| Sodium chloride USP/Ph.Eur/BP PARENTEX PLUS 25KG | |||
| I1570SK025 | 37239B116CV | ||
| USP/Ph.Eur/BP PARENTEX PLUS | 37239B1 | ||
| 7647-14-5 | 83500 | ||
| NaCl | March 2022 | ||
| 58.44 | February 2025 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | White crystalline powder. Has a saline taste. | Colorless, cubic crystals or white crystals or crystalline powder. Has a saline taste or almost white pearls. |
| 2 | Solubility | Passes | Freely soluble in water; and slightly more soluble in boiling water; soluble in glycerin; slightly soluble in alcohol. Practically insoluble in anhydrous ethanol |
| 3 | Identification(Sodium) | Complies | Dense white precipitate should form. |
| 4 | Identification (Chloride) | Complies | The precipitate dissolves easily with the possible exception of a few large particles, which dissolve more slowly |
| 5 | Appearance of Solution | Passes | Clear and colorless solution |
| 6 | Assay (Dried basis) | 99.8% | 99.0% -100.5% of NaCl |
| 7 | Arsenic (As) | Less than 1 ppm | NMT 1 ppm |
| 8 | Barium(Ba) | Passes | Any opalescence in the test solution should not more intense than that in the reference solution |
| 9 | Ferrocyanide[Fe(CN6)] | Passes | No blue color should develop in 10 min. |
| 10 | Iodide(I) | Passes | No blue color should observe in the mixture |
| 11 | Iron (Fe) | Less than 2ppm | NMT 2ppm |
| 12 | Bromide (Br) | Less than 100 ppm | NMT 100 ppm |
| 13 | Phosphate (PO4) | Less than 25ppm | NMT 25ppm |
| 14 | Magnesium and alkaline earth metals | Less than 100 ppm | NMT 100 ppm, calculated as Ca |
| 15 | Nitrites | 0.003 | Absorbance should not be more than 0.01 at 354 nm |
| 16 | Sulphate (SO4) | Less than 200ppm | NMT 200ppm |
| 17 | Acidity & alkalinity | 0.05ml of 0.01N sodium hydroxide | NMT 0.5ml of 0.01N hydrochloric acid or 0.01N sodium hydroxide should require to change the color of this solution. |
| 18 | Loss on drying,105°C | 0.2% | NMT 0.5% |
| 19 | Limit of potassium | Less than 500 ppm | NMT 500 ppm |
| 20 | Aluminum | Less than 0.2 ppm | NMT 0.2 ppm |
| 21 | Total aerobic microbial count | 05 CFU/gm | NMT 100 CFU/gm |
| 22 | Total Yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 23 | Escherichia coli | Absent/gm | Should be Absent/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 | Salmonella | Absent/10gm | Should be Absent/10gm |
| 28 | Bacterial endotoxin test | Less than 5.0 IU/gm | NMT 5.0 IU/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur 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.
