Halobetasol Propionate API | Pharmaceutical API Manufacturer in India

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Halobetasol Propionate API

Halobetasol Propionate is a highly potent synthetic topical corticosteroid used to reduce inflammation, redness, itching and other symptoms associated with corticosteroid-responsive skin conditions. It belongs to the glucocorticoid class and is formulated for topical dermatological use.

Halobetasol Propionate is primarily used in the treatment of inflammatory and pruritic skin disorders such as plaque psoriasis and corticosteroid-responsive dermatoses.

Halobetasol Propionate API Manufacturer in India

Halobetasol Propionate is a high-potency dermatological pharmaceutical API requiring controlled steroid synthesis, purification and comprehensive impurity profiling. Manufacturing and quality control focus on chemical identity, assay, related substances, stereochemical integrity and residual impurities.

Chemical Information

CAS Number: 66852-54-8
Molecular Formula: C25H31ClF2O5
Molecular Weight: 484.96 g/mol
Chemical Name: Halobetasol Propionate
Drug Class: Corticosteroid
Pharmacological Class: Topical Glucocorticoid
Therapeutic Class: Dermatological / Anti-inflammatory
Therapeutic Area: Dermatology

Mechanism of Action

Halobetasol Propionate acts by binding to intracellular glucocorticoid receptors in target cells. The activated receptor complex influences gene transcription and suppresses the production and release of inflammatory mediators.

This results in reduced inflammation, erythema, edema and itching associated with corticosteroid-responsive skin disorders.

Pharmaceutical Applications

Halobetasol Propionate is used topically for inflammatory and pruritic corticosteroid-responsive dermatoses, including:

  • Plaque psoriasis
  • Eczema
  • Dermatitis
  • Other corticosteroid-responsive inflammatory skin conditions

Specific approved uses depend on the finished formulation and regulatory labeling.

Halobetasol Propionate in Dermatology

Halobetasol Propionate is considered a super-high-potency topical corticosteroid. Because of its high potency, topical formulations are generally intended for appropriate short-term use and under suitable medical direction.

Physical and Chemical Properties

Halobetasol Propionate is a synthetic fluorinated corticosteroid ester. It is generally obtained as a white to off-white crystalline powder and has very low water solubility, consistent with its lipophilic steroid structure.

Quality and Analytical Testing

Halobetasol Propionate API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay by HPLC
  • Related substances
  • Degradation products
  • Stereochemical purity
  • Water content
  • Residual solvents
  • Residue on ignition
  • Elemental impurities
  • Particle-size analysis where applicable

Storage

Halobetasol Propionate should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Exact storage conditions should follow validated stability data and the applicable product-specific specification.

Pharmaceutical Research and Development

Halobetasol Propionate is an established topical corticosteroid used in dermatological pharmaceutical development, particularly for formulations designed to provide potent local anti-inflammatory and antipruritic activity.

Halobetasol Propionate API Summary

Halobetasol Propionate is a high-potency synthetic topical glucocorticoid with CAS Number 66852-54-8, molecular formula C25H31ClF2O5, and molecular weight 484.96 g/mol. It is primarily used in topical formulations for psoriasis and other corticosteroid-responsive inflammatory skin disorders.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
pH (1% Solution) 5.0 – 7.0
Individual Impurity NMT 1.0%
Total Impurities ≤3.0%
Water Content NMT 1.0%
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