PLGA microspheres are a biodegradable polymer with excellent biocompatibility, non-toxicity, and ability to form membranes and capsules. They are widely used in drug delivery systems, drug-release systems, and tissue engineering scaffolds for medical devices, as well as biodegradable surgical sutures, anti-adhesion membranes, and tissue engineering scaffolds.
Product Index:
PLGA(50:50)Microsphere
Item | Unit | Standard |
Reference Standard | Method | Result |
Appearance | / | / | / | Optical Microscopy | Spherical particle |
Median Size(D50) | μm | 75±10 | / | Laser Particle Analyzer | 70.84 |
Moisture | % | ≤0.5 | YY/T 0661-2017 | Karl Fischer Coulometric Titration | 0.24 |
L-lactide Monomer Residue | % | ≤2.0 | YY/T 0661-2017 | GC | 0.28 |
Glycolide Monomer Residue | % | ≤2.0 | YY/T 0661-2017 | GC | Qualified |
Dichloromethane Solvent Residue | ppm | ICH Limit Value | YY/T 0661-2017 | GC | Qualified |
Methanol Solvent Residue | 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 | US EPA 3052:1996 & US EPA6010D2018 | 62 |
*Produced in GMP workshop, each batch will provide the corresponding COA report.