Cetylpyridinium Chloride

Cetylypyridinium chloride is a white powder with a characteristic odor. It is slightly soapy to the touch.
Supplier CD Formulation
Product # PE-0631
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product1 Excipients for Liquid Dosage Form
Applications Cetylpyridinium chloride is a quaternary ammonium cationic surfactant, used in pharmaceutical and cosmetic formulations as an antimicrobial preservative. It is used therapeutically as an antiseptic agent; used alone or in combination with other drugs for oral and throat care; used in nonparenteral formulations licensed in the UK; and used in oral and inhalation preparations at concentrations of 0.02-1.5.mg. Mouthwashes containing cetylpyridinium chloride have been shown to inhibit plaque formation, although efficacy is variable owing to limited published data.
Safety Cetylpyridinium chloride is used widely in mouthwashes as a bactericidal antiseptic. It is generally regarded as a relatively nontoxic material when used at a concentration of 0.05% w/v, although minor side effects such as mild burning sensations on the tongue have been reported. At higher concentrations, cetylpyridinium chloride may damage the mucous membranes in the mouth. It is harmful when ingested or inhaled. It can cause eye irritation, and is irritant to the respiratory system and the skin. LD50 (rat, IP): 0.006 g/kg LD50 (rat, IV): 0.03 g/kg LD50 (rat, oral): 0.2 g/kg LD50 (rat, SC): 0.25 g/kg LD50 (mouse, IP): 0.01 g/kg LD50 (mouse, oral): 0.108 g/kg LD50 (rabbit, oral): 0.4 g/kg LD50 (rabbit, IV): 0.036 g/kg
Incompatibilities Incompatible with strong oxidizing agents and bases. It is also incompatible with methylcellulose. Magnesium stearate suspensions in cetylpyridinium chloride have been shown to significantly reduce its antimicrobial activity.This is due to the absorption of cetylpyridinium chloride on magnesium stearate.The cetylpyridinium chloride ion also interacts with gelatin, resulting in reduced bioavailability.
Synonyms C16-alkylpyridinium chloride; Cepacol; Cepacol chloride; Ceta- miun; cetylpridinii chloridum; cetyl pyridium chloride; Dobendan; hexadecylpyridinium chloride; 1-hexadecylpyridinium chloride; Medilave; Pristacin; Pyrisept
Category Antimicrobial Preservative; Cationic Surfactant; Solubilizing Agents; Wetting Agents
UNII D9OM4SK49P
Chemical Name 1-Hexadecylpyridinium chloride; 1-Hexadecylpyridinium chloride monohydrate;
Grade Pharmceutical Excipients
Administration route Inhalation and oral
Dosage Form Inhalation and oral preparations
Stability and Storage Conditions Cetylpyridinium chloride is stable under normal conditions. It should be stored in well-closed containers.
Source and Preparation Cetylpyridinium chloride is prepared from cetyl chloride by treatment with pyridine.
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