| Metacresol CDMF 500ML | |||
| 93505LM500 | 34118D220BU | ||
| CDMF | 34118D2 | ||
| 108-39-4 | 72548 | ||
| CH3C6H4OH | February 2021 | ||
| 108.14 | January 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Colourless, highly refrective liquid, becoming darker with age and on exposure to light. A saturated solution of it is neutral to litmus. | Colorless or yellowish to brownish-yellow or pinkish, highly refractive liquid, becoming darker with age and on exposure to light. A saturated solution of it is neutral or only slightly acid to litmus (USP/Ph.Eur) |
| 2 | Solubility | Passes | Sparingly soluble in water, usually forming a cloudy solution; dissolves in solutions of fixed alkali hydroxides. Miscible with alcohol, with ether with glycerin, with ethanol (96%) and with methylene chloride (USP / Ph.Eur) |
| 3 | Identification A (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding stanard (USP/Ph.Eur) |
| 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 (USP) |
| 5 | Relative density | 1.03 | About 1.03 (Ph.Eur) |
| 6 | Melting point | 11.2°C | About 11°C (Ph.Eur) |
| 7 | Boiling point | 203°C | About 202°C (Ph.Eur) |
| 8 | Appearance of solution | Passes | Freshly prepared solution should not more opalescent than reference suspension III and not more intensely colored than reference solution BY7 (Ph.Eur) |
| 9 | Assay (By GC) | 99.84% | 98.0%-102.0% (USP) |
| 10 | Organic Impurities / Related substances (Orthocresol) | Not detected | Not more than 0.5% (USP/Ph.Eur) |
| 11 | Organic Impurities / Related substances (Paracresol) | 0.01% | Not more than 0.5% (USP/Ph.Eur) |
| 12 | Organic Impurities/ Related substances (Any unspecified impurity) | 0.01% | Not more than 0.1% (USP/Ph.Eur) |
| 13 | Organic Impurities / Related substances (Total impurities) | 0.02% | Not more than 1.0% (USP/Ph.Eur) |
| 14 | Clarity of Solution A (By Chemical Test) | Passes | A clear solution (USP) |
| 15 | Clarity of Solution B (By Chemical Test) | Passes | A clear solution (USP) |
| 16 | Acidity | 0.24ml of 0.01 m Sodium hydroxide | Not more than 0.5ml of 0.01 M sodium hydroxide should require to change the colour of the indicator to yellow (Ph.Eur) |
| 17 | Residue on evaporation | 0.02% | 0.1% max (Ph.Eur) |
| 18 | Bacterial endotoxins | Less than 0.5 EU/mg | 0.5 EU/mg (In-house) |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP AND Ph.Eur SPECIFICATION AND CDE REGISTRATION NO. F20190000234.
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.
