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Puromill™ 研磨介质
PuroMill™药用级先进工艺的研磨介质可帮助您提高研发成品质量。它是一种低密度聚合物研磨介质，能够制备小于100 nm的纳米颗粒，这些纳米颗粒不会因可萃取、可浸出和磨损而受到污染。使用传统或新型铣削设备进行高剪切铣削。
PuroMill™通过先进的纳米颗粒研磨技术实现溶解度增强。
- 提高药物化合物的生物利用度
- 高纯度聚合物研磨介质
- 在cGMP认证、FDA检查的工厂生产
- 药物/生物制药制剂理想的研磨材料
- 生产小于100 nm的药物纳米颗粒，以增强溶解性差的药物的吸收
- 实现高效生物细胞破坏，无需研磨相关污染
- 尺寸为50–1000µm，用于优化药物制剂的研磨性能
- 在FDA注册的药品主文件（DMF文件）
TYPICAL PHYSICAL & CHEMICAL CHARACTERISTICS:
| Polymer Structure | Gel polystyrene crosslinked with divinylbenzene | |
| Appearance | Non-aggregated spherical beads, white to off-white in color | |
| < 150 µm (max.) | 0.01 % | |
| 250 – 350 µm (min.) | 95 % | |
| Particle Size Range | 250 – 350 µm | |
| Loss on drying (max.) | 0.5 % | |
| Residual styrene (max.) | 50 ppm | |
| Residual divinylbenzene (max.) | 50 ppm | |
| Residual ethylvinylbenzene (max.) | 50 ppm | |
| Residual solvent – methanol (max.) | 50 ppm | |
| Impurities Heavy Metals (max.) | 10 ppm | |
| Total Aerobes | < 10 cfu/g | |
| Total Moulds | < 10 cfu/g | |
| Total Yeasts | < 10 cfu/g | |
| Escherichia coli | Negative/ 10 g g | |
| Salmonella species | Negative/ 10 g g | |
| Pseudomonas aeruginosa | Negative/ 10 g g | |
| Staphylococcus aureus | Negative/ 10 g g | |
| Bacterial endotoxin test (max.) | 0.5 EU/g | |
| Identification (FTIR) | Conform to Standard | |
TYPICAL PHYSICAL & CHEMICAL CHARACTERISTICS:
| Polymer Structure | Gel polystyrene crosslinked with divinylbenzene | |
| Appearance | Non-aggregated spherical beads, white to off-white in color | |
| < 150 µm (max.) | 0.02 % | |
| 250 – 350 µm (min.) | 95 % | |
| Particle Size Range | 450 – 550 µm | |
| Specific Gravity | 1.06 | |
| Bulk Density (approx.) | 610 g/l | |
| Loss on drying (max.) | 0.5 % | |
| Residual styrene (max.) | 50 ppm | |
| Residual divinylbenzene (max.) | 50 ppm | |
| Residual ethylvinylbenzene (max.) | 50 ppm | |
| Residual solvent – methanol (max.) | 50 ppm | |
| Impurities Heavy Metals (max.) | 10 ppm | |
| Total Aerobes | < 10 cfu/g | |
| Total Moulds | < 10 cfu/g | |
| Total Yeasts | < 10 cfu/g | |
| Escherichia coli | Negative/ 10 g g | |
| Salmonella species | Negative/ 10 g g | |
| Pseudomonas aeruginosa | Negative/ 10 g g | |
| Staphylococcus aureus | Negative/ 10 g g | |
| Bacterial endotoxin test (max.) | 0.5 EU/g | |
| Identification (FTIR) | Conform to Standard | |
TYPICAL PHYSICAL & CHEMICAL CHARACTERISTICS:
| Polymer Structure | Gel polystyrene crosslinked with divinylbenzene | |
| Appearance | Non-aggregated spherical beads, white to off-white in color | |
| < 150 µm (max.) | 0.01 % | |
| 250 – 350 µm (min.) | 95 % | |
| Particle Size Range | 250 – 350 µm | |
| Loss on drying (max.) | 0.5 % | |
| Residual styrene (max.) | 50 ppm | |
| Residual divinylbenzene (max.) | 50 ppm | |
| Residual ethylvinylbenzene (max.) | 50 ppm | |
| Residual solvent – methanol (max.) | 100 ppm | |
| Impurities Heavy Metals (max.) | 10 ppm | |
| Total Aerobes | < 10 cfu/g | |
| Total Moulds | < 10 cfu/g | |
| Total Yeasts | < 10 cfu/g | |
| Escherichia coli | Negative/ 10 g g | |
| Salmonella species | Negative/ 10 g g | |
| Pseudomonas aeruginosa | Negative/ 10 g g | |
| Staphylococcus aureus | Negative/ 10 g g | |
| Bacterial endotoxin test (max.) | 0.5 EU/g | |
| Identification (FTIR) | Conform to Standard | |
PRINCIPAL APPLICATIONS
| System
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ADVANTAGES
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