| Monobasic sodium phosphate monohydrate USP/BP PARENTEX PLUS 25KG | |||
| I1591SK025 | 43063G404CX | ||
| USP/BP PARENTEX PLUS | 43063G4 | ||
| 10049-21-5 | 101901 | ||
| NaH2PO4.H2O | March 2024 | ||
| 137.99 | February 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | Colorless crystalline powder. Its solutions are acid to litmus and effervesce with sodium carbonate | Colorless crystals or a white crystalline powder. Its solutions are acid to litmus and effervesce with sodium carbonate. |
| 2 | Solubility | Complies | Very soluble in water; very slightly soluble in ethanol (96%). practically insoluble in alcohol. |
| 3 | Identification (By chemical test) | Complies | Solution should be slightly acid. |
| 4 | Identification (Phosphate 1) | Complies | A neutral solution should yield yellow precipitate with silver nitrate solution that soluble in 2N nitric acid and 6 N ammonium hydroxide. |
| 5 | Identification (Phosphate 2) | Complies | With ammonium molybdate solution, acidified solutions should yield a yellow precipitate with ammonium molybdate solution which should soluble in 6N ammonium hydroxide. |
| 6 | Identification (Sodium 1) | Complies | A dense precipitate should form. |
| 7 | Identification D (By Loss on drying) | 12.9% | 11.5% - 14.5% |
| 8 | Acidity / PH | 4.31 | pH of the solution should be between 4.2 and 4.5 |
| 9 | Clarity and colour of solution | Complies | Clear and colorless solution |
| 10 | Arsenic (As) | Less than 2 ppm | NMT 2 ppm |
| 11 | Iron (Fe) | Less than 10 ppm | NMT 10 ppm |
| 12 | Sulphate (SO4) | Less than 300 ppm | NMT 300 ppm |
| 13 | Chloride (Cl) | Less than 140 ppm | NMT 140 ppm |
| 14 | Reducing substances | Complies | The solution retains a slight red color. |
| 15 | Loss on drying at 130°C | 12.9% | 11.5% - 14.5% |
| 16 | Water | 13.3% | 10.0% - 15.0% |
| 17 | Assay (Dried substance) | 99.6% | 98.0% - 100.5% |
| 18 | Insoluble Substances | 0.003% | NMT 0.2% |
| 19 | Aluminium, Calcium and Related Element | Complies | The sample solution should not become turbid when rendered slightly alkaline to litmus paper with 6N ammonium hydroxide. |
| 20 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 21 | Total combined yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 22 | Escherichia coli | Absent/gm | should be Absent/gm |
| 23 | Salmonella | Absent/10gm | should be Absent/ 10gm |
| 24 | Pseud. aeruginosa | Absent/gm | should be Absent/gm |
| 25 | Staphylococcus aureus | Absent/gm | should be Absent/gm |
| 26 | Bile-tolerant gram negative bacteria | Absent/gm | should be Absent/gm |
| 27 | Bacterial endotoxins | 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, 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.
