Description

Isotretinoin CAS NO 4759-48-2 is a synthetic retinoid, a derivative of vitamin A, known for its potent biological activity. This high-purity active pharmaceutical ingredient (API) is critical for the development of effective dermatological treatments. It is primarily required by pharmaceutical manufacturers and research institutions focused on severe acne therapies and other dermatological conditions.

Application

• Pharmaceutical API: The primary active ingredient in oral formulations for the treatment of severe, recalcitrant nodular acne.
• Dermatological Research: Used in preclinical and clinical studies to investigate mechanisms of action related to sebum suppression and epithelial cell differentiation.
• Topical Formulation Development: A key component in the research and development of advanced topical creams and gels for various skin disorders.
• Oncology Research: Investigated for its potential effects on cellular proliferation and differentiation in certain cancer research models.
• Reference Standard: Serves as a high-purity analytical standard for quality control testing in pharmaceutical laboratories.
• Cosmeceutical R&D: Explored in advanced skincare research for its potent effects on skin cell renewal and regulation.

Basic Information

Product Name	Isotretinoin
CAS No.	4759-48-2
Molecular Formula	C20H28O2
Molecular Weight	300.44 g/mol
Synonyms	13-cis-Retinoic Acid; Ro 4-3780; Accutane (brand name); 13-cis-Vitamin A Acid; (2Z,4E,6E,8E)-3,7-Dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic Acid; Isotrex; Amnesteem; Claravis
EINECS	225-296-0

Quality Control

Our Isotretinoin is manufactured under strict quality systems to meet the rigorous standards required for pharmaceutical actives. Each batch is tested to ensure compliance with specifications for identity, purity, and potency. A comprehensive Certificate of Analysis (COA) is provided, detailing results from tests including HPLC assay, related substances, residual solvents, and heavy metals. We support compliance with cGMP (current Good Manufacturing Practice) guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store under an inert atmosphere (e.g., nitrogen) to prevent oxidation. The recommended storage temperature is between 2°C and 8°C (refrigerated). Keep the container in a dry, well-ventilated area, away from heat and incompatible materials.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.