QUALITY CONTROL | CERTIFICATE OF ANALYSIS | ||
---|---|---|---|
Name Of Product | TRICLOSAN | BATCH. NO | TCS/DI/018/13-14 |
Analysis Report No. | TCS/ 18 /13-14. | Mfg. Date | AUG - 2013. |
Date of Sampling. | 12 AUG 2013 | Expiry. Date | JULY - 2018. |
Customer Name | ----- | Mfg. license No | G/25/1944. |
Quantity being Dispatched | ---- | Page | 01 – 02. |
Sr. No. | ITEM | SPECIFICATION | RESULT |
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1. | Appearance / colour. | Fine White Crystalline Powder. Melt about 57º C. | White Crystalline Powder. |
2. | Solubility | Practically Insoluble in Water, Soluble in Methanol, Alcohol & Acetone. Slightly Soluble in n Hexane | Complies |
3. | Identification A. IR Absorption. |
A. The IR absorption spectrum of the sample should be concordant with IR absorption spectrum of the Triclosan working standard. | Consistent |
B. GC RT. | B. The retention time of the major peak in Chromatogram of the Assay preparation should corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. | Complies | |
4. | Water | Not More Than (NMT) 0.1% | 0.050% |
5. | Completeness of solution | The Solution Should be Clear | Clear |
6. | Heavy metals | NMT 0.002% | <0.002% |
7. | Related Compound a. Any individual impurity b. Total impurities |
NMT. 0.1% NMT 0.5% |
0.1% 0.5% |
8. | Phenolic impurities a. 2, 4 - Dichlorophenol b. 3 & 4-chlorophenol |
NMT 50ppm NMT 10ppm |
8.654ppm 5.432ppm |
9. | Neutral impurities |
||
a.1,3,7-Trichlorodibenzo-p-Dioxin. | NMT 0.25ppm. | 0.06ppm. | |
b. 2,8-Dichlorodibenzo-p-Dioxin. | NMT 0.50ppm. | 0.4124ppm. | |
c. 2,8 - Dichlorodibenzo-furan. | NMT 0.25ppm. | Below detection limit. | |
d. 2,4,8-Trichlorodibenzofuran. | NMT 0.5ppm. | 0.1634ppm. | |
e. 2,3,7,8 -Tetrachlorodibenzo-p-Dioxin. | NMT 1ppt. | ≤ 1.0ppt. | |
f. 2,3,7,8 - Tetrachlorodibenzofuran. | NMT 1ppt. | ≤ 1.0ppt. | |
10. | Assay (Purity) on anhydrous basis) | NLT 97% & NMT 103%. | 99.82%. |
11. | Heavy metal | ||
Ash. | Less than or Equal to 2mg/kg. | ≤ 0.2%. | |
Arsenic. | Less than or Equal to 2mg/kg. | 0.100mg/kg. | |
Antimony | Less than or Equal to 10mg/kg. | 7.09 mg/kg. | |
Cadmium. | Less than or Equal to 5mg/kg. | ≤ 5 mg/kg. | |
Chromium. | Less than or Equal to 2mg/kg. | 1.03 mg/kg. | |
Copper. | Less than or Equal to 10mg/kg. | ≤ 10 mg/kg. | |
Lead. | Less than or Equal to 10mg/kg. | ≤ 10 mg/kg. | |
Mercury. | Less than or Equal to 1mg/kg. | 0.020 mg/kg. | |
Nickel. | Less than or Equal to 10mg/kg. | 0.23mg/kg. | |
12. | Residual solvent a. N-Hexane. b. Tetrachloroethylene. |
NMT 290ppm. NMT 500ppm. |
≤ 290ppm. ≤ 500ppm. |
13. | Additional test | ||
a. Loss on Drying. | NMT 0.1%. | 0.025%. | |
b. Iron. | NMT 10ppm. | ≤ 10ppm. | |
c. Odour. | Slightly characteristic. | Complies. | |
d. Residue on Ignition. | NMT 0.1%. | 0.012%. |