INTRODUCTION
Cetylpyridinium chloride is the chloride salt form of cetylpyridinium, a quaternary ammonium with broad-spectrum antimicrobial activity. Upon topical administration, cetylpyridinium chloride is positively charged and reacts with the negatively charged microbial cell surfaces, thereby destroying the integrity of the cell membrane.
MANUFACTURE
The process involves reacting cetyl chloride with pyridine under nitrogen atmosphere in an autoclave pressure followed by agitation.
| Synonym | Hexadecylpyridinium chloride monohydrate |
| CAS no. | 6004-24-6 |
| EINECS No | 204-593-9 |
| Molecular formula | C21H38ClN · H2O |
| Molecular weight | 358.00 g/mol |
| Structure |  |
APPLICATIONS
| Used as an active ingredient in mouthwashes, toothpastes, lozenges, throat sprays, breath sprays, and nasal sprays. In these products, it generally mediates an antiseptic activity and protective action against dental plaque and reducing gingivitis. |
| Used on raw and fully cooked foods including, poultry, red meat, fish and shellfish, eggs, fruits, vegetables, cereal grains, nutmeats, and dairy products as an antimicrobial agent at levels not to exceed 1.0%. |
| It has also been used as an ingredient in certain pesticides. |
SPECIFICATIONS…USP
| Test | Unit | Specification |
|---|---|---|
| Description | – | White to almost-white powder, having a slight, characteristic odour. |
| Solubility | – | Very soluble in water, alcohol and chloroform; slightly soluble in benzene and ether. |
| Identification | To comply with USP tests (A,B & C) | |
| A. IR test | – | Positive |
| B. HPLC test | – | Positive |
| C. Chloride test | – | Positive |
| Acidity | – | Not more than 2.5 ml of 0.02N NaOH solution is required for neutralization. |
| Residue on ignition | % | NMT 0.20 |
| Organic impurities | ||
| 1. Myristylpyridinium | % | NMT 0.45 |
| 2. Stearylpyridinium | % | NMT 0.15 |
| 3. Any unspecified Impurity | % | NMT 0.1 |
| 4.Total impurities | % | NMT 1.0 |
| Water determination | % | 4.5 to 5.5 |
| Assay (on anhydrous basis) | % | Cetyl pyridinium chloride contains NLT 98.0 and NMT 102.0 of C21H38ClN. |
PACKING
25 kg Fiber drum.
STORAGE
Keep containers tightly closed in a dry, cool and well-ventilated place. Store at room temperature.
CERTIFICATION
WHO-GMP and WC
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