Pharmaceutical analysis and quality control (QC) testing compliance with international pharmacopeia specifications are critical from early-stage drug development to release. Analytical chemistry and microbiology testing are critical to the efficacy and safety of drugs.
Chemically synthesized small molecules are a typical route to pharmaceutical drug substances. Analytical development is a critical step to ensure the final product is as intended with no impurities.
Biopharmaceutical drugs present challenges in characterization and quantification. Innovative technical solutions and method development guidance ensure drug development with the highest degree of safety, purity, potency and compliance, as per ICH Q6B guidelines.
Compendial testing is a common part of drug product release. USP and EP, among other pharmacopeial standards, provide standardized methods and specifications for pharmaceuticals. Regulatory agencies continually update their guidance and it is important to stay abreast of changes.