Analytical Analysis of Antibiotic Coated or Loaded Surgical Implants

Pine Lake Laboratories has a proven track record of developing and validating analytical methods used to insure the quality of antibiotic coated or loaded surgical implants.

Our experience spans a wide range of surgical meshes and dental implants. This experience combined with our expertise in performing FDA GMP compliant analytical analysis allows us to develop an analytical testing strategy to meet the unique and specific requirements of any antibiotic coated or loaded surgical implant.

We have worked extensively with surgical implants coated with the antibiotics rifampin (rifampicin) and minocycline. This previous work allows us to anticipate the stability and degradation products from both rifampin and minocycline.

Analytical Methods include:

-Assay/stability of the antibiotics by HPLC-UV

-Residual process solvents by GC-FID

-Drug release/elution by HPLC-UV

-Uniformity of coating by HPLC-UV

-Extractable and Leachable studies

-Identification of unknown process impurities/degradation products by UPLC-QToF

We have the capacity to perform routine analyses once the methods are validated and can assist in investigations of unexpected results. We have also transferred methods to QA laboratories at manufacturing sites.

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