MilliporeSigma

Pharmaceutical Analysis & Quality Control

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.

Small molecules characterization, method development and validation, quality control and assurance (QA/QC), safety, purity, and potency
Secure Your Small Molecules Analysis & QC

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.

Biologics present challenges in characterization and quantification. Continuous development of techniques and applications assure easy characterization and manufacturing of the drug
Biologics 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.

Biologics present challenges in characterization and quantification. Continuous development of techniques and applications assure easy characterization and manufacturing of the drug
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.