PDLLA MICROSPHERES
PDLLA material prepared into microspheres is a subcutaneous stimulatory filler with excellent performance. It possesses similar characteristics to PLLA microspheres, but with a faster degradation rate both in vivo and in vitro. Overall, PDLLA 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 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 | 29.09 |
| Intrinsic Viscosity [η] | dL/g | 0.64±0.05 | / | Refer to ASTM D 2857 in Cloroform 30℃ |
0.625 |
| Weight-average
Molecular Weight |
% | ≤0.5 | YY/T 0661-2017 | GPC | 0.45 |
| Moisture | % | ≤ 0.5 | YY/T 0661-2017 | Karl Fischer Coulometric Titration | 0.30 |
| Monomer Residue | ppm | ICH Limit Value | YY/T 0661-2017 | GC | Qualified |
| Methanol Solvent residue | ppm | ICH Limit Value | YY/T 0661-2017 | GC | Qualified |
| Heavy Metal Residue (Pb) | μg/g | ≤10 | YY/T 0661-2017 | Colorimetric Method of Chinese Pharmacopoeia |
Qualified |
| Sn Residue | μg/g | ≤100 | YY/T 0661-2017 | ICP | 61 |
| Specific Optical Rotation | ° | -10 ~ 10 | YY/T 0661-2017 | Polarimetric Test of Chinese Pharmacopoeia in Dichloromethane, 20 ℃ |
-1.7 |
*Produced in GMP workshop, each batch will provide the corresponding COA report.
| Model No. | Intrinsic Viscosity [η] (dL/g) | Particle size range |
| MP-PDLLA02A | 0.16-0.24 | 20-50 |
| MP-PDLLA04A | 0.32-0.48 | 20-50 |
| MP-PDLLA10A | 0.60-0.72 | 20-50 |
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