| Sodium dihydrogen phosphate dihydrate Cell culture 250GM | |||
| C7590SG250 | 87909H816CV | ||
| Cell culture | 87909H8 | ||
| 13472-35-0 | 84014 | ||
| NaH2PO4.2H2O | March 2022 | ||
| 156.01 | February 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Colorless 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 | Passes | freely soluble in water; practically insoluble in alcohol. |
| 3 | Assay | 99.5% | 98.0% - 100.5% |
| 4 | Identification A (By Chemical test) | Passes | Solution should be slightly acid. |
| 5 | Identification A (Sodium) | Complies | A dense white precipitate should form |
| 6 | Identification (Phosphate 1) | Complies | A neutral solution should yield yellow precipitate that soluble in 2N nitric acid and in 6N ammonium hydroxide |
| 7 | Identification (Phosphate 2) | Complies | A yellow precipitate should form of which color does not changes by boiling and which dissolves on addition of ammonia |
| 8 | Identification (Phosphate 3) | Complies | A yellow colour should develop |
| 9 | Appearance of solution | Passes | Clear and colorless solution |
| 10 | Water insoluble matter | 0.02% | NMT 0.15% |
| 11 | pH(5% aq soln) | 4.40 | 4.1 – 4.7 |
| 12 | Chloride (Cl) | Less than 0.005% | NMT 0.005% |
| 13 | Sulfate (SO4) | Less than 0.01% | NMT 0.01% |
| 14 | Heavy metals (as Pb) | 0.00002% | NMT 0.0005% |
| 15 | Aluminium, calcium and other elements detectable with ammonia | Passes | The sample solution should not become turbid when rendered slightly alkaline to litmus paper with 6N ammonium hydroxide. |
| 16 | Arsenic (As) | Less than 0.0001% | NMT 0.0001% |
| 17 | Iron (Fe) | Not detected | NMT 0.001% |
| 18 | Substances reducing KMnO4(O) | Passes | The color of the permanganate should not completely discharge |
| 19 | Loss on drying at 130°C | 22.5% | 22.0% - 24.0% |
| 20 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 21 | Total Yeast and mold count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 22 | Bacterial endotoxins | Less than 2.5IU/gm | NMT 2.5IU/gm |
| 23 | E.coli | Absent/gm | should be absent /gm |
| 24 | Pseudomonas aeruginosa | Absent/gm | should be absent /gm |
| 25 | Staphylococcus aureus | Absent/gm | should be absent /gm |
| 26 | Salmonella | Absent/10gm | should be absent /10gm |
| 27 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent /gm |
| 28 | Candida albicans | Absent/gm | should be absent /gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur AND 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.
