CERTIFICATE OF QUALITY
Product: | Dextran 40 |
Grade | BP 2004 / USP 28 /EP 5 Grade |
Lot: | OF3004A |
Code: | 124040 |
CAS-No: | [9004-54-0] |
Mol. Formula: | (C6H10O5)n |
Packing: | 25 Kg / Drum |
Item Specifications Results
Identification | Positive | Positive |
Specific Rotation | 195.0~201.0° | 197.51° |
Infrared absorption spectrogram | Comparing with the spectrum obtained from dextran CRS | Complies |
Solubility | Very soluble in water, very slightly soluble in alcohol | Complies |
Appearance of solution | Clear and colorless | Complies |
Acidity or alkalinity | Reaction with phenolphatein, NaOH and HCl | Complies |
Nitrogenous | ≤110ppm | <50ppm |
Residual solvents | Ethanol : ≤0.5% | 0.05% |
| Methanol : ≤0.05% | 0.05% |
| Other residual solvent : ≤0.5% | Negative |
Loss on drying | ≤7.0% | 5.34% |
Residue on ignition | ≤0.3% | 0.07% |
Heavy metals | ≤10ppm | <5ppm |
Bacterial endotoxins | <10 IU/g | <5 IU/g |
Microbial contamination | Total viable aerobic : ≤100 CFU/g | <10 CFU/g |
| No colibacillus | Negative |
Mol. Weight | 35000~45000 | 39390 |
Viscosity | 16.0~16.8 | 16.0~16.8 |
Appearance | White powder | White powder |
