PCL
PCL polymer (Polycaprolactone) has excellent biocompatibility, memory, biodegradability, etc. As a versatile medical-grade PCL material, it is soft, features good processability and excellent performance, and is widely used in various fields including tissue engineering.
Its degradation in vivo can be divided into two stages: the first stage shows that the molecular weight decreases continuously without deformation and weight loss; The second stage refers to that after the molecular weight decreases to a certain value, the material begins to lose weight and is gradually absorbed and excreted by the body.
Application:
Surgical suture, orthopedic splint, radiotherapy plate, resin bandage, dental impression, etc.
Product indicators:
Chemical formula: (C6H10O2) n
Viscosity average molecular weight: 1-1000000;
Intrinsic viscosity: 0.1-2.0dL/g;
Product appearance: White or light brown solid
Product Index:
| Item | Unit | Standard Values | Reference Standard | Method | Result |
| Appearance | / | White Solid | / | Visual Inspection | White Solid |
| Intrinsic Viscosity [η] | dL/g | / | GB/T 37642-2019 | 25°C，THF | 1.0 |
| Moisture | % | ≤0.5 | GB/T 37642-2019 | Karl Fischer coulometric titration |
0.12 |
| Monomer residue | % | ≤0.5 | YY/T 0661-2017 | GC | 0.16 |
| THF solvent residue | ppm | ≤720 | YY/T 0661-2017 | GC | Qualified |
| Total solvent residue | ppm | ≤1000 | 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 |
*Produced in GMP workshop, each batch will provide the corresponding COA report.
| Model No. | Intrinsic Viscosity [η] (dL/g) | Test Conditions |
| PCL02 | 0.20-0.26 | THF，25℃ |
| PCL04 | 0.35-0.43 | THF，25℃ |
| PCL08 | 0.70-0.90 | THF，25℃ |
| PCL12 | 1.00-1.30 | THF，25℃ |
| PCL17 | 1.50-1.90 | THF，25℃ |
