Sodium Chloride IP/BP
Product Brief: Pharmaceutical grade sodium chloride is characterized on the basis of applications that include injections, hemodialysis, peritoneal dialysis, & hemofiltration solutions, oral rehydration salts (ORS), channeling agents/ osmotic agent, mechanical cleansing solutions, and others (dietary formulations and infant formulations).
Product Specifications:
| Sr.No | Test | Specification (IP) | Specification (BP) |
| 1. | Description | White orcolourless crystals or a white crystalline powder | White orcolourless crystals or a white crystalline powder |
| 2. | Identification | A. It gives the reactions of chlorides B. Gives the reactions of salts | A. It gives the reactions of chlorides B. Gives the reactions of salts |
| 3. | solubility | Freely soluble in water,slightlymore soluble | Freely soluble in water,slightlymore soluble |
| 4. | Appearance of solution | Solution A is clear and colourless | Solution A is clear and colourless |
| 5. | Acidityoralkalinity | Not mare than 0.5 ml of 0.01M hydrochloric acid or 0.01Msodium hydroxide is required to change the colour of the solution | Not mare than 0.5 ml of 0.01M hydrochloric acid or 0.01Msodium hydroxide is required to change the colour of the solution |
| 6. | Arsenic | The resulting solution complies with the limit test for arsenic(NMT1 ppm) | The resulting solution complies with the limit test for arsenic(NMT1 ppm) |
| 7. | Barium | No turbidity is produced within 2 hours | No turbidity is produced within 2 hours |
| 8. | Bromide | NMT 100 ppm | NMT 100 ppm |
| 9. | Calcium and Magnesium | NMT 50 ppm | NMT 50 ppm |
| 10. | Fcrrocyonidc | No blue color is produced within 10 minutes | No blue color is produced within 10 minutes. |
| 11. | Heavy metals | The solution complies with the limit test for heavy metals,(5ppm) | The solution complies with the limit test for heavy metals,(5ppm). |
| 12. | iodide | The substance shows no blue colour after 5 minutes | The substance shows no blue colour after 5 minutes. |
| 13. | Iron | NMT 20 ppm | NMT 20 ppm |
| 14. | Sulphate | NMT 300 ppm | NMT 300 ppm |
| 15. | Loss on drying | NMT 1.0% w/w | NMT 1.0% w/w |
| 16. | Assay | 99.0 % to 100.5 % ODB | 99.0 % to 100.5 % ODB |
| MICROBIAL LIMITS | |||
| 1. | Total bacterial count | ---- | NMT 1000 CFU/GM |
| 2 | Totalyeast and Mould | ---- | NMT 100 CFU/GM |