Tretinoin API Manufacturer and Supplier in India

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Tretinoin API Manufacturer and Supplier in India

Swapnroop Drugs & Pharmaceuticals is a pharmaceutical API manufacturer and supplier of Tretinoin, also known as all-trans-Retinoic Acid (ATRA) or Retinoic Acid. Tretinoin is a synthetic retinoid and vitamin A metabolite used in pharmaceutical applications, including dermatological formulations and treatment regimens for acute promyelocytic leukemia (APL).

Tretinoin is identified by CAS No. 302-79-4, molecular formula C20H28O2, and molecular weight 300.44 g/mol. USP identifies Tretinoin as retinoic acid/all-trans-retinoic acid.

Tretinoin API Overview

Tretinoin is the all-trans isomer of retinoic acid and belongs to the retinoid class of pharmaceutical compounds. It acts through nuclear retinoic acid receptors and influences cellular differentiation and proliferation.

Tretinoin is used in pharmaceutical products for acute promyelocytic leukemia and in topical dermatological preparations for conditions including acne vulgaris. FDA chemistry documentation identifies Tretinoin as a drug substance used in approved topical products and describes it as sparingly soluble in water and sensitive to oxygen and light.

Chemical and Pharmaceutical Profile

  • Product Name: Tretinoin
  • Synonyms: All-trans-Retinoic Acid, Retinoic Acid, ATRA, Vitamin A Acid
  • CAS Number: 302-79-4
  • Molecular Formula: C20H28O2
  • Molecular Weight: 300.44 g/mol
  • Chemical Class: Retinoid
  • Pharmacological Class: Retinoic Acid Receptor Agonist
  • Therapeutic Category: Dermatology / Oncology
  • API Type: Synthetic Small-Molecule API
  • Physical Form: Crystalline powder
  • Appearance: Yellow to light-orange crystalline powder
  • Isomeric Form: All-trans
  • Melting Point: Approximately 180–184°C
  • Water Solubility: Practically insoluble in water

PubChem identifies Tretinoin as all-trans-retinoic acid with CAS 302-79-4, C20H28O2 and molecular weight 300.4 g/mol. Reported physical data describe it as a yellow to light-orange crystalline powder with a melting range around 180–184°C and very low water solubility.

Pharmaceutical Applications

Tretinoin API is used in pharmaceutical applications involving:

  • Acute promyelocytic leukemia (APL)
  • Dermatological formulations
  • Acne vulgaris treatment
  • Topical retinoid formulations
  • Retinoic acid receptor-mediated pharmaceutical research
  • Oncology drug development
  • Pharmaceutical formulation development

Tretinoin API Manufacturer and Supplier

Swapnroop Drugs & Pharmaceuticals provides Tretinoin API for pharmaceutical formulation and manufacturing applications.

As a Tretinoin API manufacturer and supplier in India, Swapnroop supports pharmaceutical customers requiring controlled-quality Tretinoin with appropriate identification, assay, moisture, inorganic impurity and stereochemical/isomer-related quality controls according to the applicable specification.

Packaging and Storage

Tretinoin is sensitive to light and oxygen. USP specifies preservation in tight containers, preferably under an inert atmosphere, with protection from light. Tretinoin should therefore be handled using suitable light-protective packaging and controlled storage conditions.

Documentation

Typical pharmaceutical documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Batch Analytical Report
  • Safety Data Sheet (SDS)
  • Identification Data
  • Assay Report
  • Isomer/Related Substance Profile
  • Residual Solvent Data
  • Stability Documentation
  • Manufacturing Documentation
  • Regulatory Documentation, where applicable

Why Choose Swapnroop for Tretinoin API?

Swapnroop Drugs & Pharmaceuticals supports pharmaceutical customers seeking reliable Tretinoin API supply for dermatological and oncology applications, with emphasis on product identity, purity, controlled handling and appropriate pharmaceutical documentation.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 97.0–103.0% on dried basis
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.1%
Melting Point 180–184°C
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