CAS number： 97-67-6
Molecular formula： HO2CCH2CH(OH)CO2H
molecular weight： 134.09
Chemical structure：
| Specification | ChP20165 | |||
| Items | Specifications | Results | ||
| Appearance | White crystal or white crystalline powder, odorless, tasteless. | white crystalline powder, odorless,tasteless. | ||
| Solubility | It is very soluble in water, freely soluble in ethanol or acetone. | Complies | ||
| Specific rotation | -1.6°～-2.6° | -1.9° | ||
| Identification | Chemical identification: Positive reaction | Complies | ||
| IR: Complies | Complies | |||
| pH | 1.5～2.0 | 1.8 | ||
| Clarity and color of solution | Solution should be clear and colorless. | Complies | ||
| Light transmittance | 98% | 100% | ||
| Insoluble matter in water | ≤0.1% | 0.019% | ||
| Related substance | Maleic acid≤0.01% | Not detected | ||
| Fumaric acid≤0.10% | 0.0023% | |||
| Other maximum unknown impurity≤0.05% | 0.0059% | |||
| Other total impurities<0.20% | 0.0068% | |||
| Residual solvent | Tetrahydrofuran≤0.072% | Not detected | ||
| Ethyl acetate≤0.5% | 0.0600% | |||
| Dichloromethane≤0.06% | 0.0100% | |||
| Water | ≤2.0% | 0.2500% | ||
| Calcium salt | ≤0.02% | Complies | ||
| Readily oxidizable substance | Should conform | Complies | ||
| Chloride | ≤0.005% | Complies | ||
| Sulfate | ≤0.01% | Complies | ||
| Arsenic salt | ≤0.0001% | Complies | ||
| Residue on ignition | ≤0.1% | 0.0080% | ||
| Arsenic salt | ≤0.0003% | Complies | ||
| Heavy metals | ≤10ppm | Complies | ||
| Bacterial endotoxin | ≤0.043EU/mg | Complies | ||
| Microbial limit | Total aerobic microbial count(TAMC):≤1000cfu/g | Complies | ||
| Total yeast and mould count(TYMC): ≤100cfu/g | ||||
| Escherichia coli: Should not exist | ||||
| Assay | ≥99.0% | 100.70% | ||
| Conclusion | Complies with the requirement of specification protocol of L-malic acid | Conclusion | ||
| Containers and storage | Containers—Tight containers Storage—Light-resistant and cool place | |||
