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:
Test Items | Detection Method | Testing requirements |
Appearance | Visual Inspection | White solid |
Intrinsic Viscosity | Ubbelohde Viscometer Method | 0.18-4dl/g |
Molecular Weight Distribution | GPC | ≤2.0 |
Specific Optical Rotation | Polarimeter Chloroform 0.01g/mL | -5°~5° |
Water Content | Karl Fischer moisture Analyzer | ≤0.5% |
Ash Content | Gb/T9345.1-2008 | ≤0.5% |
Monomer Residue | GC | ≤2% |
Solvent Residue | HS-GC-MS | ≤1000ppm |
Tin Residue | AAS | ≤150ppm |
Heavy Metals(pb) | Heavy Metal Inspection Method | ≤5ppm |
Melting point | Dry weight loss | Residue on Ignition | Heavy metal Total content (Pb) | Catalyst residue | Monomer residue | Solvent residue |
170~180℃ | ≤0.5% | ≤0.5% | ≤5ppm | ≤150ppm | ≤2% | 0.1% |