This certificate of analysis summarizes the test results for a batch of cetylpyridinium chloride monohydrate powder. All test results were found to comply with specifications, including assays for appearance, identification through IR and UV spectroscopy, melting point, acidity, water content, residue on ignition, heavy metals, pyridine, and assay. The material meets the specifications of the United States Pharmacopeia and is approved for use.
Original Description:
Original Title
COA for CETYLPYRIDINIUM CHLORIDE MONOHYDRATE USP (1)
This certificate of analysis summarizes the test results for a batch of cetylpyridinium chloride monohydrate powder. All test results were found to comply with specifications, including assays for appearance, identification through IR and UV spectroscopy, melting point, acidity, water content, residue on ignition, heavy metals, pyridine, and assay. The material meets the specifications of the United States Pharmacopeia and is approved for use.
This certificate of analysis summarizes the test results for a batch of cetylpyridinium chloride monohydrate powder. All test results were found to comply with specifications, including assays for appearance, identification through IR and UV spectroscopy, melting point, acidity, water content, residue on ignition, heavy metals, pyridine, and assay. The material meets the specifications of the United States Pharmacopeia and is approved for use.
MONOHYDRATE Batch number: SLS/20/CPC/036 Expiry Date: March 2025 Manufacturer Date: April 2020
TEST SPECIFICATION RESULT
Appearance A white or almost white powder. Complies Identification IR spectrum of sample concordant with that a. By IR of with cetylpyridinium chloride working Complies standard. The UV absorption spectrum of the sample b. By UV solution and standard solution should Complies exhibit maxima and minima at the same wavelength.
c. Test for Chlorides Turbidity is produced rather than curly Complies
white precipitate. Melting point 80°c to 84°C 81°C to 84°C Not more than 25ml of 0.02M sodium Acidity Complies hydroxide is required for neutralization. Water Content (KF) 4.5% to 5.5% 4.87% Not more than 0.2% calculated on Residue on Ignition 0.06% anhydrous basis. Heavy Metals Not more than 0.002% Complies The odour of pyridine is not immediately Pyridine Complies perceptible Assay 99.0% to 102% on anhydrous basis 99.8% w/w REMARKS: THE MATERIAL AS PER SPECIFICATIION OF USPE MATERIAL AS PER SPECIFICATIION OF USP 39, NF-34 STORAGE: PRESERVE IN WELL CLOSED CONDITION HANDLING: AS PER PROVIDED SDS Approved by Quality Assurance This document is generated electronically and is valid without signature