| Phenol USP/Ph.Eur PARENTEX 500GM | |||
| P1160SG500 | 42126B518JW | ||
| USP/Ph.Eur PARENTEX | 42126B5 | ||
| 108-95-2 | 98682 | ||
| C6H5OH | October 2023 | ||
| 94.11 | September 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Colorless crystalline mass. has a characteristic odor. Gradually darkens on exposure to light and air, deliquescent. | Colorless to light pink or faintly yellowish, interlaced or separate needle-shaped crystals or white to light pink, crystalline mass. has a characteristic odor. Gradually darkens on exposure to light and air,deliquescent.. |
| 2 | Solubility | Complies | Soluble in water, very soluble in alcohol, in ethanol (96%) in glycerin, in chloroform, in ether, in methylene chloride and in fixed and volatile oils; sparingly soluble in mineral oil. |
| 3 | Identification (By chemical test 1) | Complies | A white precipitate should form which should dissolve at first but become permanent as more of the reagent added |
| 4 | Identification (By chemical test 2) | Complies | A blue color should develop and become progressively more intense |
| 5 | Identification (By chemical test 3) | Complies | A violet color should produce which should disappear on additoin 5ml of 2-propanol |
| 6 | Assay (on Anhydrous basis) | 99.7% | 99.0%-100.5% |
| 7 | Limit of Nonvolatile residue /Residue on evaporation | 0.02% | NMT 0.05% ; NMT 2.5mg |
| 8 | Clarity of solution and reaction | Complies | A solution should be clear and neutral or acid to litmus paper. |
| 9 | Appearance Solution | Complies | Solution should be clear and not more intensely coloured than reference solution B6. |
| 10 | Acidity | Complies | Yellow solution |
| 11 | Congealing temperature | 40°C | NLT 39°C |
| 12 | Freezing point | 41.0°C | NLT 39.5°C |
| 13 | Water | 0.1% | NMT 0.5% |
| 14 | Total aerobic microbial count | Less than 1000 CFU/ml | NMT 1000 CFU/ml |
| 15 | Total Yeast and mold count | Less than 1000 CFU/ml | NMT 1000 CFU/ml |
| 16 | Becterial endotoxins test | Less than 0.2 EU/mg | NMT 0.2 EU/mg |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur SPECIFICATION.
FINAR provides this analytical report in good faith and to the best of its knowledge. It should not be substituted for the users own raw material quality control.
| Tested By (Chemist - Quality Control) | Approved By (Head - Quality Control) |
Computer Generated Report - Does not require Signature.
