formula C26H36O6, and molecular weight 444.57 g/mol. It is primarily used as an active ingredient in topical dermatological formulations for corticosteroid-responsive inflammatory skin conditions.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification 97.0% – 103.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
Melting Point Approximately 220–224°C,
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