| Monobasic potassium phosphate USP-NF/Ph.Eur/BP PARENTEX PLUS 500GM | |||
| I1270SG500 | 41075C113FW | ||
| USP-NF/Ph.Eur/BP PARENTEX PLUS | 41075C1 | ||
| 7778-77-0 | 96506 | ||
| KH2PO4 | June 2023 | ||
| 136.09 | May 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | White crystalline powder. Is odorless and is stable in air. The pH of a solution (1 in 100) is 4.5 | White or almost white, odourless crystals, granular or crystalline or colourless powder. Is odorless and is stable in air. The pH of a solution (1 in 100) is about 4.5. |
| 2 | Solubility | Complies | Freely soluble in water, practically insoluble in ethanol (96%) |
| 3 | Identification A (By Chemical test) | Complies | Solution should be faintly acid |
| 4 | 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. |
| 5 | Identification (Potassium 1) | Complies | White crystalline precipitate should form. |
| 6 | Identification (Potassium 2) | Complies | A yellow or orange-yellow precipitate should form immediately. |
| 7 | Identification (Phosphate 2) | Complies | With ammonium molybdate solution, acidified solutions should yield a yellow precipitate that should soluble in 6N ammonium hydroxide |
| 8 | Appearance of solution | Complies | Clear and colorless solution |
| 9 | pH | 4.42 | 4.2 to 4.5 |
| 10 | Reducing substances | Complies | The color of the permanganate should not be completely discharged |
| 11 | Chlorides | Less than 200 ppm | NMT 200 ppm |
| 12 | Sulfates | Less than 300 ppm | NMT 300 ppm |
| 13 | Arsenic | Less than 2 ppm | NMT 2 ppm |
| 14 | Iron | Less than 10 ppm | NMT 10 ppm |
| 15 | Lead | Not detected | NMT 5 µg/gm |
| 16 | Fluoride(F) | Not detected | NMT 10 µg/gm |
| 17 | Insoluble Substances | 0.007% | NMT 20 mg (0.2%) |
| 18 | Loss on drying | 0.20% | NMT 1.0% |
| 19 | Assay (on dried basis) | 100.1% | 98.0% to 100.5% |
| 20 | Sodium (Na) | 0.0048% | NMT 0.1% |
| 21 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 22 | Total combined yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 23 | E.coli | Absent/gm | should be absent/gm |
| 24 | Salmonella | Absent/10 gm | should be absent/10 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/mg | NMT 2.5 EU/mg |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, 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.
