Amylmetacresol

In response to the clinical needs of drug-resistant bacterial infection prevention and control, the differentiated advantages of phenolic antibacterial active ingredients have gradually been highlighted. As a bifunctional alkylphenol disinfection API, amylmetacresol achieves rapid sterilization by disrupting the permeability of microbial cell membranes and coagulating intracellular proteins, and has a broad-spectrum inhibitory effect on Gram-positive bacteria, Gram-negative bacteria and some fungi. At present, it is mainly used as the core component of external disinfection preparations in scenarios such as skin wound disinfection, adjuvant treatment of oral mucosal infections, and immersion disinfection of medical devices. It can also be used as a bacteriostatic additive in some oral care products, and the applicable population covers patients undergoing general trauma treatment, people with oral inflammation and operators in public health disinfection scenarios.

The global market size of amylmetacresol API was approximately USD 120 million in 2023, and the compound annual growth rate from 2024 to 2029 is expected to remain at 4.8%. The demand growth is mainly driven by the expansion of primary medical disinfection scenarios, the upgrading of oral care products and the increase in demand for pet medical disinfection. The current market supply is dominated by European and Chinese enterprises. European manufacturers focus on high-purity medicinal grade production capacity, and domestic enterprises have occupied more than 55% of the mid- and low-end market by virtue of their cost advantages. The domestic medicinal grade production capacity is still in the stage of gradual release, and there is no relevant implementation record of centralized procurement yet.

The original developer of amylmetacresol is Merck Group, Germany, with the original brand name Amylmetacresol, and its core compound patent has expired worldwide. The marketed original preparations are mainly compound buccal tablets, usually with a specification of 0.6 mg amylmetacresol per tablet, combined with 2.0 mg dichlorobenzyl alcohol and other ingredients. The original preparation has been included in the FDA Reference Listed Drug Catalog, and the original preparation has not been imported into China yet. In terms of domestic API registration, as of now, amylmetacresol APIs from 3 enterprises have passed the CDE review and publicity (Status A). The domestically approved marketed preparations containing amylmetacresol are mainly compound disinfection buccal tablets and external disinfection solutions. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for amylmetacresol API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the needs for impurity reference standards in all stages of API R&D, quality research and registration declaration.