视黄醇/维生素A

The occurrence of nutrition deficiency diseases such as night blindness and xerophthalmia is directly related to the disorder of vitamin A metabolism in the body. As one of the active forms of vitamin A, retinol belongs to fat-soluble vitamin APIs, and exerts pharmacological effects by regulating rhodopsin synthesis, epithelial cell differentiation and immune function modulation. In clinical practice, it is used for the prevention and treatment of vitamin A deficiency, and can also be used as an excipient to participate in the preparation of compound nutritional preparations, covering children, pregnant women and the elderly population in need of nutritional supplementation. It is also the core active ingredient of external anti-aging and keratin regulating preparations in dermatology.

At present, the global market size of vitamin A APIs is about 1.8 billion US dollars, with a compound annual growth rate maintained at around 4.5%. Feed additives account for more than 60% of the downstream demand, and the demand proportion in the pharmaceutical and cosmetic fields has increased year by year to 27%. The competitive landscape is highly concentrated, with the top three global manufacturers accounting for a total market share of more than 80%. Chinese enterprises account for about 45% of the global production capacity by virtue of cost advantages. In recent years, with the tightening of environmental protection policies, small and medium-sized production capacity has been continuously cleared, and the price of APIs has obvious characteristics of periodic fluctuations.

The original research of retinol was first developed by Roche Pharmaceuticals, with the trade name of "Alphalin", and its core compound patent expired worldwide in the 1970s. At present, the mainstream marketed dosage forms include soft capsules, injections and topical creams. The common oral specifications are 5000 IU and 25000 IU, and the injection specification is 100,000 IU/1 ml. This product has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also included in the FDA Reference Preparation Catalogue. At present, 12 domestic enterprises have completed the CDE registration of retinol APIs and obtained the A status, and the approved and marketed preparation varieties cover a variety of dosage forms such as oral soft capsules, injections and topical gels. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of retinol impurity reference standards. Most of the products are available in stock. Spot orders paid before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API enterprises in R&D, quality research and compliance declaration.