PDLLA Porous Microspheres
PDLLA material prepared into porous microspheres is a subcutaneous stimulatory filler with excellent performance. It possesses similar characteristics to PLLA porous microspheres, but with a faster degradation rate both in vivo and in vitro. Overall, PDLLA porous microspheres, as a novel facial filler material, exhibit excellent biocompatibility, biodegradability, and the ability to stimulate collagen regeneration during degradation. At present, medical aesthetic filler products based on PDLLA porous microspheres have already been widely applied in clinical practice.
Product Index:
| Item | Unit | Standard | Reference standard | Method | Result |
|---|---|---|---|---|---|
| Appearance | / | / | / | Optical microscopy | Spherical particle |
| Median size (D50) | μm | 30±5 | / | Laser particle analyzer | 32.38 |
| Intrinsic viscosity [η] | dL/g | 1.0 ± 0.1 | / | 25 °C in Chloroform | 0.98 |
| Moisture | % | ≤ 0.5 | YY/T 0661-2017 | Karl Fischer coulometric titration | 0.49 |
| Monomer residue | % | ≤ 2.0 | YY/T 0661-2017 | GC | 0.42 |
| Solvent residue (Total) | ppm | ≤ 1000 | YY/T 0661-2017 | GC | Qualified |
| PVA residue | % | < 0.2 | / | UV | Qualified |
| Residual pore forming agent | ppm | / | / | IC | 3.81 |
| Heavy metal residue (Pb) | μg/g | ≤ 10 | YY/T 0661-2017 | Colorimetric method of Chinese Pharmacopoeia | Qualified |
| Sn Residue | μg/g | ≤ 150 | YY/T 0661-2017 | ICP | Qualified |
| Specific optical rotation | ° | -2 ~ 2 | YY/T 0661-2017 | Polarimetric test of Chinese Pharmacopoeia in dichloromethane, 20 °C | 0 |
*Produced in GMP workshop, each batch will provide the corresponding COA report.
Write your message here and send it to us
