PDLLA
PDLLA are biocompatible, often used as drug release carriers – encapsulating medicine in polymer matrix to form microspheres or particles. It is approved by FDA as excipients and internal fixation devices for injectable microcapsules, microspheres and implants such as corrosion inhibitors; porous foam scaffolds for tissue engineering cell culture; bone fixation or tissue repair materials for tissue engineering; surgical sutures; implant sheets and clamps; artificial skin, artificial blood vessels; ophthalmic implant materials for retina; Implant sheets and clamps; artificial skin, artificial blood vessels; ophthalmic implant material retina, etc.
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℃ |
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