| Dibasic sodium phosphate dodecahydrate USP/Ph.Eur/BP PARENTEX PLUS 500G | |||
| I1612SG500 | 45621B108CY | ||
| USP/Ph.Eur/BP PARENTEX PLUS | 45621B1 | ||
| 10039-32-4 | 110734 | ||
| Na2HPO4.12H2O | March 2025 | ||
| 358.14 | February 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | Colorless, transparent crystals, very efflorescent. | Colorless, transparent crystals, very efflorescent | USP/Ph.Eur/BP |
| 2 | Solubility | Complies | Freely soluble in water; practically insoluble in ethanol (96%) | USP/In-house |
| 3 | Identification (By chemical test) | Complies | Solution should be slightly alkaline | Ph.Eur/BP |
| 4 | Identification (By Loss on drying) | 60.6% | 57.0% -61.0% | USP/Ph.Eur/BP |
| 5 | Identification (Sodium) | Complies | A dense precipitate should form. | USP/Ph.Eur/BP |
| 6 | Identification (Phosphate 1) | Complies | A yellow precipitate soluble in 2N nitric acid and in 6 N ammonium hydroxide should form. | USP |
| 7 | Identification (Phosphate 2) | Complies | With ammonium molybdate solution, acidified solutions should yield a yellow precipitate which should soluble in 6N ammonium hydroxide. | USP |
| 8 | Identification (Phosphate 3) | Complies | A yellow color should develop. | Ph.Eur/BP |
| 9 | Assay (on dried basis) | 98.4% | 98.0% - 100.5% | USP |
| 10 | Assay | 102.2% | 98.5% - 102.5% | Ph.Eur/BP |
| 11 | Insoluble Substances | 0.02% | NMT 20mg (NMT 0.4%) | USP |
| 12 | Appearance of solution | Complies | Clear and colorless solution. | Ph.Eur/BP |
| 13 | Reducing substances | Complies | The color of the permanganate should not completely discharge | Ph.Eur/BP |
| 14 | Monosodium Phosphate | Less than 2.5% | NMT 2.5% | Ph.Eur/BP |
| 15 | Chlorides | Less than 200ppm | NMT 200ppm | Ph.Eur/BP |
| 16 | Sulphate (SO4) | Less than 500ppm | NMT 500ppm | Ph.Eur/BP |
| 17 | Arsenic (As) | Less than 2ppm | NMT 2ppm | Ph.Eur/BP |
| 18 | Iron(Fe) | Less than 20ppm | NMT 20ppm | Ph.Eur/BP |
| 19 | Loss on drying at 130°C | 60.6% | 57.0% -61.0% | USP/Ph.Eur/BP |
| 20 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm | In House |
| 21 | Total combined yeast and mould count | Less than 10 CFU/gm | NMT 10 CFU/ gm | In House |
| 22 | Bacterial endotoxin test | Less than 2.5 EU/gm | NMT 2.5 EU/gm | In House |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur, BP 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.
