Safety Data Sheets
We produce poly(DL-lactide) and poly(L-lactide), also referred to as PDLA or PLLA respectively, by ring-opening polymerization from lactide monomers. These linear aliphatic polyesters are often used in medical devices such as sutures, and scaffolds for tissue engineering. The LACTEL brand has been a reliable and proven source of these materials for 30 years.
Our range of PLAs encompasses monomer compositions from 100% PLA to 50:50 poly(lactide-co-glycolide). These products are offered in a range of molecular weights, as well as acid, hydroxy and ester end groups. Please refer to the table below.
For other PLAs, please contact us to discuss your requirements. We do a significant amount of custom synthesis for customers. For example, we can provide block and copolymers from mPEG and PEGs. We can perform additional purification to achieve residual monomer levels below 0.5 weight %, and manipulate other polymer characteristics to ensure the material performs to your requirements.
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.
|*Not routinely stocked. Please call for quote and availability.|