Product Overview
Isotretinoin is an active pharmaceutical ingredient. It comes under the category of retinoids. It is the 13-cis isomer of retinoic acid.
It is a vitamin A derivative. Each batch of the API is subject to limits on assay, impurities, and basic physical characteristics.
This API is produced in controlled conditions to maintain the quality of the API.
It is not a medicine on its own but is supplied as a raw material for the manufacture of regulated formulations.
Therapeutic Applications
Isotretinoin is used as an API in the dermatology segment for oral and topical formulations.
It is a systemic/local retinoid in the finished form.
The usage, dosage form, and target population are specified in the product dossier. It is subject to local regulations.
Specification Parameters
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CAS Number: 4759-48-2
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Chemical Name: 13-cis-Retinoic acid (isotretinoin)
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Molecular Formula: C₂₀H₂₈O₂
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Molecular Weight: 300.4 g/mol
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Appearance: Yellow to orange crystalline powder
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Solubility: Practically insoluble in water; soluble in many organic solvents
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Purity (HPLC): Not less than 98.0 % (API grade, with limits for single and total related substances)
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Loss on Drying: Not more than the limit given in the agreed specification
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Residue on Ignition / Sulfated Ash: Within the agreed limit
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Elemental Impurities: Lead, cadmium, arsenic, nickel, and other elements kept within current guideline limits
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Identification Tests: Confirmed by IR spectrum, HPLC retention time
Packaging & Storage
Isotretinoin is packed in sealed, light-protected containers such as amber HDPE bottles or drums, or fibre drums with inner polyethylene or foil-lined bags.
Each container is clearly labelled with product name, batch number, net weight, manufacturing date, and retest or expiry date.
The API should be stored in a cool, dry place, away from direct sunlight, heat, and moisture, as it is light-sensitive.
The container should be kept tightly closed when not in use to protect the material from air and humidity.
Why Choose Us
As an Api Manufacturer, We supply isotretinoin with steady quality and low impurity levels.
We use fixed, validated test methods that meet API and GMP needs. You receive a clear batch.
We can provide pack sizes for lab work, pilot scale, and commercial production.
Our team answers technical and commercial questions in simple, direct language.
We plan long-term supply so your dermatology products are not at risk of stock gaps.
