Appearance: White or almost white crystals or powder
Standards & Certifications:
Kosher,Halal,Meets USP/BP/EP/FCC Standards
Package: 25 KG/BAG
I. Specification
Item | Specification Test | Result | |
Appearance | White or almost white crystals or powder | Conforms | |
Solubility | Freely soluble in water,practically insoluble in ethanol (96 per cent). | Conforms | |
Identification | Specific Optical Rotation | +23°~ +25° | +24.2° |
Melting Point | 165.0ºC~170.0ºC | 166.3ºC~167.4ºC | |
Infrared Absorption | Conforms | Conforms | |
Appearance of solution | Clear and colorless | conforms | |
Conductivity | ≤20µS/cm | 2.0µS/cm | |
Reducing Sugars | ≤0.1% | <0.1% | |
Related Substances (≤0.05% Disregard limit ≤0.05%) | A (Sorbitol) | ≤2.0% | 0.49% |
B+C(Maltitol+Isomalt) | ≤2.0% | 0.00% | |
Unspecified | ≤0.1% | 0.03% | |
Total | ≤2.0% | 0.56% | |
Nickel | ≤1ppm | <1ppm | |
Heavy Metals | ≤5ppm | <5ppm | |
Loss on Drying | ≤0.5% | 0.14% | |
Microbiological | TAMC | ≤103cfu/g | 10cfu/g |
TYMC | ≤102cfu/g | <10cfu/g | |
E. Coli | Negative | Negative | |
Salmonella | Negative | Negative | |
Bacterial Endotoxins | <2.5IU/g | <0.625IU/g | |
Assay | 97.0%~102% | 99.90% | |
Pyrogen | Free | ||
Conclusion | Comply with BP /USP/EP Requirements. |
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