| Sodium benzoate USP-NF/Ph.Eur/BP PARENTEX PLUS 5KG | |||
| I1540SR500 | 41510C109HW | ||
| USP-NF/Ph.Eur/BP PARENTEX PLUS | 41510C1 | ||
| 532-32-1 | 97001 | ||
| C6H5COONa | August 2023 | ||
| 144.11 | July 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | White, odorless, crystalline powder, slightly hygroscopic. | White, odorless, crystalline or granular powder or flakes, slightly hygroscopic |
| 2 | Solubility | Complies | freely soluble in water. |
| 3 | Identification (Reaction (b) for Benzoate | Complies | A white sublimate should deposite on the inner wall of the tube. |
| 4 | Identification (Reaction (c) for Benzoate ) | Complies | Melting point should be 120°C to 124°C after crystallization |
| 5 | Identification (Reaction (a) for Sodium) | Complies | A dense white precipitate should form |
| 6 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard |
| 7 | Identification (By Chromatography) | Complies | The retention time of the major peak of the sample solution should correspond to that of the standard solution as obtained in the Assay |
| 8 | Appearance of solution | Complies | Solution should be clear and not more intensely colored than reference solution Y6. |
| 9 | Halogenated compounds: Ionized chlorine | Less than 200 ppm | NMT 200 ppm |
| 10 | Halogenated compounds: Total chlorine | Less than 300 ppm | NMT 300 ppm |
| 11 | Loss on drying at 105°C | 0.6% | NMT 2.0% |
| 12 | Water | 0.6% | NMT 1.5% |
| 13 | Assay (By Titration) | 99.8% | 99.0% - 100.5%(dried substance) |
| 14 | Assay(HPLC) | 99.74% | 99.0% - 101.0% (Anhydrous basis) |
| 15 | Acidity | Complies | Not more than 0.2 ml of 0.1 M sodium hydroxide should require to change the color of the indicator. |
| 16 | Alkalinity | Complies | The pink color produced, if any, should discharge by the addition of 0.20 mL of 0.10N sulfuric acid |
| 17 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 18 | Total Yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 19 | E.coli | Absent/gm | should be Absent/gm |
| 20 | Pseud. aeruginosa | Absent/gm | should be Absent/gm |
| 21 | Staphylococcus aureus | Absent/gm | should be Absent/gm |
| 22 | Bile-tolerant gram negative bacteria | Absent/gm | should be Absent/gm |
| 23 | Salmonella | Absent/10 gm | should be Absent/10 gm |
| 24 | Bacterial endotoxin test | Less than 2.5 EU/gm | NMT 2.5 EU/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, 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.
