The document compares test results for Kumar's triclosan sample to a Chinese sample. Kumar's sample met all USP specification requirements for assay, water, residue on ignition, heavy metals, and melting point. The Chinese sample failed for 2,8-dichlorodibenzo-p-dioxin and 2,4,8-trichlorodibenzofuran levels, which exceeded their maximum allowable limits under USP specifications. Further tests for other impurities were not conducted on the Chinese sample due to the initial failures.

1. KUMAR ORGANIC PRODUCTS LIMITED
Comparative Test Report
Product Name: Triclosan
Sample Qty : 40gms
Code No. : UVWCHN – 01
Item of Test Requirement Chinese Chinese Sample as Kumar’s
of USP – 34 Sample per Party’s Test Sample
Analysed in Report Received
Kumar (No. 20020110)
Assay 99.0 – 100% 99.78% 99.85% 99.84%
Water NMT 0.1% < 0.1% 0.05% <0.1%
Residue on ignition NMT 0.1% < 0.1% 0.05% <0.1%
Heavy metals NMT 20 ppm < 20ppm 0.8 ppm <20ppm
Melting Point 57 + 1OC 56.5-57.8OC 56.5 – 57.8 OC 58OC
4 – Chlorophenol < 50 ppm 0.8668 ppm <0.001ng/kg 0.8132 ppm
2,4 – Dichlorophenol < 10 ppm 3.9470 ppm <0.001ng/kg 2.3111ppm
2,8 – Dichlorodibenzofuran < 0.5 ppm 0.0379 ppm <0.001ng/kg 0.0120 ppm
2,8 – Dichlorodibenzo-p-dioxin < 0.25 ppm 0.4240 ppm Not Specified 0.0582 ppm
2,4,8 – Trichlorodibenzofuran < 0.5 ppm 3.1660 ppm <0.001ng/kg 0.1069 ppm
1,3,7 – Trichlorodibenzo-p- < 0.25 ppm Not detected Not Specified Not detected
dioxin
2,3,7,8 – < 1ppt Not Analysed <0.001ng/kg <1ppt
Tetrachlorodibenzofuran
2,3,7,8 – Tetrachlorodibenzo- < 1ppt Not Analysed <0.001ng/kg <1ppt
p-dioxin
Remarks:
The above table shows that the Chinese sample doesn’t conform to USP Specification as it fails
in the initial analysis through HPLC as below.
1) 2,8 – Dichlorodibenzo-p-dioxin should be < 0.25 ppm, but obtained was 0.4240 ppm which is not
comparable with Kumar’s Triclosan sample
2) 2,4,8 – Trichlorodibenzofuran should be < 0.5 ppm, but obtained was 3.1660 ppm which is
approximately 30 times more than Kumar’s sample.
Since the sample was failing in HPLC, it has not taken for further analysis for impurities of
2,3,7,8TCDF & 2,3,7,8TCDD through GC-MS as higher concentration of these impurities will
cause problem to the column. It was observed that in the test report No. 20020110 all the
Organic impurities were reported as <0.001ng/kgwhich doesn’t conform to the USP
Specification. 2,8 – Dichlorodibenzo-p-dioxin and 1,3,7 – Trichlorodibenzo-p-dioxin were
not specified in the test report received along with the sample.