| Dibasic sodium phosphate anhydrous USP/Ph.Eur/BP PARENTEX PLUS 5KG | |||
| I1610SR500 | 46740B118GY | ||
| USP/Ph.Eur/BP PARENTEX PLUS | 46740B1 | ||
| 7558-79-4 | 114266 | ||
| Na2HPO4 | July 2025 | ||
| 141.96 | June 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Appearance/Description | White powder that readily absorbs moisture. | White or almost White powder that readily absorbs moisture. | USP/Ph.Eur/BP |
| 2 | Solubility | Complies | Freely soluble in water; insoluble in alcohol (ethanol 96%) | USP/Ph.Eur/BP |
| 3 | Identification (By chemical test) | Complies | Solution should slightly alkaline. | Ph.Eur/BP |
| 4 | Identification (By Loss on drying) | 0.4% | NMT 1.0% | Ph.Eur/BP |
| 5 | Identification (Sodium) | Complies | A dense precipitate should form. | USP/Ph.Eur/BP |
| 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. | USP |
| 7 | Identification (Phosphate 2) | Complies | With ammonium molybdate solution, acidified solutions should yield a yellow precipitate that should soluble in 6N ammonium hydroxide. | USP |
| 8 | Identification (Phosphate 3) | Complies | A yellow colour should develop | Ph.Eur/BP |
| 9 | Assay (on dry basis) | 99.9% | 98.0% - 100.5% | USP |
| 10 | Assay (Dried substance) | 100.0% | 98.0% - 101.0% | Ph.Eur/BP |
| 11 | Monosodium Phosphate | Less than 2.5% | NMT 2.5% | Ph.Eur/BP |
| 12 | Insoluble Substances | 0.1% | NMT 20 mg (NMT 0.4%) | USP |
| 13 | Appearance of solution | Complies | Solution should be clear and colourless. | Ph.Eur/BP |
| 14 | Chlorides | Less than 200 ppm | NMT 200 ppm | Ph.Eur/BP |
| 15 | Sulphate (SO4) | Less than 500 ppm | NMT 500 ppm | Ph.Eur/BP |
| 16 | Arsenic (As) | Less than 16 ppm | NMT 16ppm | USP |
| 17 | Reducing substances | Complies | The colour of the permanganate should not be completely discharge. | Ph.Eur/BP |
| 18 | Iron(Fe) | Less than 20 ppm | NMT 20 ppm | Ph.Eur/BP |
| 19 | Loss on drying | 0.4% | NMT 1.0% | Ph.Eur/BP |
| 20 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm | In-house |
| 21 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm | In-house |
| 22 | E.coli | Absent/gm | Should be absent /gm | In-house |
| 23 | Salmonella | Absent/10 gm | Should be absent /10 gm | In-house |
| 24 | Pseud. aeruginosa | Absent/gm | Should be absent /gm | In-house |
| 25 | Staphylococcus aureus | Absent/gm | Should be absent /gm | In-house |
| 26 | Bile-tolerant gram negative bacteria | Absent/gm | Should be absent /gm | In-house |
| 27 | Bacterial endotoxins | Less than 2.5 EU/gm | NMT 2.5 EU/gm | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur, BP 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.
