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Isotretinoin API

Name of Product Isotretinoin
CAS No 4759-48-2
Therapeutic use:- cosmetic
Grade BP/USP
Form:- API Powder
Status Commercial

Product Overview

Isotretinoin API is a synthetic form of vitamin A, specifically a retinoid.

This substance is a yellow-to-orange powder.

It has a high ability to dissolve in fat, but a low ability to dissolve in water.

This API is mainly used in dermatology formulations.

It is sensitive to light and air, requiring controlled handling and storage.

Therapeutic Applications

Isotretinoin API is mainly used in products for severe acne that don’t respond to regular treatments.

The API aids in developing therapies that manage excess oil, calm skin inflammation, and promote normal skin cell growth.

It is also used in advanced dermatology and some oncology research.

In this case, strong retinoid activity helps meet specific treatment goals.

Specification Parameters

These parameters define the quality, purity, and safety standards for Isotretinoin API.

They guide us during production and quality control.

  • Chemical Name (IUPAC): (2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid

  • CAS Number: 4759-48-2

  • Molecular Formula: Câ‚‚â‚€H₂₈Oâ‚‚

  • Appearance: Yellow to orange crystalline or solid powder

  • Identification Tests: IR, UV, and HPLC comparison with reference standard

  • Assay Method: HPLC (primary); GC may be used for stability studies.

  • Assay Limit: Typically ≥ 99.0% on a dry basis (as per pharmacopeial standards)

  • Related Substances / Impurities: Controlled limits for isomers and degradation products.

  • Residual Solvents: Comply with ICH Q3C guidelines

  • Elemental Impurities: Meet ICH Q3D requirements

  • Loss on Drying: Typically ≤ 1.0%

  • Water Content: Controlled by the Karl Fischer method.

  • Microbial Limits: As per non-sterile API standards (generally low; N/A for sterile use)

  • Molecular Weight: ~300.44 g/mol

    Packaging & Storage

    Isotretinoin API is packed using HDPE or fiber drums.

    Typically, the packing sizes are 1 kg, 5 kg, and 25 kg drums.

    To maintain the API’s stability during storage and transport, it requires careful handling.

    Seal it securely to prevent light, air, and moisture from entering.

    Store it in a cool, dry place to ensure optimal condition and longevity.

    Why Choose Us

    Actiza Pharmaceutical Pvt. Ltd. offers trustworthy Isotretinoin API.

    We run certified facilities with top-notch quality systems in place.

    We focus on customer support to assist our global pharmaceutical partners.

    Certified Quality

    Our WHO-GMP– and ISO-certified plants meet strict standards.

    They have regular audits and maintain detailed records.

    This ensures every batch of Isotretinoin API is pure, safe, and traceable from start to finish.

    Advanced Facilities

    Modern infrastructure, controlled HVAC, segregation zones, and automated systems work hand in hand.

    Together, they help lower the risk of contamination and boost efficiency.

    This mix ensures stable production of Isotretinoin API in regulated operations that meet global standards.

    Flexible Supply

    No minimum order limits and bulk packaging options make it easy for partners to source Isotretinoin API.

    Good logistics mean you get timely delivery and competitive prices for your project needs.

    Customer Focus

    Dedicated teams ensure clear communication and support regulatory matters.

    They ensure timely updates, building long-term trust.

    This allows for accurate and consistent delivery of Isotretinoin API.

    Their responsive service strengthens worldwide partnerships.