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Analytical development is a critical step to ensure the final product is as intended with no impurities. [![A dandelion against a blue sky with multiple seeds drifting in the wind.](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/pharmaceutical-analysis-quality-control/dandelion290x180.jpg "Biologics Characterization")](https://www.sigmaaldrich.com/US/en/applications/pharmaceutical-and-biopharmaceutical-manufacturing/pharmaceutical-analysis-quality-control/biologics-biosimilars-characterization) [Biologics Characterization](https://www.sigmaaldrich.com/US/en/applications/pharmaceutical-and-biopharmaceutical-manufacturing/pharmaceutical-analysis-quality-control/biologics-biosimilars-characterization) 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. [![Six green pills with large check-marks in grey packaging.](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/pharmaceutical-analysis-quality-control/pharma-analysis-and-qc-290x180.jpg "Biologics Characterization")](https://www.sigmaaldrich.com/US/en/applications/pharmaceutical-and-biopharmaceutical-manufacturing/pharmaceutical-analysis-quality-control/compendial-testing-regulatory-guidance) [Compendial Testing & Regulatory Guidance](https://www.sigmaaldrich.com/US/en/applications/pharmaceutical-and-biopharmaceutical-manufacturing/pharmaceutical-analysis-quality-control/compendial-testing-regulatory-guidance) 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.  Top __Sign In To Continue__ To continue reading please sign in or create an account. 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