| CAS No.: | 6099-90-7 |
|---|---|
| Formula: | C6h10o5 |
| EINECS: | 612-061-6 |
| Shape: | Powdery |
| Grade Standard: | Medicine Grade |
| Color: | White |
| Samples: |
|---|
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| Analysis Item | Specification | Results |
| Appearance | White or almost white powder | White powder |
| Solubility | Sparingly soluble in water, freely soluble in ethanol(96 %), practically insoluble in methylene chloride | Conform |
| Identification | ||
| (a) IR | (a) IR confirms to the CRS(2.2.24) | (a) Conform |
| (b) TLC | (b) The principal spot in the chromatogram obtained with the test solution is similar in position and size to the reference solution | (b) Conform |
| (c) LOD | (c) Between 20.0% to 23.0% | (c) 21.9% |
| Appearance of Solution | Clear and not more intensely coloured than reference solution BY5 | Conform |
| PH of Solution | Between 4.0 to 6.0 | 5.8 |
| Related Substances | Impurity A ≤ 0.15% | Not detected |
| Impurity D ≤ 0.15% | Not detected | |
| Impurity E ≤ 0.15% | Not detected | |
| Impurity K ≤ 0.15% | Not detected | |
| Impurity L ≤ 0.15% | Not detected | |
| Impurity I ≤0.15% | Not detected | |
| Unspecified impurities ≤ 0.10% | Not detected | |
| Total impurities ≤ 0.30% | Not detected | |
| Chlorides | ≤ 200ppm | Conform |
| Sulfates | ≤500ppm | Conform |
| Heavy metals | ≤20ppm | Conform |
| Sulfated ash | ≤ 0.1% | 0.04% |
| Loss on dry | Between 20.0% to 23.0% | 21.90% |
| Residual solvent | 1,2,4-trimethyl benzene ≤ 20ppm | Not detected |
| Assay(on the dried basis) | 99.0% ~ 101.0% | 100.20% |
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