| Calcium Saccharate CPH1-A 100GM | |||
| 13483SG100 | 299626125IS | ||
| Customied pharma grade1-A | 2996261 | ||
| 5793-89-5 | 58481 | ||
| C6H8CaO8.4H2O | September 2019 | ||
| 320.26 | August 2022 | ||
| 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; very slightly soluble in alcohol, and in cold water; practically insoluble 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 | 99.93% | 98.5% w/w - 102.0% w/w |
| 6 | Chloride (Cl) | Less than 0.07% | NMT 0.07% |
| 7 | Sulfate | Less than 0.12% | NMT 0.12% |
| 8 | Sucrose and reducing sugars | Passes | No red precipitate should form immediately |
| 9 | Optical Rotation | +21.03° | +18.5° to + 22.5° |
| 10 | Total aerobic microbial count | Absent | 1000 CFU/g max |
| 11 | Total Yeast and mold count | Absent | 100 CFU/g max |
| 12 | Bacterial endotoxins | Complies | Less than 5 EU/g |
| 13 | Methanol as residual solvent | Not detected | NMT 3000 ppm |
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.
