| Dibasic sodium phosphate dihydrate USP/Ph.Eur/BP PARENTEX 500GM | |||
| P1611SG500 | 42979B221BX | ||
| USP/Ph.Eur/BP PARENTEX | 42979B2 | ||
| 10028-24-7 | 101577 | ||
| Na2HPO4.2H2O | February 2024 | ||
| 177.99 | January 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Colorless crystals. | White powder or colorless crystals. |
| 2 | Solubility | Complies | Freely soluble in water; practically insoluble in ethanol (96%) |
| 3 | Identification (By chemical test) | Complies | Solution should be slightly alkaline |
| 4 | Identification (By Loss on drying) | 19.8% | 19.5% - 21.0% |
| 5 | Identification (Sodium) | Complies | A dense precipitate should form. |
| 6 | Identification (Phosphate 1) | Complies | A yellow precipitate that solution in 2N nitric acid and in 6N ammonium hydroxide should form. |
| 7 | Identification (Phosphate 2) | Complies | With ammonium molybdate solution, acidified solutions should yield a yellow precipitate which should soluble in 6N ammonium hydroxide. |
| 8 | Identification (Phosphate 3) | Complies | A yellow colour should develop. |
| 9 | Assay (on dry basis) | 100.2% | 98.0% - 100.5% |
| 10 | Assay (Dried substance) | 100.2% | 98.0% 101.0% (Na2HPO4) |
| 11 | Insoluble Substances | 0.03% | NMT 0.4% |
| 12 | Appearance of solution | Complies | Clear and colorless solution. |
| 13 | Reducing substances | Complies | The color of the permanganate should not completely discharge |
| 14 | Monosodium Phosphate | Less than 2.5% | NMT 2.5% |
| 15 | Chlorides | Less than 400 ppm | NMT 400ppm |
| 16 | Sulphate (SO4) | Less than 0.1% | NMT 0.1% |
| 17 | Arsenic (As) | Less than 4 ppm | NMT 4ppm |
| 18 | Iron(Fe) | Less than 40 ppm | NMT 40ppm |
| 19 | Loss on drying,130°C | 19.8% | 19.5% - 21.0% |
| 20 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 21 | Total combined mold and yeasts count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 22 | 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, 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.
