PLLA
PLLA polymer is biocompatible, non-toxic, and harmless to the human body, as it naturally degrades through normal metabolism.
Therefore, this medical grade PLA polymer is widely used in the medical field for applications such as controlled-release and slow-release drug carriers, tissue engineering scaffolds, cardiovascular scaffolds, bone fixation and repair materials (e.g., absorbable screws and plates), microcapsules for injection, microspheres, implants, and animal organ support elastomers.
Product Index:
| Item | Unit | Standard Values | Reference Standard | Method | Result |
| Appearance | / | / | / | Visual Inspection | White Solid |
| Intrinsic Viscosity [η] | dL/g | 1.5-2.0 | / | Refer to ASTM D 2857 in Cloroform 30℃ |
1.65 |
| Moisture | % | ≤0.5 | YY/T 0661-2017 | Karl Fischer Coulometric Titration |
0.29 |
| Monomer Residue | % | ≤0.5 | YY/T 0661-2017 | GC | 0.06 |
| Solvent Residue (Dichloromethane) |
ppm | ICH Limit Value | YY/T 0661-2017 | GC | Qualified |
| Solvent Residue (Total) |
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 | ≤150 | YY/T 0661-2017 | ICP | Qualified |
| Specific Rotation | ° | -155 ~ -160 | YY/T 0661-2017 | Polarimetric Test of Chinese Pharmacopoeia In Dichloromethane, 20 °C |
-157 |
*Produced in GMP workshop, each batch will provide the corresponding COA report.
| Model No. | Intrinsic Viscosity [η] (dL/g) | Test Conditions |
| PLLA10 | 0.9-1.2 | TCM，25℃ |
| PLLA18 | 1.5-2.0 | TCM，25℃ |
| PLLA24 | 2.0-2.7 | TCM，25℃ |
| PLLA32 | 2.7-3.6 | TCM，25℃ |
| PLLA38 | 3.2-4.3 | TCM，25℃ |
| PLLA65 | 5.6-7.5 | TCM，25℃ |
