| Sodium tartrate CDMF PARENTEX PLUS 500GM | |||
| I3697SG500 | 40649B426DW | ||
| CDMF PARENTEX PLUS | 40649B4 | ||
| 6106-24-7 | 94737 | ||
| C4H4O6Na2.2H2O | April 2023 | ||
| 230.08 | March 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Transparent, colorless, odourless crystals. | Transparent, colorless, odourless crystals. |
| 2 | Solubility | Complies | Freely soluble in water; insoluble in alcohol. |
| 3 | Identification A (Sodium) | Complies | A dense precipitate should form. |
| 4 | Identification B (Tartrate) | Complies | Reddish pink color should produce within 15 min. |
| 5 | Assay (on dried basis) | 99.8% | 99.0%-100.5% |
| 6 | pH (10% aq soln) | 8.1 | 7 - 9 |
| 7 | Loss on drying, 150°C for 3 Hr. | 15.4% | 14.0% - 17.0% w/w |
| 8 | Specific optical rotation | +30.5° | + 29.5° to + 31.5° |
| 9 | Clarity and colour of solution | Complies | Any colour produced is not more intense than that of reference solution Y2. |
| 10 | chloride | Less than 0.002% | NMT 0.002% |
| 11 | Sulfate | Less than 0.005% | NMT 0.005% |
| 12 | Iron | Less than 0.001% | NMT 0.001% |
| 13 | Heavy metals | Less than 0.002% | NMT 0.002% |
| 14 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 15 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 16 | Staphylococcus aureus | Absent/gm | should be absent/gm |
| 17 | Pseudomonas aeruginosa | Absent/gm | should be absent/gm |
| 18 | Bacterial endotoxins | Less than 2.5 EU/gm | NMT 2.5 EU/gm (For injectable grade only) |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, CP 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.
