Your work demands precision; we understand that. And precision is the primary ingredient in every product we manufacture. It begins in our state-of-the-art facilities. Every product we manufacture undergoes rigorous testing to ensure it performs precisely as you expect. But we will do more, much more, to ensure that our polymers are the best in the world.
Lakeshore Biomaterials is committed to developing collaborative partnerships and to having the quality of our polymers make a significant contribution to the success of our client’s products.
Drug and Device Master Files (DMFs)
Lakeshore Biomaterials has filed appropriate Drug and Device Master Files (DMFs) in the United States and internationally).
Documentation
Certificate of Analysis (COA) / MSDS accompany many polymer shipments. Analytical Report / MSDS accompany every experimental polymer shipment.
Every Polymer that bears our name is tested to exact standards.
Quality Control Standard Tests
The following tests are run on our polymers; tests marked with an asterisk (*) are run on our experimental grade polymers.
- Inherent Viscosity*
The majority are measured at 30°C, 0.5% w/v in chloroform, with a size 25 Cannon-Fenske glass capillary viscometer. - Molecular Weight Determination by GPC
- Determination of Residual Monomers* by Gas Chromatography (experimental polymers by NMR)
- Determination of Glycolide/Lactide ratio* by NMR
- Tin Content
We also perform specialized test ot ensure your polymers meet your demands
The following tests are run if requested when purchasing
an entire batch (lot). These tests may require additional expense.
- Visual Appearance
- Determination of Water Content of Polymers
- Solubility
- Cloud Point Titration
- Determination of Average Glycolate Block Length by NMR
- Bioburden Testing
- Endotoxin Testing
- Heavy Metals — USP <231> Method II
- Purity and Melting Point Determination by DSC
- Others as requested