2‑Hydroxypropyl‑β‑cyclodextrin (HP‑β‑CD / HPBCD) CAS No.: 128446-35-5
| ITEMS | CRITERIA |
| Batch No. | 20251002 |
| Packing | 25kg/Drum |
| Manufacturing Date | 2025.10.15 |
| Sampling Date | 2025.10.24 |
| Report Date | 2025.11.01 |
| Sampling Location | Clean Workshop |
| Expiry Date | 2028.10.14 |
| Test Standard | EP11.0 |
| Description | White or almost white, amorphous or crystalline powder |
| IR Spectrum | Conforms to reference standard |
| Identification | Conforms to reference standard |
| Clarity of Solution | Clear and colorless |
| Solubility | Freely soluble in water and in propylene glycol |
| Molar Substitution (MS) | 0.40 ~ 1.50 |
| Loss on Drying (%) | ≤10.0 |
| Degree of Substitution (DS=7×MS) | 2.80 ~ 10.50 |
| Impurity A (HPLC) (%) | ≤1.5 |
| Sum of impurities other than A (HPLC) (%) | ≤1.0 |
| Impurity B (GC) (%) | ≤2.5 |
| Conductivity (μS/cm) | ≤200 |
| Total aerobic microbial count (cfu/g) | ≤10 |
| Total combined molds & yeasts count (cfu/g) | ≤10 |
| Escherichia coli (cfu/g) | Absent |
| Salmonella | Absent |
| Conclusion | Complies with EP11.0, Compliant for pharmaceutical grade use |
