| Benzyl alcohol CPH8 PARENTEX PLUS 2LT | |||
| P5290LC200 | 40566H507DW | ||
| CPH8 PARENTEX PLUS | 40566H5 | ||
| 100-51-6 | 93746 | ||
| C6H5CH2OH | April 2023 | ||
| 108.14 | March 2025 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | Clear, colorless, oily liquid. Boils at 206°C, without decomposition. Is neutral to litmus. Specific gravity is 1.045. | Clear, colorless, oily liquid. Boils at about 206°C, without decomposition. Is neutral to litmus. Specific gravity is between 1.042 an 1.047. |
| 2 | Solubility | Complies | Soluble in water, miscible with ethanol (96%) and with fatty and essential oils with ether and with chloroform. Freely soluble in 50% alcohol. |
| 3 | Relative density | 1.045 | 1.043-1.049 |
| 4 | Identification by IR | Complies | The IR absorption spectra of a substance should concomitant with the corresponding standard |
| 5 | Appearance of Solution | Complies | The solution is clear and colorless. |
| 6 | Clarity of solution | Complies | The sample solution shows the same clarity as that of water or its opalescence is not more prononced than that of reference suspension 1. |
| 7 | Color of solution | Complies | The sample solution has color of water. |
| 8 | Refractive index (20°C ± 0.5°C) | 1.541 | 1.538-1.541 |
| 9 | Assay | 99.6% | 98.0% - 100.5% |
| 10 | Acidity | Complies | NMT 1 mL of 0.1 M sodium hydroxide is required to change the color of the indicator to pink. |
| 11 | Fats & Fixed oils (Peroxide value) | 3.5 | NMT 5 |
| 12 | Residue on evaporation | 0.006% | NMT 0.05% |
| 13 | Related substances: Benzaldehyde | 0.005% | NMT 0.05% |
| 14 | Related substances: Cyclohexylmethanol | Not detected | NMT 0.10% |
| 15 | Related substances: Sum of the areas of all other peaks with a relative retention time less than that of Benzyl alcohol | 0.001% | NMT 0.02% |
| 16 | Related substances : Sum of peaks with a relative retention greater than that of benzyl alcohol | 0.002% | NMT 0.2% |
| 17 | Related substances: Disregard limit | 0.0001% | 0.0001% |
| 18 | Benzene | Not detected | NMT 0.0002% |
| 19 | Chlorobenzene (C6H5Cl) | Not detected | NMT 0.01% |
| 20 | Toluene(C6H5CH3) | Not detected | NMT 0.01% |
| 21 | Water | 0.02% | NMT 0.1% |
| 22 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 23 | Total combined mold and yeasts count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 24 | Bacterial endotoxin | Less than 2.5 EU/mL | NMT 2.5 EU/mL |
| 25 | E.coli | Absent/gm | should be Absent/gm |
| 26 | Salmonella | Absent/ 10gm | should be Absent/ 10gm |
| 27 | Pseud. aeruginosa | Absent/gm | should be Absent/gm |
| 28 | Bile-tolerant gram negative bacteria | Absent/gm | should be Absent/gm |
| 29 | Candida albicans | Absent/gm | should be Absent/gm |
| 30 | Staphylococcus aureus | Absent/gm | should be Absent/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, Ph.Eur, BP, JP 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.
