Cetylpyridinium chloride Cetylpyridinium chloride high purity Cetylpyridinium chloride
Cetylpyridinium chloride is a quaternary ammonium cationic surfactant, used in pharmaceutical and cosmetic formulations as an antimicrobial preservative; see Section 10. 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.
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Item |
Standard |
Test Results |
|
Identification |
A.H-NMR:Comply with the structure |
Complies |
|
B.LC-MS:Comply with the structure |
Complies |
||
C.The IR spectrum of sample should be identical with that of reference standard; |
Complies |
||
D.HPLC-ESI-MS |
Complies |
||
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. |
|||
Heavy metals |
≤10 ppm |
<10ppm |
|
Water |
≤1.0% |
0.10% |
|
Sulphated ash |
≤0.5%, determined on 1.0 g. |
0.01% |
|
Related substances |
Unspecified impurities: for each impurity |
≤0.10% |
<0.10% |
Total Impurity |
≤0.5% |
0.18% |
|
Purity |
≥99.0% |
99.70% |
|
Assay |
99.0%~101.0% (anhydrous substance). |
99.80% |
|
Storage |
Preserve in well-closed, light-resistant and airtight containers. |
Complies |
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