KUMAR ORGANIC PRODUCTS LIMITED Comparative Test Report

Product Name: Triclosan Sample Qty : 40gms Code No. : UVWCHN – 01

Item of Test Requirement of USP – 34

Chinese Sample Analysed in Kumar

Chinese Sample as per Party’s Test Report Received (No. 20020110)

Kumar’s Sample

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-dioxin

< 0.25 ppm Not detected Not Specified Not detected

2,3,7,8 – Tetrachlorodibenzofuran

< 1ppt Not Analysed <0.001ng/kg <1ppt

2,3,7,8 – Tetrachlorodibenzo-p-dioxin

< 1ppt Not Analysed <0.001ng/kg <1ppt

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.