ITEMS | SPECIFICATION | RESULTS |
Appearance | White or almost white, amorphous or crystalline powder | Qualify |
Solubility | Freely soluble in water and in propylene glycol | Qualify |
Molar Substitution | 0.40-1.50 | 0.68 |
Clarity of solution | 50%(w/v) water solution is clear | clear |
Identification(IR) | same absorption bands as Hydroxypropyl Betadex RS | Qualify |
Loss on Drying | ≤10.0% | 3.2% |
Conductivity | 10%(w/v) water solution ≤200µS/cm | 35.5µS/cm |
Propylene glycol | ≤2.5% | 0.03% |
Sum of Other Impurities | ≤1% | Qualify |
Betadex | ≤1.5% | 0.4% |
Heavy Metal | ≤20μg/g | <10μg/g |
TAMC(cfu/g) | ≤1000cfu/g | 10cfu/g |
TYMC(cfu/g) | ≤100cfu/g | <10cfu/g |
Samonella/E. Coli | Absent | Absent |