Safety Data Sheets
We produce poly(ε-caprolactone), also referred to as PCL, and poly(DL-lactide-co-ε-caprolactone) copolymers, also called DL-PLCLs. Polymers made from caprolactone are currently used in medical applications such as sutures and adhesion barriers. They are popular among researchers for tissue engineering for their relatively long half-life in vivo, degradation time, mechanical strength and elasticity.
Our PCL and DL-PLCL products are offered in various molecular weights. For the copolymers, two different monomer compositions are available. Please refer to the table below.
The LACTEL brand has been a reliable and proven source of these materials for 30 years. Our commitment to quality includes a thorough analysis of each lot of polymer, and every shipment of medical grade polymer includes a Certificate of Analysis (COA). Analyses include:
Other analyses can be provided if desired, including heavy metals, solubility and cloud point in various solvents, DSC, and other compendial tests. We also have considerable expertise in measuring molecular weights using GPC and NMR techniques.
DURECT maintains both Drug and Device Master Files with the FDA. All pharmaceutical grade polymer production is conducted in accordance with the International Pharmaceutical Excipients Council (IPEC) Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients, which are recognized and published in the United States Pharmacopeia. Polymers are produced in ISO 8 clean rooms with controlled temperature and humidity in our modern, well-equipped production and laboratory facilities in Birmingham, Alabama, USA.
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*Not routinely stocked. Please call for quote and availability. |