| Dibasic Sodium Phosphate Heptahydrate USP PARENTEX 500G | |||
| P7614SG500 | 46707H217GY | ||
| USP PARENTEX | 46707H2 | ||
| 7782-85-6 | 114250 | ||
| Na2HPO4.7H2O | July 2025 | ||
| 268.07 | June 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | White caked salt. | Colorless or white, granular or caked salt. | USP |
| 2 | Solubility | Complies | Freely soluble in water; very slightly soluble in alcohol. | USP |
| 3 | Identification A (Sodium) | Complies | A dense precipitate should form. | USP |
| 4 | Identification B (Phosphate 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 (Phosphate 2) | Complies | With ammonium molybdate solution, acidified solution should yield a yellow precipitate that should be soluble in 6 N ammonium hydroxide. | USP |
| 6 | Appearance of solution | Complies | Solution S should be clear and colourless. | In-house |
| 7 | Reducing substances | Complies | The Colour of the permanganate should not be completely discharged. | In-house |
| 8 | Insoluble Substances | 0.01% | NMT 0.4% | USP |
| 9 | Chlorides | Less than 0.06% | NMT 0.06% | USP |
| 10 | Sulfates | Less than 0.2% | NMT 0.2% | USP |
| 11 | Arsenic | Less than 16 ppm | NMT 16 ppm | USP |
| 12 | Iron | Less than 20 ppm | NMT 20 ppm | In-house |
| 13 | Loss on drying at 130°C | 46.6% | 43.0%-50.0% | USP |
| 14 | pH | 9.1 | 8.7-9.3 | In-house |
| 15 | Heavy metal (as Pb) | Less than 10 ppm | NMT 10 ppm | In-house |
| 16 | Assay (on dried basis) | 99.9% | 98.0%-100.5% | USP |
| 17 | Bacterial endotoxins | Less than 2.5 IU/g | NMT 2.5 IU/g | Im-house |
| 18 | Total Microbial Count | Less than 100 cfu/g | NMT 100 cfu/g | In-house |
| 19 | Total Yeast and mold count | Less than 100 cfu/g | NMT 100 cfu/g | 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.
