| Calcium Saccharate CDMF PARENTEX 5KG | |||
| P3483SR500 | 45044C309LX | ||
| CDMF PARENTEX | 45044C3 | ||
| 5793-89-5 | 108358 | ||
| C6H8CaO8.4H2O | December 2024 | ||
| 320.26 | November 2027 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | White, odorless, tasteless crystalline powder. | White, odorless ,tasteless crystalline powder. | USP |
| 2 | Solubility | Complies | Freely soluble in dilute hydrochloric acid or dilute nitric acid; slightly soluble in boiling water; very slightly soluble in cold water; insoluble in ethanol, ether, or chloroform. | CP |
| 3 | Identification A (Calcium) | Complies | A white precipitate, which is insoluble in 6N acetic acid but soluble in hydrochloric acid should form. | 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 | 99.7% | 99.0% w/w - 101.0% w/w | USP/CP |
| 6 | Chloride (Cl) | 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 | Optical Rotation | +20.6° | +17.5° to + 21.5° | CP |
| 10 | Heavy metals | Less than 10ppm | NMT 10ppm | CP |
| 11 | Total aerobic microbial count | Less than 1000 CFU/gm | NMT 1000 CFU/gm | In-house |
| 12 | Total Yeast and mold count | Less than 100 CFU/gm | NMT 100 CFU/gm | In-house |
| 13 | E.coli | Absent/gm | should be absent/gm | USP/CP |
| 14 | Bacterial endotoxins | Less than 5 EU/gm | NMT 5 EU/gm (For in-house control only, not for release & shelf life) | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, CP 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.
