1 | Appearance | White crystalline powder, becoming discoloured on exposure to air and moisture. | White or almost white, crstalline powder or colorless crystal, becoming discoloured on exposure to air and moisture. |
2 | Solubility | Complies | Freely soluble in water, sparingly soluble in ethanol (96%) |
3 | Identification A (By UV spectrophotometry) | Complies | Absorption maximum at : 243 nm, Specific absorbance at the absorption maximum : 545 to 585. |
4 | Identification B (By IR) | Complies | IR spectra of the sample should be concomittant with IR spectra of the standard. |
5 | Identification C (By pH) | 2.2 | 2.1 - 2.6 |
6 | Appearance of solution | Complies | Solution should be clear and not more intensely colored than reference solution BY7. |
7 | Impurity E (Oxalic acid) | Complies | NMT 0.2% |
8 | Related substances Impurity C (L-sorbosonic acid) | Not detected | NMT 0.15% |
9 | Related substances Impurity D (Methyl L-sorbosonate) | Not detected | NMT 0.15% |
10 | Related substance (Unspecified impurities) | Not detected | NMT 0.10% |
11 | Related substances: Sum of impurities other than C and D | Not detected | NMT 0.2% |
12 | Copper (Cu) | Less than 5 ppm | NMT 5 ppm |
13 | Iron | Less than 2 ppm | NMT 2 ppm |
14 | Sulfated ash | 0.05% | NMT 0.1% |
15 | Assay | 99.3% | 99.0% - 100.5% |