| Customization: | Available |
|---|---|
| CAS No.: | 87-78-5 |
| Formula: | C6h14o6 |
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| Item | Standard | Result | |||||
| Appearance | White or almost white crystals or powder | White crystals | |||||
| Identification : Infrared absorption spectrophotometry | Conformity | Conformity | |||||
| Assay | 97.0% ~ 102.0% | 99.9% | |||||
| Related substances | Sorbitol≤2.0% | 0.1% | |||||
| Sum of Maltitol and Isomalt ≤2.0% |
Not detected | ||||||
| Unspecified impurities ≤0.10% |
Not detected | ||||||
| Total impurities ≤2.0% |
0.10% | ||||||
| Reducing sugars | ≤0.1% | <0.1% | |||||
| Nickel | ≤1µg/g | <1µg/g | |||||
| Melting point | 165 °C ~ 170 °C | 166 °C ~ 168°C | |||||
| Appearance of solution | Clear and colourless | Conformity | |||||
| Loss on drying | ≤0.5% | 0.1% | |||||
| Conductivity | ≤20µS/cm | 2.6µS/cm | |||||
| Microbial contamination | TAMC≤103 CFU/g | 10CFU/g | |||||
| TYMC≤102 CFU/g | 10CFU/g | ||||||
| Absence of Escherichia coli |
Negative/g | ||||||
| Bacterial endotoxins | ≤2.5 IU/g | <2.5 IU/g | |||||
| Residual solvents | The raw materials, manufacturing process and product do not contain any of the solvents listed in Residual Solvents (USP<467>) |
||||||
| Conclusion: | Conformity | ||||||
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