| Customization: | Available |
|---|---|
| Type: | Calcium Organic Salt |
| Appearance: | Powder |
|
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| Item | Limit |
| Characteristics | Appearance: This product is a white granular powder, odorless and tasteless |
| Optical rotation:+6° to +11° | |
| Solubility:This product is soluble in boiling water, slowly dissolves in water, and is insoluble in anhydrous ethanol, chloroform, or ether | |
| Identification | A.Positive reaction |
| B.According to the thin-layer chromatography experiment, the position and color of the main spots on the test solution should be the same as those on the control solution | |
| C.The infrared absorption spectrum of this product should be consistent with the reference spectrum | |
| D.The aqueous solution of this product should exhibit a calcium salt identification reaction | |
| PH | 6.4-8.0 |
| Appearance of solution | Conform |
| Chloride | Not more than 0.005% |
| Sulfate | Not more than 0.005% |
| Phosphate | Not more than 0.01% |
| Related substance | Tartaric acid:not more than 0.05% |
| Formic acid: not more than 0.05% | |
| Acetic acid:not more than0.05% | |
| 5-hydroxymethylfurfural:not more than0.01% | |
| Other individual impurities: Not more than0.05% |
|
| Total impurities:not more than0.5% | |
| Oxalate | Not more than 0.01% |
| Glucuronic acid | Not more than 0.05% |
| Organic impurities and boric acid | Meets the requirements. |
| Sucrose or reducing sugar | No red sediment shall be generated within 2 minutes |
| Magnesium and Alkali metals | Not more than 2mg |
| Iron | Not more than 0.0005% |
| Loss on drying | Not more than 1.0% |
| Heavy metals | Not more than 0.0001% |
| Arsenic | Not more than 0.0002% |
| Gluconate radical | 83% - 92% |
| Bacterial endotoxin | The amount of bacterial endotoxin per 1mg should be less than 0.05EU |
| Microbial limit | The total number of aerobic bacteria :not more than 200cfu/g |
| The total number of mold and yeast :not more than 20cfu/g | |
| Escherichia coli should not be detected | |
| Assay | 99.0%-101.0% |
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