Services

Quality Control

American Antibiotics Quality Control

American Antibiotics provides quality control and analytical development services focused on accelerating lead times and product development.

Analytical chemists develop and validate laboratory methodologies, monitor ongoing stability, and support the formulation and manufacturing process throughout development and commercialization. American Antibiotics R&D and Q.C. lab utilize some of the most advanced scientific equipment available such as UPLC, UPLC-MS, ICP, ICP-MS, DSC, TGA, and LC-MS. This equipment is used to characterize active pharmaceutical ingredients (API) and finished product which aids our scientists in formulating stable and scalable dosage forms. Having this advanced capability results in reliable data and dependable results.

Analytical development services Include:

  • Method development and validation
  • Cleaning residuals development and validation
  • Dissolution and drug release profiling
  • Forced degradation studies
  • Stability monitoring to ICH guidelines
Capabilities

American Antibiotics beta-lactam antibiotic manufacturing capabilities Include the following:

  • Tablets (uncoated, film-coated, enteric-coated and sugar-coated)
  • Capsules
  • Modified release tablets and capsules (extended release, delayed release and long acting)
  • Powders
  • Granules
  • Oral Suspensions
  • Injectables