PLLA
PLLA are biocompatible, non-toxic and harmless to human body after being degraded in the body through metabolism.
Therefore, PLLA are widely used in the medical field, such as controlled-release and slow-release drug carrier; tissue engineering scaffolds, cardiovascular scaffolds, bone fixation, and bone repair materials (such as absorbable screws, absorbable bone plates), microcapsules for injection, microspheres, implants and animal organ support elastomers, etc.
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℃ |
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