| Dibasic sodium phosphate anhydrous USP/Ph.Eur/BP PARENTEX PLUS 500GM | |||
| I1610SG500 | 41839B112IW | ||
| USP/Ph.Eur/BP PARENTEX PLUS | 41839B1 | ||
| 7558-79-4 | 98939 | ||
| Na2HPO4 | September 2023 | ||
| 141.96 | August 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | White powder that readily absorbs moisture. | White powder that readily absorbs moisture. |
| 2 | Solubility | Complies | Freely soluble in water; insoluble in alcohol |
| 3 | Identification (By chemical test) | Complies | Solution should slightly alkaline. |
| 4 | Identification (By Loss on drying) | 0.4% | NMT 1.0% |
| 5 | Identification (Sodium) | Complies | A dense precipitate should form. |
| 6 | Identification (Phosphate 1) | Complies | With silver nitrate solution neutral solution should yield yellow precipitate that soluble in 2N nitric acid and 6 N ammonium hydroxide. |
| 7 | Identification (Phosphate 2) | Complies | With ammonium molybdate solution, acidified solutions should yield a yellow precipitate that 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% |
| 11 | Monosodium Phosphate | Less than 2.5% | NMT 2.5% |
| 12 | Insoluble Substances | 0.03% | NMT 0.4% |
| 13 | Appearance of solution | Complies | Solution should be clear and colourless. |
| 14 | Chlorides | Less than 200ppm | NMT 200 ppm |
| 15 | Sulphate (SO4) | Less than 500ppm | NMT 500 ppm |
| 16 | Arsenic (As) | Less than 16 ppm | NMT 16ppm |
| 17 | Reducing substances | Complies | The colour of the permanganate should not be completely discharge. |
| 18 | Iron(Fe) | Less than 20ppm | NMT 20 ppm |
| 19 | Loss on drying at 130°C | 0.4% | NMT 1.0% |
| 20 | Total aerobic microbial count | 30 CFU/gm | NMT 100 CFU/gm |
| 21 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 22 | E.coli | Absent/gm | Should be absent /gm |
| 23 | Salmonella | Absent/10 gm | Should be absent /10 gm |
| 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, 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.
