| Monobasic sodium phosphate anhydrous USP/BP PARENTEX PLUS 500GM | |||
| I1592SG500 | 41054G416FW | ||
| USP/BP PARENTEX PLUS | 41054G4 | ||
| 7558-80-7 | 98059 | ||
| NaH2PO4 | June 2023 | ||
| 119.98 | May 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | White, crystalline powder. Is odorless and is slightly deliquescent. Its solutions are acid to litmus and effervesce with sodium carbonate. | Colorless crystals or white, crystalline powder. Is odorless and is slightly deliquescent. Its solutions are acid to litmus and effervesce with sodium carbonate. |
| 2 | Solubility | Complies | Freely soluble in water; practically insoluble in alcohol. |
| 3 | Identification A (Sodium) | Complies | A dense precipitate should form. |
| 4 | Identification B (Phosphate 1) | Complies | A neutral solution should yield yellow precipitate that soluble in 2N nitric acid and 6 N ammonium hydroxide |
| 5 | Identification B (Phosphate 2) | Complies | With ammonium molybdate solution, acidified solutions should yield a yellow precipitate that should soluble in 6N ammonium hydroxide. |
| 6 | Identification (By chemical test 1) | Complies | Solution should be slightly acid |
| 7 | Identification (By Loss on drying) | 0.6% | NMT 1.0% |
| 8 | Assay (Anhydrous basis) | 98.8% | 98.0% - 103.0% |
| 9 | Assay (Dried substance) | 98.8% | 98.0%-100.5% |
| 10 | Insoluble Substances | 0.003% | NMT 0.2% |
| 11 | Chlorides | Less than 0.014% | NMT 0.014% |
| 12 | Sulfate (SO4) | Less than 0.15% | NMT 0.15% |
| 13 | Aluminium, Calcium and Related Element | Complies | The sample solution should not become turbid when rendered slightly alkaline to litmus paper with 6N ammonium hydroxide. |
| 14 | Arsenic (As) | Less than 2 ppm | NMT 2 ppm |
| 15 | Iron (Fe) | Less than 10 ppm | NMT 10 ppm |
| 16 | Acidity | 4.3 | pH of the solution should be 4.2-4.5 |
| 17 | pH | 4.3 | 4.1 -4.5 |
| 18 | Clarity and colour of solution | Complies | Clear and colorless solution |
| 19 | Water | 0.5% | NMT 2.0% |
| 20 | Loss on drying at 130°C | 0.6% | NMT 1.0% |
| 21 | Reducing substances | Complies | The solution should retain slight red color |
| 22 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 23 | Total Yeast & mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 24 | Escherichia coli | Absent/gm | should be absent/gm |
| 25 | Salmonella | Absent/10 gm | should be absent/10 gm |
| 26 | Pseud. aeruginosa | Absent/gm | should be absent/gm |
| 27 | Staphylococcus aureus | Absent/gm | should be absent/gm |
| 28 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm |
| 29 | 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.
