Description
Crospovidone exhibits outstanding compatibility with a wide variety of APIs and other excipients. It does not interact chemically with drugs, ensuring the stability of pharmaceutical products. Its inert nature, combined with excellent flowability and compressibility, makes it easy to incorporate into different manufacturing processes, whether for high-speed tablet production or complex capsule filling operations.
Our Crospovidone undergoes rigorous quality control and testing to meet the strictest pharmacopoeial standards. Advanced purification techniques guarantee its high purity, free from harmful contaminants, heavy metals, and microbial impurities. With consistent batch-to-batch quality and reliable performance, it is an essential excipient for pharmaceutical manufacturers aiming to produce high-quality, fast-acting medications that meet the diverse needs of patients.
Specification
| Item | USP | BP/EP | CP |
| Identification | Conforms | ||
| pH | —— | 5.0-8.0 | |
| Loss on drying (%) | ≤5.0 | ||
| Residue on Ignition/ Sulfated ash (%) | ≤0.1 | ||
| Water-soluble substances (%) | ≤1.5 | ≤1.0 | |
| Vinyl pyrrolidinone (Impurity A) | ≤10ppm | ≤0.001% | |
| Nitrogen content (%) | 11.0-12.8 | ||
| Peroxides(H2O2) | ≤400ppm | ≤0.04% | |
| Arsenic(%) | —— |
| ≤0.0002 |
| Hydration capacity | —— | 3-9 | —— |
| Particle-size distribution | —— | Conforms | —— |
| Powder flow | —— | Conforms | —— |
| Settling volume(ml) | —— | ≥60 | —— |
| Heavy metal(%) | —— | ≤0.001 | |
| Microbial limits | Conforms | ||
Packaging
- PACKING: 20kg/drum
- STORAGE AND TRANSPORT: IN DRY AND COOL NORMAL TEMPERATURE
- G.W. 22.5kg