Isothipendyl API | Antihistamine API Manufacturer in India

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Isothipendyl API

Isothipendyl is a first-generation antihistamine belonging to the ethanolamine class of H1-receptor antagonists. It is primarily used for its antihistaminic and antipruritic properties, particularly in topical dermatological preparations.

Isothipendyl works by blocking histamine H1 receptors and thereby reducing histamine-mediated symptoms such as itching, redness and local irritation.

Isothipendyl API Manufacturer in India

Isothipendyl is a specialized antihistamine pharmaceutical API manufactured through controlled chemical synthesis, purification and crystallization.

Quality evaluation may include identity, assay, related substances, water content, residual solvents, elemental impurities, residue on ignition and stability.

Chemical Information

CAS Number: 122-63-4
Molecular Formula: C17H20N2S
Molecular Weight: 284.42 g/mol
Drug Class: Antihistamine
Pharmacological Class: H1-Receptor Antagonist
Therapeutic Class: Antiallergic / Antipruritic Agent
Therapeutic Area: Dermatology / Allergy

Mechanism of Action

Isothipendyl acts primarily as a histamine H1-receptor antagonist.

By blocking H1 receptors, it reduces the effects of histamine released during allergic and inflammatory reactions. This can help reduce:

  • Itching
  • Redness
  • Local skin irritation
  • Histamine-mediated allergic symptoms

Its topical use provides localized antihistaminic and antipruritic activity.

Pharmaceutical Applications

Isothipendyl is primarily associated with topical treatment of pruritic and minor allergic skin conditions.

It may be formulated into:

  • Topical creams
  • Gels
  • Dermatological preparations
  • Other topical antiallergic formulations

Specific applications depend on the approved formulation and regulatory market.

Antihistamine Characteristics

As a first-generation H1 antihistamine, isothipendyl has affinity for histamine H1 receptors and may also exhibit other pharmacological properties associated with older antihistamines.

Its principal pharmaceutical interest is its local antihistaminic and antipruritic action.

Manufacturing Process

Typical API manufacturing may involve:

  1. Preparation of appropriate aromatic intermediates
  2. Controlled chemical synthesis
  3. Condensation / coupling reactions
  4. Purification
  5. Crystallization
  6. Filtration
  7. Drying
  8. Milling where required
  9. Final analytical testing
  10. Controlled packaging

Quality and Analytical Testing

Isothipendyl API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay
  • Related substances
  • Organic impurities
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • Melting range
  • Particle-size distribution where required
  • Stability testing

Storage

Isothipendyl should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage requirements should be established from validated stability studies.

Pharmaceutical Research and Development

Isothipendyl is relevant to research involving:

  • H1 antihistamines
  • Histamine receptor pharmacology
  • Antiallergic agents
  • Antipruritic therapy
  • Topical dermatological formulations
  • Allergy research
  • Skin irritation and itching
  • Pharmaceutical formulation development

Isothipendyl API Summary

Isothipendyl is a first-generation H1 antihistamine with CAS Number 122-63-4, molecular formula C17H20N2S, and molecular weight 284.42 g/mol. It primarily acts by blocking histamine H1 receptors and is associated with topical antiallergic and antipruritic applications.

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%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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