| L(+)Ascorbic acid Excipient grade 500GM | |||
| 80220SG500 | 865181724EU | ||
| Excipient Grade | 8651817 | ||
| 50-81-7 | 77315 | ||
| C6H8O6 | May 2021 | ||
| 176.12 | April 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Slightly yellow crystalline powder On exposure to light it gradually darkens. | White or almost white or slightly yellow crystals or crystalline powder On exposure to light it gradually darkens. |
| 2 | Solubility | Passes | Freely soluble in water; sparingly soluble in ethanol (96%) and in alcohol; insoluble in chloroform, in ether & in benzene. |
| 3 | Appearance of solution | Complies | Solution should be clear & not more intensely colored than reference solution BY7. |
| 4 | Identification (By UV spectrophotometry) | 569 | Absorption maximum at 243 nm & specific absorption at absorption maximum : 545 to 585 |
| 5 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard. |
| 6 | Identification (By pH) | 2.3 | pH of solution : 2.1 to 2.6 |
| 7 | Identification (By chemical test 1) | Complies | A grey precipitate should form |
| 8 | Identification (By chemical test 2) | Complies | A 20 mg/mL solution reduces alkaline cupric tartrate solution slowly at room temperature but more readily upon heating |
| 9 | Specific optical rotation | +20.7° | +20.5° to +21.5° |
| 10 | Melting point | 190°C | About 190°C with decomposition |
| 11 | Impurity E (Oxalic acid) | Less than 0.2% | 0.2% max. |
| 12 | Related substances Impurity C (L-sorbosonic acid) | Not detected | 0.15% max. |
| 13 | Related substances Impurity D (Methyl L-sorbosonate) | Not detected | 0.15% max. |
| 14 | Related substances: unspecified impurity | 0.01% | 0.10% max. |
| 15 | Related substances: Sum of impurities other than C and D | 0.02% | 0.2% max. |
| 16 | Copper (Cu) | Less than 5ppm | 5ppm max. |
| 17 | Iron (Fe) | Less than 2ppm | 2ppm max. |
| 18 | Sulphated ash / Residue on ignition | 0.06% | 0.1% max. |
| 19 | Assay | 99.6% | 99.0% to 100.5% |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur 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.
