| Metacresol USP/Ph.Eur/BP PARENTEX PLUS 100ML | |||
| I0505LM100 | 43232B129CX | ||
| USP/Ph.Eur/BP PARENTEX PLUS | 43232B1 | ||
| 108-39-4 | 102570 | ||
| CH3C6H4OH | March 2024 | ||
| 108.14 | February 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Yellowish, highly refrective liquid, becoming darker with age and on exposure to light. | Colourless or yellowish to brownish-yellow or pinkish, highly refrective liquid, becoming darker with age and on exposure to light. |
| 2 | Solubility | Complies | Sparingly soluble in water, usually forming a cloudy solution; dissolves in solutions of fixed alkali hydroxides. Miscible with alcohol, with ether, with glycerine,with ethanol (96%) and with methylene chloride. |
| 3 | Identification A (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard. |
| 4 | Identification B (By GC Chromatogram) | Complies | The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. |
| 5 | Relative density | 1.031 | About 1.03 |
| 6 | Melting point | 11.3°C | About 11 °C |
| 7 | Boiling point | 202.6°C | About 202 °C |
| 8 | Appearance of Solution | Complies | Freshly prepared solution should not more opalescent than reference suspension III and not more intensely coloured than reference solution BY7. |
| 9 | Assay (By GC) | 99.77% | 98.0% - 102.0% |
| 10 | Organic Impurities / Related substances (Orthocresol) | Not detected | NMT 0.5% |
| 11 | Organic Impurities / Related substances (Paracresol) | 0.06% | NMT 0.3% |
| 12 | Organic Impurities/ Related substances (Any unspecified impurity) | Not detected | NMT 0.1% |
| 13 | Organic Impurities / Related substances (Total impurities) | 0.06% | NMT 1.0% |
| 14 | Clarity of Solution A (By Chemical Test) | Complies | A clear solution |
| 15 | Clarity of Solution B (By Chemical Test) | Complies | A clear solution |
| 16 | Acidity | Complies | Not more than 0.5mL of 0.01 M sodium hydroxide should require to change the colour of the indicator to yellow. |
| 17 | Residue on evaporation | 0.05% | NMT 0.1% |
| 18 | Absorption (400-700 nm) | 0.002 | NMT 0.05 |
| 19 | Toluene content (By GC) | Not detected | NMT 100ppm |
| 20 | Bacterial endotoxins | Less than 0.1 EU/mg | NMT 0.1 EU/mg |
| 21 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 22 | Total Yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur, BP, 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.
