| Calcium Saccharate CPH1-A 5KG | |||
| 13483SR500 | 316956117DT | ||
| Customised pharma grade1-A | 3169561 | ||
| 5793-89-5 | 63883 | ||
| C6H8CaO8.4H2O | April 2020 | ||
| 320.26 | March 2023 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | White, odorless,crystalline powder. | White, odorless ,crystalline powder. |
| 2 | Solubility | Passes | Soluble in dilute mineral acids; slightly soluble in boiling water; practically insoluble in alcohol, in cold water, in ether and in chloroform. |
| 3 | Identification A (Calcium) | Complies | A white precipitate, which is insoluble in 6N acetic acid but soluble in hydrochloric acid should form. |
| 4 | Identification B (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard. |
| 5 | Assay | 99.86% | 98.5% w/w - 102.0% w/w as C6H8CaO8. 4H2O |
| 6 | chloride | Less than 0.07% | NMT 0.07% |
| 7 | Sulfate | Less than 0.12% | NMT 0.12% |
| 8 | Sucrose and reducing sugars | Complies | No red precipitate should form immediately. |
| 9 | Specific rotation | +19.73° | +18.5° to + 22.5° |
| 10 | Total aerobic microbial count | Less than 10 CFU/g | 1000 CFU/g max |
| 11 | Total Yeast and mold count | Less than 10 CFU/g | 100 CFU/g max |
| 12 | Bacterial endotoxins | Complies | Less than 5 EU/g |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP 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.
