PDLLA
As an FDA-approved excipient, this medical grade PDLLA polymer is harmless to the human body and offers excellent degradation properties.
Poly(DL-lactic acid) is highly effective for internal fixation devices, injectable microcapsules, and porous foam scaffolds for tissue engineering. Its applications also extend to bone fixation, surgical sutures, implant sheets, artificial skin, and ophthalmic implants, making it a versatile choice for advanced biomedical manufacturing.
Product Index:
| Item | Unit | Standard Values | Reference Standard | Method | Result |
| Appearance | / | White to off white granules | / | Visual Inspection | conforms |
| Intrinsic Viscosity [η] | dL/g | / | YY/T 0661-2017 | Refer to ASTM D 2857 30℃ in Chloroform |
0.73 |
| Moisture | % | ≤0.5 | YY/T 0661-2017 | KFT | 0.08 |
| Monomer residue（ DL-LA） |
% | ≤2 | YY/T 0661-2017 | GC | 1.02 |
| Solvent residue | ppm | <1000 | YY/T 0661-2017 | GC | conforms |
| Heavy metal residue (Pb) |
μg/g | ≤10 | YY/T 0661-2017 | 0841 Heavy metal detection method in Chinese Pharmaco poeia |
conforms |
| Sn Residue | μg/g | ≤150 | YY/T 0661-2017 | ICP | conforms |
| Specific Rotation | ° | -1 ~ 1 | YY/T 0661-2017 | Chinese Pharmacopoeia Optical Rotation Detection Method, in dichloromethane at 20 °C |
0.41 |
*Produced in GMP workshop, each batch will provide the corresponding COA report.
| Model No. | Intrinsic Viscosity [η] (dL/g) | Test Conditions |
| PDLLA02 | 0.16-0.24 | TCM，25℃ |
| PDLLA04 | 0.32-0.48 | TCM，25℃ |
| PDLLA10 | 0.60-0.72 | TCM，25℃ |
