| Sodium chloride CDMF PARENTEX PLUS 500GM | |||
| I3570SG500 | 37239B416CV | ||
| CDMF PARENTEX PLUS | 37239B4 | ||
| 7647-14-5 | 83499 | ||
| NaCl | March 2022 | ||
| 58.44 | February 2025 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | White crystalline powder. | Colorless, cubic crystals or white crystals or crystalline powder. |
| 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 | A white curdled precipitate should form which is insoluble in nitric acid but soluble in slight excess of 10N ammonia hydroxide |
| 5 | Appearance of Solution/ Clarity of solution | Passes | Clear and colorless solution |
| 6 | Assay (Dried basis) | 99.8% | 99.0% -100.5% of NaCl |
| 7 | Arsenic (As) | Less than 0.4 ppm | NMT 0.4 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 or no particle shows any trace of blue color within 5 min. |
| 11 | Iron (Fe) | Less than 2ppm | NMT 2ppm |
| 12 | Bromide (Br) | Less than 100ppm | NMT 100ppm |
| 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 | Nitrite(NO2) | 0.003 | Absorbance should not be more than 0.01 at 354 nm |
| 16 | Sulphate (SO4) | Less than 0.002% | NMT 0.002% |
| 17 | Acidity or Alkalinity | 0.05mL sodium hydroxide (0.02 mol/L) | NMT 0.10mL sodium hydroxide (0.02 mol/L) should require to change the color of solution from yellow to blue or NMT 0.20 mL of hydrochloric acid (0.02 mol/L) should require to change the color of solution from blue or green to yellow |
| 18 | Loss on drying,105°C | 0.2% | NMT 0.5% |
| 19 | Limit of potassium | Less than 0.02% | NMT 0.02% |
| 20 | calcium | Passes | No opalescence should produce within 5 min. |
| 21 | Magnesium (Mg) | Less than 0.001% | NMT 0.001% |
| 22 | Aluminum | Less than 0.2 ppm | NMT 0.2 ppm |
| 23 | Total aerobic microbial count | 05 CFU/gm | NMT 100 CFU/gm |
| 24 | Total Yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 25 | Escherichia coli | Absent/gm | should be absent/gm |
| 26 | Pseud. aeruginosa | Absent/gm | should be absent/gm |
| 27 | Staphylococcus aureus | Absent/gm | should be absent/gm |
| 28 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm |
| 29 | Salmonella | Absent/10 gm | should be absent/10 gm |
| 30 | 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 AND Ch.P 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.
