| Sodium acetate trihydrate USP/Ph.Eur/BP PARENTEX PLUS 25KG | |||
| I1500SK025 | 43068B105CX | ||
| USP/Ph.Eur/BP PARENTEX PLUS | 43068B1 | ||
| 6131-90-4 | 102012 | ||
| CH3COONa.3H2O | March 2024 | ||
| 136.08 | February 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | Colorless, transparent crystals. | Colorless, transparent crystals, or white, granular crystalline powder, or white flakes |
| 2 | Solubility | Complies | Very soluble in water, soluble in ethanol (96%) |
| 3 | Identification (For Acetates) | Complies | A blue precipitate should form or dark blue colour should devlope |
| 4 | Identification (Sodium) | Complies | A dence white precipitate should form |
| 5 | Identification (By Loss on drying) | 39.8% | 39.0% - 40.5% |
| 6 | Appearance of solution | Complies | Clear and colourless solution |
| 7 | pH | 8.1 | 7.5 - 9.0 |
| 8 | Reducing substances | Complies | A pink colour should persist for atleast 1h |
| 9 | Chlorides | Less than 200 ppm | NMT 200ppm |
| 10 | Sulphate (SO4) | Less than 50 ppm | NMT 50 ppm |
| 11 | Arsenic (As) | Less than 2 ppm | NMT 2ppm |
| 12 | Calcium(Ca)&Magnesium(Mg) | 24 ppm | NMT 50ppm |
| 13 | Calcium(Ca)& Magnesium(Mg) | Complies | No turbidity should produce within 5 min |
| 14 | Iron (Fe) | Less than 10 ppm | NMT 10ppm |
| 15 | Loss on drying,120°C | 39.3% | 38.0% - 41.0% |
| 16 | Loss on drying at 130°C | 39.8% | 39.0% - 40.5% |
| 17 | Assay (Dried substance) | 99.4% | 99.0% - 101.0% |
| 18 | Insoluble matter | 0.002% | NMT 0.05% |
| 19 | Potassium (K) | Complies | No precipitate should form |
| 20 | Aluminium (Al) | Less than 0.2 ppm | NMT 0.2 ppm |
| 21 | Total aerobic microbial count | Less than 100 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/10 gm | Should be absent/10 gm |
| 28 | Bacterial endotoxin test | Less than 0.5 EU/mg | NMT 0.5 EU/mg |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, 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.
