| Dibasic Sodium Phosphate heptahydrate USP PARENTEX PLUS 500G | |||
| I7614SG500 | 46707F617GY | ||
| USP PARENTEX PLUS | 46707F6 | ||
| 7782-85-6 | 114248 | ||
| Na2HPO4.7H2O | July 2025 | ||
| 268.07 | June 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | White, caked salt. Effloresces in warm, dry air.Its solutions are alkaline to phenolphthalein. A 0.1M solution have a pH 9.1 | Colorless or white, granular or caked salt. Effloresces in warm, dry air. Its solutions are alkaline to phenolphthalein. A 0.1M solution should have a pH about 9. | USP |
| 2 | Solubility | Complies | Freely soluble in water; very slightly soluble in alcohol | USP |
| 3 | Identification A (By Chemical test) | Complies | A dense precipitate should form. | USP |
| 4 | Identification B (By Chemical test 1) | Complies | With silver nitrate solution neutral solution should yield yellow precipitate that soluble in 2N nitric acid and 6 N ammonium hydroxide. | USP |
| 5 | Identification B (By Chemical test 2) | Complies | With ammonium molybdate solution, acidified solutions should yield a yellow precipitate that should soluble in 6N ammonium hydroxide. | USP |
| 6 | Assay (on dried basis) | 99.9% | 98.0% - 100.5% (Na2HPO4) | USP |
| 7 | Insoluble Substances | 0.01% | NMT 0.4% | USP |
| 8 | Chlorides | Less than 0.06% | NMT 0.06% | USP |
| 9 | Sulfate (SO4) | Less than 0.2% | NMT 0.2% | USP |
| 10 | Arsenic (As) | Less than 1.5 ppm | NMT 1.5ppm | USP |
| 11 | Loss on drying,130°C | 46.6% | 43.0% - 50.0% | USP |
| 12 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm | In-house |
| 13 | Total Yeast & mold count | Less than 10 CFU/gm | NMT 10 CFU/gm | In-house |
| 14 | Escherichia coli | Absent/gm | should be absent/gm | In-house |
| 15 | Salmonella | Absent/10 gm | should be absent/ 10gm | In-house |
| 16 | Pseud. aeruginosa | Absent/gm | should be absent/gm | In-house |
| 17 | Staphylococcus aureus | Absent/gm | should be absent/gm | In-house |
| 18 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm | In-house |
| 19 | Bacterial endotoxins | Less than 2.5 EU/mg | NMT 2.5 EU/mg | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP 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.
