Cetylpyridinium Chloride

As a cationic quaternary ammonium salt disinfectant and preservative commonly used in clinical practice, cetylpyridinium chloride can reduce surface tension, destroy the structure of bacterial cell membranes, promote the coagulation and denaturation of bacterial proteins, and also has an inhibitory effect on some fungi, with extremely low irritation to oral mucosa and skin. Its indications cover scenarios such as prevention and adjuvant treatment of local oral infections, disinfection of skin and mucosa, and local anti-infection in ophthalmology and otorhinolaryngology. The applicable population includes patients receiving post-oral surgery care, people undergoing daily oral health care, people receiving skin wound treatment, and patients with local infections in sensitive parts, making it a basic drug choice for multiple clinical departments.

The global market size of cetylpyridinium chloride exceeds USD 300 million, with a compound annual growth rate of 6.2% in the past five years. The core growth drivers come from the continuous expansion of demand for addition in oral care products and the sinking penetration of clinical anti-infection scenarios. The domestic market competition pattern is dominated by generic drug enterprises. At present, more than 20 enterprises have obtained approval for related preparations. Under the background of centralized procurement, the average price reduction of preparations has reached 48%, and the stable supply capacity of upstream API has become one of the core competitive elements for downstream enterprises.

The original research enterprise of cetylpyridinium chloride is Procter & Gamble, with the original brand name Cepacol. Its US compound patent expired in 2006, and the core domestic preparation patent expired in 2014. The main dosage forms approved for the original research include mouthwash (0.1% specification), buccal tablet (2mg specification) and topical disinfectant solution (0.05% specification). All related dosage forms have been included in the FDA Reference Listed Drug Catalog, and the domestic mouthwash dosage form has been included in the *Catalog of Reference Listed Drugs for Chemical Drugs*. At present, there are 12 cetylpyridinium chloride API registration entries on the domestic CDE API registration platform, among which 9 have passed the associated review and approval with preparations. The domestically approved and marketed preparation varieties cover 3 categories of mouthwash, buccal tablet and spray, with a total of 27 product specifications. (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 cetylpyridinium chloride API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the regulatory requirements of the Chinese Pharmacopoeia and FDA, and can fully support the reference standard needs in the whole process of API R&D, quality research and declaration.