| Dibasic sodium phosphate anhydrous CPH8 PARENTEX PLUS 5KG | |||
| I5610SR500 | 43559H523EX | ||
| CPH8 PARENTEX PLUS | 43559H5 | ||
| 7558-79-4 | 106909 | ||
| Na2HPO4 | May 2024 | ||
| 141.96 | April 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | White powder that readily absorbs moisture and free from visible extraneous matter. | White powder that readily absorbs moisture and free from visible extraneous matter |
| 2 | Solubility | Complies | Freely soluble in water; insoluble in alcohol |
| 3 | Identification (By chemical test) | Complies | Solution should slightly alkaline |
| 4 | Identification (By Loss on drying) | 0.11% | NMT 1.0% |
| 5 | Identification (Sodium) | Complies | A dense precipitate should form |
| 6 | Identification (Phosphate 1) | Complies | With silver nitrate solution neutral solution should yield yellow precipitate that soluble in 2N nitric acid and 6 N ammonium hydroxide |
| 7 | Identification (Phosphate 2) | Complies | With ammonium molybdate solution, acidified solutions should yield a yellow precipitate that should soluble in 6N ammonium hydroxide |
| 8 | Identification (Phosphate 3) | Complies | A yellow colour should develop |
| 9 | Assay (on dry basis) | 99.61% | 98.0% - 100.5% |
| 10 | Assay (on dried basis) | 99.61% | 98.0% - 101.0% |
| 11 | Monosodium Phosphate | Less than 2.5% | NMT 2.5% |
| 12 | Water insoluble substances | 0.016% | NMT 0.05% |
| 13 | Appearance of solution | Complies | Solution should be clear and colourless |
| 14 | Chlorides | Less than 0.001% | NMT 0.001% |
| 15 | Chlorides (Cl) | Less than 200 ppm | NMT 200 ppm |
| 16 | Sulfate | Less than 0.01% | NMT 0.01% |
| 17 | Sulfates (SO4) | Less than 500 ppm | NMT 500 ppm |
| 18 | Arsenic | Less than 2 ppm | NMT 2ppm |
| 19 | Reducing substances | Complies | The solution should remain purplish red colour |
| 20 | Iron(Fe) | Less than 0.002% | NMT 0.002% |
| 21 | Loss on drying at 130°C | 0.11% | NMT 1.0% |
| 22 | Loss on drying (105 °C, 4 hrs) | 0.1% | NMT 1.0% |
| 23 | Alkalinity | 9.2 | 9.0-9.4 |
| 24 | Carbonate | Complies | No effervescence should produce |
| 25 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 26 | Total Yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 27 | Escherichia coli | Absent/gm | Should be absent /gm |
| 28 | Pseud. aeruginosa | Absent/gm | Should be absent /gm |
| 29 | Staphylococcus aureus | Absent/gm | Should be absent /gm |
| 30 | Bile-tolerant gram negative bacteria | Absent/gm | Should be absent /gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur,CP SPECIFICATION.
Actylis 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.
