MEDIOCON INC – Isotretinoin is a retinoid pharmaceutical active ingredient and a stereoisomer of tretinoin. It is widely recognized for its use in the treatment of severe acne and belongs to the retinoid class of vitamin A derivatives.
Isotretinoin is a synthetic retinoid chemically related to vitamin A. It is primarily used in pharmaceutical formulations for the management of severe nodular acne that has not responded adequately to conventional treatments.
Isotretinoin affects several biological processes involved in acne development, including sebaceous gland activity, keratinization and inflammatory processes.
Product Name: Isotretinoin
CAS Number: 4759-48-2
Molecular Formula: C₂₀H₂₈O₂
Molecular Weight: 300.44 g/mol
Chemical Class: Retinoid
Therapeutic Class: Anti-Acne Agent / Retinoid
IUPAC Name: (2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid
Synonyms: Isotretinoin, 13-cis-Retinoic Acid, 13-cis-Retinoic acid, Isotretinoinum
Parent Compound Class: Retinoic Acid Derivative
Isotretinoin is a retinoid that produces significant effects on the sebaceous glands and follicular keratinization.
It reduces sebaceous gland activity and sebum production, helps normalize abnormal follicular keratinization and contributes to reduction of inflammatory acne lesions.
Isotretinoin is the 13-cis isomer of retinoic acid and can undergo biological isomerization to other retinoid forms.
MEDIOCON INC focuses on supplying pharmaceutical active ingredients with emphasis on quality, consistency, technical documentation and reliable supply.
Isotretinoin quality evaluation may include:
Because Isotretinoin is sensitive to light, oxygen and environmental conditions, appropriate handling, storage and packaging controls are important.
The exact acceptance criteria should be confirmed against the applicable approved specification and batch-specific Certificate of Analysis.
Isotretinoin may be used in:
Use of isotretinoin is subject to strict medical and regulatory controls because of its well-established teratogenic risk.
Isotretinoin is generally described as a yellow to orange crystalline powder.
Appearance: Yellow to orange crystalline powder
The exact commercial appearance specification should be confirmed against the applicable MEDIOCON INC product specification and batch COA.
Isotretinoin should generally be protected from light, excessive heat, moisture and oxidation.
The precise storage temperature and packaging requirements should follow the applicable product specification, stability data and validated storage conditions.
Product availability, packaging configuration, Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), technical specifications and analytical documentation should be confirmed with MEDIOCON INC according to customer requirements and applicable regulatory standards.
Regulatory / Safety Note: Isotretinoin is a potent retinoid with significant teratogenic risk. Pharmaceutical handling, manufacture, distribution and use must comply with applicable regulatory requirements.
| Parameter | Specification |
|---|---|
| Appearance | Yellow to orange crystalline powder |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Isotretinoin API Manufacturer and Supplier in India (CAS 4759-48-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Isotretinoin API Manufacturer and Supplier in India is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
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