| Calcium Saccharate USP PARENTEX 1KG | |||
| P7483SR100 | 45611H225BY | ||
| USP PARENTEX | 45611H2 | ||
| 5793-89-5 | 110528 | ||
| C6H8CaO8.4H2O | February 2025 | ||
| 320.26 | January 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | White, odorless, crystaline powder. | White, odorless ,crystalline powder. | USP |
| 2 | Solubility | Complies | Soluble in dilute mineral acids; slightly soluble in boiling water; very slightly soluble in alcohol and in cold water, practically insoluble in ether and in chloroform. | USP |
| 3 | Identification A (Calcium) | Complies | A white precipitate, which should be insoluble in 6N acetic acid but soluble in hydrochloric acid | USP |
| 4 | Identification B (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard. | USP |
| 5 | Assay | 99.74% | 98.5% w/w - 102.0% w/w as C6H8CaO8. 4H2O | USP |
| 6 | chloride | Less than 0.07% | NMT 0.07% | USP |
| 7 | Sulfate | Less than 0.12% | NMT 0.12% | USP |
| 8 | Sucrose and reducing sugars | Complies | No red precipitate should form immediately. | USP |
| 9 | Specific rotation | +19.49° | +18.5° to + 22.5° | USP |
| 10 | Total aerobic microbial count | Less than 1000 CFU/gm | NMT 1000 CFU/gm | In-house |
| 11 | Total Yeast and mold count | Less than 100 CFU/gm | NMT 100 CFU/gm | In-house |
| 12 | Bacterial endotoxins | Less than 5.0 EU/gm | NMT 5.0 EU/gm | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP SPECIFICATION.
Actylis 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.
